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December 9, 2011

Russia: World AIDS Day ITPC events, patients need tenofovir


December 1, 2011
ST. PETERSBURG
FlASHMOB AND STARS
December 1, 2011. The following activists and volunteers of non-governmental organizations in St. Petersburg and Leningrad region joined together for an unprecedented event associated with the World AIDS Day under the slogan “Know and Live”:
E.V.A. Non-Profit Partnership to increase the quality of life for women living with and affected by HIV-infection and other socially significant diseases,MadStyleGroup Creative Holding, MadMedia Communication Project, Dance4life Social Project, International Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru), Svecha Organization of People living with HIV, “Positive Dialogue” community of people living with HIV/AIDS, “Red Ribbon” Foundation and Salvation Army volunteers.
The event was held in two stages, the first part being a march from Anichkov Bridge to Gallery Trade Centre 6.30 p.m, joined by more than 200 people. The young activists walked along Nevskiy Prospect, telling the passers-by about the World AIDS Day. The participants stopped beside several subway stations, handing out booklets about HIV/AIDS and red ribbons to the passers-by with the following words: “HIV is not transmitted via information. Take care of your own health and the health of those you love”. In total, more than 2 000 copies were distributed. The second part took place in Gallery Trade Centre from 7.00 p.m. till 7.40 p.m. The people who were in the Gallery at that time got a chance to learn more about HIV epidemic, take part in a dance flashmob and enjoy a show involving stars of the Russian show business, T9 and In2nation pop groups and “Studio 17” dance group.
Another symbol of the event was a heart, to which everyone caring about the epidemic, being ready to take the responsibility for their own lives, and empathizing with those affected by the epidemic, could tie a red ribbon. By the event of the event, the heart was red with ribbons, and even after the end people with kept coming and tying their ribbons to the heart.
All the participants said that they managed to draw the attention of people in the Gallery and on the streets. In total, more than 400 people took part in the event.
DECEMBER 1 – MOSCOW
UNSANCTIONED PROTEST ACTION BESIDE THE MINISTRY OF HEALTH
Yet another protest action was held in front of the Ministry of Health of the Russian Federation by Patients Control Movement, with the funeral orchestra and two coffins representing failing treatment and prevention programmes in the country, leading to numerous deaths. The activists state that the absence of mandatory treatment guidelines puts the whole AIDS response in the country at risk. At the same time, several regions in Russia still face stock-outs of diagnostics and regimen changes due to non-clinical indications (as is underlined by the report issued within the framework of the Simona+ monitoring project). Russian patients still have no access to tenofovir, despite the facts that tenofovir-based regimens are included in the WHO guidelines. 

The event received broad coverage in the mass media, some activists were detained by the police and then released.

PRESS CONFERENCE HELD BY THE MINISTRY OF HEALTH
One of the Patients Control Initiative representatives took part in the press conference of MoH. At the end of the press conference, Ilya Lapin asked questions about the unsolved problems, namely lack of test kits, nevirapine for children, which has not been purchased by MoH, and absence of HIV treatment guidelines.

PRESS CONFERENCE WITH V. POZNER AND DANCE4LIFE
Alexandra Volgina spoke about problems with access to diagnostics, stock-outs of ART, lack of communication with MoH, and other issues raising concerns among the activists regarding access to HIV treatment in Russia.

ARTICLE IN ROSSIYSKAYA GAZETA (THE RUSSIAN NEWSPAPER)
Gaps in the list – Russia lacks essential medications for combating AIDS
Circulation: 185 445 copies (as of 2nd half of 2010). Coverage: 44 cities of Russia, with regional inserts and issue-related supplements. The newspaper issues a series of books with state documents and comments.

FAX ATTACK ON MoH

December 1
- 50 organizations from different countries sent a fax to MoH, drawing their attention  to the issue of access to tenofovir and nevirapine.
Nevirapine for children has not been purchased by the MoH, despite the fact that only one month is left till the end of the year.
Tenofovir is not included in the list of essential drugs, and MoH does not purchase it for Russian patients.

On average, a fax from activists was sent every ten minutes.



--
Best regards,
Sergey Golovin 
Public Relations Officer
Skype: sergej.golovin

August 12, 2011

April 25, 2011

HIV PrEP Explained: Critical Prevention Opportunity

by John S. James, AIDS Treatment News, April 25, 2011


The Good News

In late 2010 the New England Journal of Medicine published an authoritative report of a trial of PrEP (pre-exposure prophylaxis) in over 2,000 HIV-negative but high-risk gay men, showing that one pill a day of the approved HIV medicine Truvada could prevent HIV infection.[1] Science magazine listed this study as one of the top 10 achievements of 2010 [2]; and President Obama issued a statement about this trial.[3] For background, see [4].

The headline result is that Truvada was 44% effective (compared to placebo) in preventing HIV transmission in this population. This sounds disappointingly low. Why then is the study considered so important?

Much of the answer is that 44% is not the whole story. In the group randomly assigned to take a placebo, 64 became infected during the study; in the group randomly assigned to take Truvada, 36 became infected. Because the sizes of the groups were almost exactly equal (1251 participants, vs. 1248), you can compute the 44% by simple arithmetic.

Fortunately the study did blood testing of the 36 people who became infected despite being assigned to take Truvada, to see if they were really taking the drug. About 90% of them (33 of the 36) had no drug in their body when tested, at the last blood draw before they were found to have HIV. (Truvada consists of two drugs, and no detectable level of either drug was found in any of the 33 people.) The drug-level testing methods had been carefully validated, and can detect the active form of at least one of the drugs two weeks after people stop using the pills. Clearly these study participants had not been taking the medicine when tested. When these trial volunteers who were assigned to take the drug (but had not in fact taken it) were not counted, the effectiveness was not 44%, but over 90%.

It gets better. The other 3 participants who became HIV infected during the trial had very low levels of the active forms of the drugs, just above the limit of detection. Clearly they had taken some Truvada, but were far from using it as directed.

So of the 100 participants who became HIV-infected during this trial, 97 had not used Truvada at the time of the last blood draw -- and the other 3 had used it very poorly. Of those who actually took one Truvada pill per day throughout the study, not one became HIV-infected during this trial (vs. 64 of those who had been given the placebo). So for those who actually used the drug as directed, throughout the entire study, it was 100% effective in this trial, which had over 1,000 high-risk gay men assigned to take Truvada.

But the blood draws occurred in this study at weeks 4, 8, 12, 16, 24, and then every 12 weeks. So we cannot rule out the possibility that one or more people who had not taken Truvada for about two weeks or more before one of those visits, then got religion after the visit, and starting taking the pills daily -- yet got infected despite having adequate drug levels. This seems unlikely in view of the overall findings. But if it did happen, then it would mean that the protection was less than 100% in those who were using the drug. It was not possible to have everyone wear a device that that could record drug levels continuously -- and also tell exactly when they got HIV. So there is no way to be sure that nobody had enough drug in their body when they were infected. For this reason, 100% effectiveness is not claimed or reported.[5]

Still, the fact remains that Truvada for HIV prevention worked very well in this trial. Truvada when used properly (once a day, throughout the trial) completely prevented HIV infection, in a study of over 1,000 people -- when a comparable, randomly chosen group of 1,000 other people given a placebo had 64 HIV infections during the same time. Almost no drug for anything works this well.


Using PrEP Now

Since doctors can legally prescribe Truvada for prevention now, the U.S. CDC (Centers for Disease Control and Prevention) in January 2011 published interim guidance for physicians who want to use it to prevent HIV infection in high-risk HIV-negative men who have sex with men.[6,7]. Guidance will change as more information becomes available from other studies currently ongoing.

The main obstacle now is the price. Gilead Sciences, which holds the patent on Truvada, charges about 100 times as much for Truvada in the U.S., as other companies charge profitably for the same generic medicine in countries where Gilead's patent does not apply. And unless the FDA approves a formal "indication" for prevention use, insurance is unlikely to pay. This means that you can get Truvada for prevention in the U.S. today -- if you have over $12,900 per year to spend out of pocket -- or possibly, very good health insurance. (Gilead raised the price early in April, 2011; on April 18 we checked retail prices on Drugstore.com, which offers 90 once-daily pills for $3,180,90.)

Clearly PrEP will not be used enough to impact the epidemic, if individuals must pay so much out of pocket. (Just taking a $35 pill before sex is not expected to work. The body must convert both drugs into their active forms, which takes time.)


Adherence Issues

Some of the media discussion on Truvada adherence (taking one pill a day consistently) vs. effectiveness for HIV prevention is confusing, because in this study adherence was measured in different ways. Drug-level testing was clearly the gold standard -- while other methods, like asking people how often they took the pills, or counting pills returned, were often confusing, and much less reliable.

If any drug is so hard to take correctly that people seldom do so, then that drug is much less valuable. This is part of the reason that studies are most conservatively reported as “intent to treat” (counting everybody assigned to take the drug or other treatment as being treated -- even if they never actually take any of that treatment at all), instead of “on treatment” (counting only those who actually did take the drug -- partially a self-selected group, which could make the trial results hard to interpret). The purpose of intent-to-treat reporting is to make the study results both more accurate and also more relevant to social policy -- since doctors can only recommend a treatment, not make sure it gets used. In this case, the difference in result was huge: 44% effective, vs. over 90% -- or even close to 100% effective in this trial (depending on how you count the three participants with extremely low drug levels who were using the medication very poorly).

Why did so many of the study participants not take the Truvada?

No one knows for sure at this time. But something unusual and unexpected happened in this study. This clinical trial took place at 11 sites in 6 countries -- with two of the 11 sites in the United States (Boston and San Francisco -- with 113 U.S. participants on Truvada, 114 on placebo). And adherence at the U.S. sites was much better than at the non-U.S. sites -- 97% among all the U.S. participants, considered extremely good, compared to far less overall. The "44% effective" headline just averages these very different situations.

We know of three theories about this difference: (1) The U.S. participants were about 10 years older on the average (though this would hardly explain the huge adherence differences observed); (2) Many of the non-U.S. participants were living at home and probably not “out” to their families, so they would have needed to conceal their participation in the study, making adherence difficult; or (3) Boston and San Francisco have excellent HIV treatment access, perhaps the best in the U.S., while in many countries most people with HIV are dying with no treatment at all. So trial participants may have given or sold their pills to someone with immediate need.

We think that the latter is most likely.

Whatever the reason, the excellent U.S. adherence shows that people can use the drug properly for prevention. And in the future, patients will know that they are getting the active drug (not a placebo), and that it has been proven to work -- both of which should boost adherence. Researchers need to find out what went wrong at some of the sites, and learn how fix it.

But the bottom line is that we do have proof of principle that Truvada prophylaxis can work in high-risk gay men, and prevent close to 100% of the HIV infections that would otherwise occur.


Who Should Take Truvada?

No one we know thinks that all gay men should take Truvada.

But using this new prevention option in a targeted way should help a lot to control the HIV/AIDS epidemic. Remember that in any epidemic, if each person infected infects fewer than one other person on the average, and this can be maintained, then the epidemic will end.

And it turns out that a disproportionate amount of transmission takes place very early in someone's HIV infection -- when viral load is extremely high, but people do not know and seldom even suspect that they are infected, so they are much less careful about risk to others, than if they did know their status.

Also, in HIV as in most epidemics, a few so-called “superspreaders” account for a very disproportionate amount of transmission.[8] In HIV, they are much like those in the Truvada prevention study -- high risk, meaning that they have many sexual partners, especially with unprotected anal intercourse. (In the iPrEx study, volunteers were interviewed by the researchers, and those considered not to be at high risk were rejected -- so that the trial would be more likely to answer the question of whether or not this PrEP treatment worked.)

So far, the big problem in targeting early infection and/or superspreaders has been getting them diagnosed in time. Many are not aware of being sick at all during their early “primary” HIV infection, when they are so dangerous to their sexual partners. Most do get sick, but with the flu-like symptoms of an ordinary viral infection. They or their doctors have no reason to suspect that they have HIV. And if they do take a standard HIV antibody test, they will test negative even though they have a very high HIV viral load, because the body has not formed antibodies against HIV yet.

Recently there has been much interest in trying to stop the HIV epidemic by a policy of “test and treat” -- find people and get them into treatment right away, because on treatment their HIV viral load will be hundreds of times less than before, and they will be much less likely to transmit the infection to anyone else. One recent study [9] concluded that test-and-treat alone will not be enough in the United States, where only 19% of people with HIV have an undetectable viral load -- a "shocking" figure due largely to poor access to care. And it is very hard to find newly infected people soon enough.


PrEP's Big Advantage with Test-and-Treat

With effective PrEP, the problem of early HIV diagnosis goes away. If the high-risk individual never gets infected in the first place, a whole branch of the epidemic tree can be cut off. And as we explained above, the effectiveness of Truvada PrEP in gay men has been close to 100% so far, when it has been used properly (one pill a day, taken consistently).

The way to identify high-risk individuals is to let them identify themselves. After a conversation with their doctor (or a specialist physician at an AIDS organization), and with testing to make sure they do not already have HIV (in which case they would need medical management, not PrEP), they should be able to get a one-pill-a-day supply of the drug without obstacles. Periodic testing could be required, to guard against side effects (such as possible kidney damage), and to make sure the patient is still using the drug, and does not have HIV.

Of course there will be some worried well who end up taking Truvada for prevention even though they do not need to. The doctor can explain the small but real risks of doing so. Truvada is one of the least problematic AIDS medicines.

Note that the “superspreaders” are usually the same high-risk individuals who have many sexual partners and do not take needed precautions. They know who they are. And their own interest in protecting themselves closely parallels the public interest in stopping the HIV epidemic.

Notice that PrEP gives people a new, big incentive to get tested -- the chance to avoid HIV entirely if they get the good news, perhaps even without changing their sexual practices -- not just the chance to start treatment earlier in case of bad news.

We need combination HIV prevention; no one size fits all. But we now know that Truvada PrEP can provide very good protection for high-risk men who have sex with men. And by doing so, it will also be a major tool to help control and eventually end the global HIV epidemics.


Note on FEM-PrEP Trial Closing

Shortly before we went to press, a similar Truvada PrEP trial in women failed, and was closed early. It was ended because exactly the same number of women were infected in the group assigned to take Truvada, as in the group assigned to take the placebo. The study's Independent Data Monitoring Committee secretly examined these interim results, and determined that this trial was very unlikely to show that Truvada PrEP worked in the women. Therefore, the trial was stopped, due to "futility."

Why did the same iPrEx study drug work in men but not in women? No one knows. Blood samples were saved, and drug-level testing and other data will need to be analyzed, to see what can be learned.

There are at least two plausible theories as to why this may have happened:

(1) The iPrEx trial focused on anal HIV transmission, FEM-PrEP on vaginal. It is possible that oral Truvada does not block vaginal transmission, probably because it does not reach high enough levels in the vagina.

(2) There is also another possibility. As explained above, the iPrEx trial worked much better at the U.S. sites (Boston and San Francisco) -- than at other sites, where participants would often have strong reason to give their medication to someone who was sick due to HIV, and not tell the researchers. All of the FEM-PrEP sites were in Africa, where access to life-saving HIV treatment is much worse than in Boston or San Francisco. Unlike iPrEx, FEM-PrEP had no U.S., European, or other sites where no one would need to divert the pills to save the life of a family member or friend.

Neither one of these two possibilities would contradict the iPrEx results -- or the CAPRISA 004 results. In either case, both these studies remain as solid as they ever were.

Note: Truvada alone is not considered proper HIV treatment today, since at least one other anti-HIV drug is needed to more fully suppress the virus and prevent it from developing drug resistance. But if no other treatment is available, Truvada alone might restore someone with AIDS to health and save their life for some time. It is probably better than any HIV treatment anywhere before 1996. Of course it would be much better to take Atripla (or a generic equivalent, or a comparable combination); Atripla is Truvada plus a third drug that works well with it, a modern HIV treatment in one pill per day.

We will report new information as it becomes available.


References and Footnotes

[1] Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men. New England Journal of Medicine (full text free); December 30, 2010, published online November 3, 2010, http://www.nejm.org/doi/full/10.1056/NEJMoa1011205.

Later analysis of the trial, not ready for the above publication, was included at the 18th Conference on Retroviruses, especially in the March 1, 2011, 10:00 a.m. session, "Advances in PrEP," at http://www.retroconference.org/2011/data/files/webcast_2011.htm (you need to select 'Tuesday'). Besides the Scientific Overview, also note “Adherence Indicators and Interim Guidance: Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men," and "PrEP Drug Levels in the iPrEx Study,” later in the same session.

[2] Science Magazine Names USAID-Funded HIV Research As Top 10 Breakthrough of the Year. [Both the CAPRISA trial (1% tenofovir vaginal gel for women) and the iPrEx trial (Truvada, a tenofovir + FTC pill for men) made the top-10 list.] Medical News Today, December 28, 2010, http://www.medicalnewstoday.com/articles/212499.php

[3] White House press release, November 23, 2010, http://www.whitehouse.gov/the-press-office/2010/11/23/president-obama-welcomes-new-hiv-prevention-research-results

[4] Background note: This international clinical trial is called iPrEx, which is an abbreviation for the Spanish name of the study; many participants were in Spanish-speaking countries. It used Truvada, a common HIV treatment marketed by Gilead Sciences; Truvada consists of two drugs, tenofovir and emtricitabine, combined in a single pill taken once a day. A related HIV prevention study in women, using a vaginal gel containing tenofovir, was also successful (CAPRISA 004, also recognized in the Science top-10 list. But a prevention trial using Truvada in women recently failed; see the discussion of FEM-PrEP in the text above.

[5] A major reason the "44%" effective (instead of "close to 100%") is widely headlined, instead of is that researchers are expected to highlight the study analysis that they planned in advance to do -- not other analyses that they may choose after looking at the study results. In this case, the planned analysis was the overall HIV-prevention result, with all the study sites considered together. The huge difference between the U.S. and some of the other sites was not expected.

The U.S. sites showed proof of principle that taking one Truvada pill a day can work very well to prevent HIV infection. The sites where people did not take the pills showed that these sites had other problems, which need to be investigated and addressed.

Those interested in statistical methods will note that headlining the pre-planned analysis turned out to be misleading in this case, because of the emergence of a "black swan" -- something totally unexpected which changes the entire picture. As seen also in the financial world (http://www.guardian.co.uk/business/2011/apr/05/world-economy-faces-black-swans-imf-strauss-kahn), modern analysis does not handle black swans well. In clinical research, a major purpose for favoring hypotheses stated in advance is to prevent researchers from falsely enhancing the value of their study by building hypotheses around the resulting data -- including its random variations.

We believe that an analysis revolution is possible here, since there must be better ways to handle these problems that what is done today. As a stopgap, we suggest letting medical researchers claim a black-swan exemption, when justified by an unexpected result that changes the whole picture -- giving them more freedom to highlight interpretations developed after they had seen the results, while also calling in more scrutiny from other professionals, to check that they were using the exemption in ways that were not misleading, and that made practical sense overall.

[6] Interim CDC Guidance on Pre-Exposure Prophylaxis for HIV Prevention in MSM (short overview with highlights for physicians, January 28, 2011), http://aids-clinical-care.jwatch.org/cgi/content/full/2011/214/1

[7] Interim Guidance: Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men (the official document), http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a1.htm

[8] On the importance and the difficulty of reaching superspreaders in HIV, see: Autonomous targeting of infectious superspreaders using engineered transmissible therapies. PLoS Computational Biology; March 17, 2011, http://www.ploscompbiol.org/article/info%3Adoi%2F10.1371%2Fjournal.pcbi.1002015.

[9] Test-and-treat not enough to control HIV epidemic in the US, http://www.aidsmap.com/Test-and-treat-not-enough-to-control-HIV-epidemic-in-the-US/page/1724334/

Note: This post is Part I. We are researching Part II, on obstacles and opposition to using Truvada PrEP for individual protection, or to help end the HIV/AIDS epidemic. Part II will be controversial.

March 10, 2011

Changes to AIDS Treatment News blog

I'm planning changes to this blog and would like to hear what you think (either publicly by a comment, or privately by email to aidsnews@aidsnews.org).

My current thinking is to move the news stories to the right-hand column (via Twitter, but you do not need to use Twitter to read them). Then the main column of the blog will be for discussion, usually around one or more of the news stories.

The previous format was not good for discussion - largely because readers seldom saw blog comments, since they quickly got buried by all the news items coming in. And Twitter encourages many equal voices - important for community discussion and idea development.

The new format should result in more news stories, fewer blog posts, more interaction, and more in-depth discussion.

Thoughts?

February 24, 2011

Get Twitter Announcements for Retroviruses Conference and Beyond - CURE4

AIDS Treatment News set up Twitter account cure4 for communication at the 18th Conference on Retroviruses (formerly called CROI), February 27 - March 2 in Boston.

Main purpose: to let activists and writers at the conference know about important events before they happen. We also tweet conference and related news. We already have 58 tweets there, 3 days before CROI begins.

Anyone can read our tweets; you do NOT need a Twitter account. Just visit twitter.com/cure4. Or see the latest announcements on this page, in the right-hand column.

Alternatively, you can follow cure4 on almost any mobile phone (even without a Twitter account). Just send the text message:
follow cure4
to 40404 (Twitter's U.S. short code -- see Twitter support for more info). To turn off the tweets, send:
unfollow cure4
Note that capitalization does not matter.

If you do have a Twitter account and want us to retweet conference-related events and news, then include the hashtag #cure4 in your tweet, so we can find it quickly.

Statins Might Help HIV Patients, Study Suggests

HON: "Preliminary research suggests that statins restrain the immune systems of HIV patients and may stave off progression of the AIDS-causing virus.

Although it's too soon to recommend the drug for this purpose, the findings of this small study raise the possibility that 'there might be drugs that can help adjust the immune response in HIV patients whether they're taking AIDS medications or not,' said Dr. Brian Agan, director of HIV research with the Infectious Disease Clinical Research Program at the Uniformed Services University in Bethesda, Md. He works with some of the study's authors."

U.S. & U.K political climate impacting HIV prevention

Chelsea Now: "As each speaker came to our class, a clear theme of regression began to emerge. Where once these same speakers had talked about social and contextual influences of risky sex and substance use, they now spoke of campaigns based on overly simplistic notions of individual responsibility without context or social influence. We also heard about cuts to NHS funding and a shifting of responsibilities from medical providers who have spent years learning about and treating person with HIV to clinicians who are our equivalent of general practitioners/ family clinicians, untrained in the complexities of HIV medical care."

In Kato’s Africa, USAID Money Spurred Spread of HIV Criminalization Laws

Housing Works: "A decade ago, not a single African country had a law that specifically criminalized HIV exposure. Now, at least 27 African nations punish exposure. These laws open the door for the jailing—or worse—of people with HIV who practice safer sex; mothers who transmit the virus to their children; and even those who have HIV but are undiagnosed.

"The spread of such laws is in part the result of a 2004 model law created by Action for West Africa Region-HIV/AIDS, a five-year project funded at just under $35 million by USAID.

“By funding the creation—and wide dissemination—of a ‘model’ HIV-specific law, USAID has sent mixed messages from the United States,” said Edwin Bernard, editor of HIV and the Criminal Law. “On the one hand, the model law supports human rights by criminalizing stigma and discrimination. But by using vague and imprecise language in its HIV criminalization statute it also creates fear, confusion and the further stigmatization of people living with HIV.”

February 22, 2011

Nano-sized vaccines

MIT news release: "MIT engineers have designed a new type of nanoparticle that could safely and effectively deliver vaccines for diseases such as HIV and malaria."

February 21, 2011

CDC Estimates Half of New HIV Infections Occur Among Black Americans

HIV/AIDS Clinical Care: "CDC researchers analyzed data on new HIV diagnoses from 2005 through 2008 in 37 states that had longstanding HIV surveillance systems. Although blacks made up only 14% of the population in these states, they accounted for half of the new HIV diagnoses made. Forty-five percent of the men with new diagnoses were black, as were 66% of the women."

Dr. Robert C Gallo Interview: HIV Research at a Crossroad?

hiv-reservoir.net (Jan. 13, 2011): "Alain Lafeuillade: it looks like the terms ‘HIV sterilizing cure’ and ‘HIV functional cure’ are no longer ‘dirty’ words for scientists. What is the main gap in our knowledge about HIV persistence that should be resolved before we can envision new strategies to reach these goals?

"Robert C. Gallo:  The answer is clearly demonstrating the precise cell types that are the source of persisting HIV.  This means cells that go beyond the common memory T cells that currently are chiefly studied, and demonstrating that by so-called “purging” these cells by activation mechanisms will lead to death of these cells.  At the moment this is the assumption."

February 20, 2011

Fast online review of antiretroviral advances at CROI, March 3

ViralEd: "This 1.5-hour live Internet symposium will review and discuss the key studies on antiretroviral therapy presented at the 18th Conference on Retroviruses and Opportunistic Infections. The symposium will feature five well-known and recognized thought leaders in the HIV field, with four serving as presenting faculty/discussants and one as program moderator."

Comment (JSJ): There will be many reviews of the important Conference on Retroviruses and Opportunistic Infections (CROI) in Boston (Feb. 27 - March 2), most of them weeks or months later. This review has 5 top experts -- and happens on March 3, the day after the conference ends. It's free online for anyone, but you need to preregister.

I'm attending CROI, but will also watch this summary on the antiretroviral therapy advances presented there.

Positively Confined

Positively Confined [POZ blog]: "An HIV positive man incarcerated somewhere in America shares his insight and advice from behind bars."

Safety, Efficacy, and Pharmacokinetics of TBR-652, a CCR5/CCR2 Antagonist, in HIV-1-Infected, Treatment-Experienced, CCR5 Antagonist-Naive Subjects

JAIDS Journal of Acquired Immune Deficiency Syndromes: "Conclusions: TBR-652 caused significant reductions in HIV-1 RNA at all doses. Significant increases in MCP-1 levels suggested strong CCR2 blockade. TBR-652 was generally well tolerated with no dose-limiting AEs. PD indicate that TBR-652 warrants further investigation as an unboosted, once-daily, oral CCR5 antagonist with potentially important CCR2-mediated anti-inflammatory effects."

February 18, 2011

Most detailed 3D-model of HIV ever made

Photoblog: "The winners of the 2010 International Science and Engineering Visualization Challenge, sponsored jointly by the journal Science and the National Science Foundation, share spectacular photographs, graphics, illustrations and videos that engage viewers by conveying the complex substance of science through different art forms. This detailed 3-D model of the human immunodeficiency virus won first place in the illustration category."

February 16, 2011

Statins as Anti-inflammatory Therapy in HIV disease? — J Infect Dis

J Infect Dis: "The present study has additional limitations. Unfortunately, levels of inflammatory serum proteins, such as C-reactive protein, were not measured. Moreover, the duration of statin exposure was only 4 weeks, so it is not known whether the anti-inflammatory effects observed would be sustained with longer statin exposure.

"Unless other statins have modes of action that are different from those of high-dose atorvastatin, it seems unlikely that other statins will be found to suppress HIV replication. However, the present data suggest that statins merit evaluation over longer periods in HIV-infected adults who are receiving effective antiretroviral therapy but who have persistent T cell activation, given that ongoing inflammation in HIV-infected adults receiving therapy is associated with a greater risk of HIV disease progression and death. A very large study would probably be required to determine whether the potentially positive effects of statin therapy on inflammatory biomarkers will translate into less HIV disease progression and fewer cases of inflammatory non–AIDS-related illnesses, such as cardiovascular disease and end-stage liver disease."

Learn From Zim How To Fight HIV/AIDS

RadioVop Zimbabwe: "'The modelling showed it couldn't just be the natural curve [of the epidemic]; the decline was too dramatic,' he told IRIN/PlusNews. 'The modelling suggested it was also due to behaviour change and behavioural data also suggested a change, but what was missing was the all important `why'.'

According to Halperin, Zimbabwe's success story points to the power of social change and the need for more detailed analyses of HIV success stories in Africa. He compared it to the role of partner reduction in the fight against HIV in Uganda, which promoted a reduction in concurrent partners as the key focus of its HIV prevention campaigns in the late 1980s and early 1990s."

Stop Using Laws as Weapons Against HIV Prevention

Open Society Foundations Blog: "These stories stand beside countless others as testament that what is written in the statute books, and what is done by governments and others in the name of the law, can significantly increase the vulnerability of groups that are already at a high risk of HIV and other serious diseases. This week in Bangkok, Thailand, civil society groups that represent sex workers, drug users, men who have sex with men, people living with HIV, women and children, and those seeking access to essential medicines, will sit down with government officials and policymakers from across the Asia-Pacific region to share their experiences of how the law affects their daily lives."

Interim CDC Guidance on Pre-Exposure Prophylaxis for HIV Prevention in MSM - HIV/AIDS Clinical Care

HIV/AIDS Clinical Care: "These guidelines provide basic recommendations for clinicians who are interested in implementing PrEP based on the data that are currently available."

February 15, 2011

New Cure-Related Research: Antabuse to Flush HIV Reservoir

POZ, Feb. 8: "A new clinical trial has just gotten underway to test the ability of Antabuse (disulfiram)—a drug used for years to treat alcoholism—to flush out the hidden reservoir of HIV that evades both the immune system and antiretroviral (ARV) drugs. Though the trial will be small and isn’t seeking to cure the study participants, it could help propel HIV cure research forward."

Math Wizards Develop New HIV Drug Candidates

POZ, Feb. 9: "Using a blend of high-level math and chemical engineering, a team of researchers at Princeton University has discovered several new drugs that their colleagues at Johns Hopkins University in Baltimore say are potent against HIV. Their process for finding new drugs against diseases, outlined in a paper published online November 17 in Biophysical Journal, could significantly speed up the laborious task of searching for and testing promising chemical compounds."

February 14, 2011

Sutherlandia plant begins HIV drug safety trials

SciDev.Net: "A traditional medicine that may relieve symptoms in AIDS patients is to undergo safety and efficacy tests in South Africa.

"The department of science and technology (DST) has awarded 10 million rand (US$1.4 million) for the study of Sutherlandia frutescens, which is often called the 'cancer bush' and is credited with wide-ranging powers to alleviate symptoms.

"The phase IIb trial will be conducted at the University of the Western Cape's South African Herbal Science and Medicine Institute (SAHSMI), which has been conducting scientific and clinical studies on the plant for seven years."

HIV Protection Without Circulating Blood Antibodies

Biomed Middle East: "New research shows that protective immunity against HIV can be achieved without the presence of virus neutralizing antibodies in the blood. The study, published by Cell Press in the February issue of the journal Immunity, demonstrates that a vaccine which stimulates production of specific anti-HIV antibodies in the vaginal tissue was sufficient to protect monkeys from exposure to live virus. The results may also help to explain why a few individuals who lack anti-HIV antibodies in the blood are able to resist infection, even when they are repeatedly exposed to HIV. ...

"We may have been able to recapitulate in a vaccine what a few individuals do naturally."

HOUSE REPUBLICANS PROPOSE MASSIVE CUTS TO HIV/AIDS PROGRAMS

The AIDS Institute: "'While there is a waiting list of over 6,000 people in ten states to receive lifesaving AIDS medications from the Ryan White HIV/AIDS Program AIDS Drug Assistance Program (ADAP), and thousands more are being removed from the program, the House Republican spending proposal will seriously exasperate the crisis,' added Schmid. Low income people with HIV/AIDS were counting on an increase of at least $65 million, including continuation of $25 million that state ADAPs received this summer to help reduce the waiting lists. 'Not only did the House Republicans erase any funding increase, they failed to continue to fund the $25 million in FY11 and, in effect, will be taking away medications from people. If we have long wait lists now, just imagine what the situation will be like next year with no increases in funding,' he added. Access to early quality care and treatment keep people with HIV/AIDS healthy and free from opportunistic infections, resistance to medications, and away from expensive emergency rooms.

"'With over 56,000 new HIV infections annually in the U.S., now is not the time to cut CDC’s prevention funding,' said Michael Ruppal, Executive Director of The AIDS Institute. 'We only spend 3 percent of our federal HIV spending on prevention. Cutting CDC’s budget by 15 percent and prohibiting scientifically proven effective prevention programs, such as syringe exchange, will lead to even more HIV infections,' he added. The bill even goes as far as preventing the District of Columbia, a place with one of the highest rates of HIV in the country, from spending its own money on syringe exchange programs. It is far more cost-effective to invest in prevention now rather than paying for care and treatment later. Preventing one infection will save approximately $355,000 in lifetime medical costs. Preventing all the new 56,000 cases in just one year would translate into an astounding $20 billion in lifetime medical costs.

"The proposal authored by the House Republicans cuts research funding at the National Institutes of Health by over $1.6 billion. Investing in HIV research will help in the discovery of new medications, new tools in the prevention of HIV, including vaccines, and ultimately a cure. 

"The bill cuts over $500 million from the U.S. historic humanitarian commitment to treating and preventing HIV in the poorest countries in the world, where the economic downturn has crippled economies and their people. "

February 13, 2011

Africa: U.S. Seeks to Cut Costs in Sustained War Against HIV/Aids

allAfrica.com: "Goosby said that PEPFAR has a special focus on children.

"'In the last year alone, we have been able to prevent 114,000 transmissions to children during pregnancy of HIV-positive mothers,' he said, adding that 3.8 million vulnerable children are cared for by PEPFAR programs. 'From birth until they are 18 years old, we feed them, clothe them, house them, educate them, train them for jobs and turn them loose, and we have a case management relationship with them as they go into young adulthood. This is a remarkable example of the American people's tax dollars having a high impact to stabilize lives and save lives, stabilize communities and stabilize countries.'"

February 12, 2011

Chinese AIDS activist jailed for criminal damage

Asiaone.com: "Tian has campaigned for compensation to be given to thousands of Chinese who contracted HIV, the virus that causes AIDS, through blood transfusions.

"He was told shortly before his arrest that local authorities had demanded he be detained, according to China's Aizhixing Association for the Fight Against AIDS.

"Tian had worked for the group, helping to uncover a scandal over the trafficking of blood in the 1990s in Henan Province, which led to more than 150,000 people becoming infected with HIV."

Fear factor in Aids breakthrough

Times LIVE, Zimbabwe: "'Given the continuing, and worrying, trend for high HIV/Aids infection rates in many sub-Saharan African countries, we felt it was important to understand why the disease has taken such a dramatic downturn in Zimbabwe. Very few other countries around the world have seen reductions in HIV infection and of all African nations, Zimbabwe was thought least likely to see such a turnaround. This is why there was such an urgent need to understand its direct and underlying causes,' said Professor Simon Gregson, who was part of the research team based at the School of Public Health at Imperial College London. ...

"Zimbabwe had one of the highest HIV/Aids rates in the world over a decade ago. But these infection rates have been halved from 29% in 1997 to 16% in 2007. This happened amid massive social, political and economic instability. In 2003 Zimbabwe was estimated to have 1.8-million people infected out of a population of 12-million.

"The study further stated that the difficult economic environment played a key role in ensuring that men reduced the number of multiple concurrent partners, as this meant digging more into their wallets."

Big Pharma shows willingness to pool HIV and Aids drug patents

guardian.co.uk: "Not long ago there were those who doubted whether the Geneva-based Medicines Patent Pool would manage to persuade any of the big pharmaceutical companies that it was a reasonable idea to allow their patents on Aids drugs to be 'pooled'. Unitaid, which works to improve access to medicines in developing countries and set it up, argued long and hard that the pool was necessary. It would allow generic manufacturers in countries like India and China to make legitimate cheap combinations of some of today's advanced HIV medicines. Cheap new combinations are going to be vital in the fight to keep millions alive in the developing world as HIV inevitably develops resistance to the basic drugs now available in poor countries.

"But today, two months after sending out letters inviting the major makers of Aids drugs to get involved, the patent pool announced that it is in negotiations or preparing to enter negotiations with F. Hoffman-La Roche, Gilead Sciences, Sequoia Pharmaceuticals, and ViiV Healthcare (a joint venture of GlaxoSmithKline and Pfizer). The big surprise for the sceptics is Viiv."

Sangamo's Bet Against AIDS: Gene Therapy

BusinessWeek: "Timothy Brown may be the only person cured of AIDS. Brown, who lives in San Francisco, in 2007 received a stem-cell transplant in Berlin that transferred genetic material to him from one of the up to 2 percent of humans with a natural immunity to the disease. He has been off treatment since then, and no traces of the AIDS virus have been found in his body, says his hematologist, Gero Hütter, now with the German Red Cross in Mannheim. His case has encouraged tiny Sangamo BioSciences (SGMO) to develop a new form of gene therapy that could offer others the same result."

February 7, 2011

PEPFAR’s Smart Investments to Save More Lives: Efficiencies, Innovation, Impact

U.S. DEPARTMENT OF STATE: "On Thursday, February 10, 2011, PEPFAR will hold a one-day forum entitled “PEPFAR’s Smart Investments to Save More Lives: Efficiencies, Innovation, Impact.” The meeting will spotlight PEPFAR’s work to gain greater impact and efficiency through smart investments in programs working to save lives from HIV/AIDS. The discussion will build upon PEPFAR’s ongoing efforts to maximize the impact of every dollar spent."

Note: Draft agenda at https://asoft130.securesites.net/secure/causda/clientuploads/design/Pepfar/SmartInvestments/DRAFT_Agenda-PEPFAR_Smart_Investments_Meeting.pdf

Race, Sex, and Clinical Outcomes in Early HIV Infection

HIV/AIDS Clinical Care: "Of all the groups analyzed, nonwhite women in the South had the highest rate of HIV/AIDS-related events (81%).

"Comment: The data presented in this paper open the door for further investigation into the influence of biology on the course of HIV infection. However, removing sociodemographic barriers to optimal care will likely have a much greater impact on outcomes than understanding biological determinants of progression and response to treatment."

February 5, 2011

Simple life changes could stop millions of cancers

Reuters: "About a third of all common cancers in the United States, China and Britain could be prevented each year if people ate healthier food, drank less alcohol and exercised more, health experts said on Friday."

February 4, 2011

Mouse hormone trial raises hopes for HIV cure

ABC Australia: "MARC PELLEGRINI: If we treat those mice with interleukin therapy we can actually clear this virus which is really quite overwhelming in the mice and is never cleared.

"So if we have two cohorts of mice, one given a placebo, those mice never clear the infection and it really overwhelms the immune system and the immune system succumbs to the disease.

"Whereas in the mice that are treated with interleukin-7 for three weeks we can actually effect the cure such that the virus is actually eliminated from their blood and from most of their, or indeed all of their organs like the lung and the brain which are sort of reservoirs for that particular virus in the mice.

"SIMON LAUDER: Does it follow that the same therapy could be used to clear HIV in humans?

"MARC PELLEGRINI: It would certainly follow that the same therapy could be used to boost immunity in HIV and either better control or perhaps even cure HIV in the long term."

Note: Technical abstract at http://www.cell.com/abstract/S0092-8674(11)00012-2.

February 2, 2011

Florida Avoids HIV Medication Crisis: Welvista Agrees to Provide Free Drugs Until April 1 - Miami News - Riptide 2.0

Miami New Times - Riptide 2.0: "Roughly a week before Florida was set to exhaust all funding for its life-saving AIDS Drug Assistance Program (ADAP), non-profit pharmacy Welvista has agreed to help the cash-strapped state by providing poor Floridians with free anti-retroviral medications.

"As we wrote last week, the funding snafu threatened to disrupt treatment for over 10,000 state residents who can't afford HIV medications. Now approximately 6,500 ADAP recipients will be covered until state funds kick in on April 1. But activists who helped negotiate the deal warn that it's a temporary fix.

"None of us are happy with the Florida fiasco," said Lynda Dee, a spokesperson for the Fair Pricing Coalition, which helped broker the deal.
In fact, the donated meds just reduce the number for other HIV patients, such as those already stuck on an ADAP waiting list, she said in a statement issued Tuesday afternoon. The real answer, Dee argued, was more funding for the drug program.

"We clearly recognize this is a one-time, emergency rescue of a program that cannot be repeated or duplicated by Florida or any other state," she said. "We therefore implore the federal government and all state governments, especially Florida, to provide adequate funding to state ADAPs to meet the medication needs of its uninsured people living with HIV."

Open Access and the developing world | Improving access

Biomed Central "Open access to the results of scientific and medical research has potential to play an important role in international development, and this conference will discuss the benefits of open access publishing in an African context, from the perspective of both readers seeking access to information, and researchers seeking to globally communicate the results of their work."

Comment: The conference occurred in Nairbi in November 2010, and videos of the presentations are now online.

Senate GOP To Attach Health Care Repeal As Amendment to FAA Reauthorization Bill

The Note -- ABCnews.com: "Now the GOP is poised to push Democrats into allowing a full repeal vote. In the past few days Democrats have touted the FAA reauthorization as the “first jobs bill” of the new Congress & said it would save or create an estimated 280,000 jobs"

Comment: Republicans are trying to repeal the whole healthcare reform bill, by tying it to jobs legislation in the Senate.

WIPO, WTO to hold 2nd technical symposium on patents, access to medicines

World Trade Organization: "World Health Organization (WHO), World Intellectual Property Organization (WIPO) and World Trade Organization (WTO) will hold a technical symposium on “Access to Medicines, Patent Information and Freedom to Operate” on 18 February 2011 at the World Health Organization in Geneva. Before this second in a series of joint symposiums, an optional workshop on “Patent searches and freedom to operate” will be offered on 17 February 2011."

Flaw in induced-stem-cell model

Nature News: "Medical researchers' hopes of replacing politically fraught embryonic stem (ES) cells with stem cells derived from adult tissues have suffered a setback. ...patterns of epigenetic changes — alterations that affect gene expression without changing the DNA sequence — tell a different story about iPS cells, a team led by Joseph Ecker, a molecular geneticist at the Salk Institute in La Jolla, California, reports online in Nature this week."

Tough on truth

Nature : Nature Publishing Group: "'Fraud plagues global health fund,' screamed the title of an article published last month by the Associated Press ...

"The reputation of the fund — which by its own estimates saved more than 4.9 million lives by 2009 — has been unfairly tarnished, and its fund-raising efforts perhaps hampered at a time when the economic crisis is already making donors reconsider the size of their contributions.

When it comes to being transparent over problems of corruption in recipient countries the Global Fund has been far better than most aid donors or agencies"

State of Florida to Move 6,000 People From Life Saving AIDS Drug Assistance Program (ADAP)

The AIDS Institute: "Tampa, FL – In an unprecedented move in the treatment of HIV/AIDS in the United States, the State of Florida is finalizing a plan to move 6,000 low-income people from its AIDS Drug Assistance Program (ADAP).  The Florida ADAP program currently serves about 10,000 people across the state but officials say they only have enough money left to support roughly 3,500 patients until April 1, 2011 when new federal dollars are expected.

“This is devastating,” stated Michael Ruppal, Executive Director of The AIDS Institute. “Efforts to fill the financial gap from additional state or federal sources have yielded nothing. We are in a perfect storm with the loss of jobs and health insurance, increased infections and increased diagnoses through expanded testing programs, while at the same time State and Federal governments are cutting their budgets.” Ruppal continued, “We are risking peoples’ lives with the potential of treatment interruptions that dramatically increase their chances of becoming resistant to the same drugs that are currently saving their lives.”

"ADAP’s provide HIV-related medications to uninsured and under-insured people living with HIV/AIDS or about one-quarter of the people with HIV/AIDS estimated to be receiving care in the U.S. ADAP is part of the Ryan White HIV/AIDS program, which is funded by both federal and state resources. Receiving medications daily is critical to effective AIDS treatment."

January 29, 2011

Johnson & Johnson/Tibotec AIDS Drug Licenses Exclude Too Many Patients

Doctors Without Borders: "Licenses just agreed between three generic manufacturers and pharmaceutical company Tibotec, owned by Johnson & Johnson, will keep a promising new AIDS medicine out of the hands of many patients across the developing world, the international medical humanitarian organization Médecins Sans Frontières (MSF) said today. The licenses exclude many developing countries where Johnson & Johnson/Tibotec will likely charge high prices. Other precise restrictions introduced by the agreement must be scrutinized carefully.

"Tibotec has licensed production of the antiretroviral medicine rilpivirine to one South African and two Indian manufacturers, but has limited the geographic scope of the licenses such that all of Latin America, Central Asia and most Caribbean and South East Asian countries will not be able to receive generic versions of the medicine. Given the restrictive licensing, these countries may not be able to import generic versions from India even if they override patents in their countries through compulsory licenses."

Murder of Ugandan LGBT Activist David Kato

U.S. Secretary of State Hillary Clinton: "We are profoundly saddened by the loss of Ugandan human rights defender David Kato, who was brutally murdered in his home near Kampala yesterday. Our thoughts and prayers are with his family, friends, and colleagues. We urge Ugandan authorities to quickly and thoroughly investigate and prosecute those responsible for this heinous act.

"David Kato tirelessly devoted himself to improving the lives of others. As an advocate for the group Sexual Minorities Uganda, he worked to defend the rights of lesbian, gay, bisexual, and transgender individuals. His efforts resulted in groundbreaking recognition for Uganda's LGBT community, including the Uganda Human Rights Commission's October 2010 statement on the unconstitutionality of Uganda's draft 'anti-homosexuality bill' and the Ugandan High Court's January 3 ruling safeguarding all Ugandans' right to privacy and the preservation of human dignity. His tragic death underscores how critical it is that both the government and the people of Uganda, along with the international community, speak out against the discrimination, harassment, and intimidation of Uganda's LGBT community, and work together to ensure that all individuals are accorded the same rights and dignity to which each and every person is entitled."

January 28, 2011

Global Fund: Misleading Corruption Report

by John S. James, Aidsnews.org

In the last few days hundreds of news stories have suggested that much or even most of the grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria have been lost to fraud. Most of the recent stories come from an Associated Press article published January 23 (see link below). Because of these stories, Germany suspended its payments to the fund pending investigation.

This is surprising because the Global Fund has been well known to be very aggressive in preventing or rooting out fraud, and in getting back money misused or stolen. And the issues matter because the Global Fund provides HIV or TB treatment to about 10 million people in poor countries, and malaria prevention to over 100 million -- most of whom would not otherwise get care.

Concerning the last few days' news, keep in mind:

(1) Almost all of the corruption information in the glut of stories in the last few days was discovered by the Global Fund itself, and published over a month ago (see the link below). The AP report and the hundreds of copycat stories in the last few days have echoed old information.

(2) The widely agreed figure of losses shown so far is just over $34 million (including "unsupported" expenses, which can be missing paperwork instead of corruption). This is serious, since money lost will result in unnecessary deaths. However, this represents about 0.3% of the money given out by the Global Fund, which appears to compare well with similar programs -- or with Washington, Wall Street, Europe, or anywhere else.

(3) If donors use these stories as an excuse to stop contributing to global health, millions of people will die as a result.

The Global Fund has done much better than other organizations in rooting out corruption, and is now being blamed for its own success in bringing problems to light.

Why the timing? Why a surge of hundreds of news stories in major media in 5 days, breathless with scandal but with little information except what the Global Fund itself published more than a month ago? Is it only coincidence that the right-wing plutocracy has chosen this time for a major worldwide assault against the poor and the middle class?

References

Obama Barraged By Pot Questions For Upcoming YouTube Town Hall

Huffington Post: "President Barack Obama plans to take questions from YouTube viewers Thursday afternoon, and for the third time in as many years, the overwhelmingly most popular query involves the legalization of marijuana.

"Of the top 100 most popular questions as rated by YouTube users, 99 are about the drug war or pot. Of the next one hundred, 99 are again about drug policy. Somehow, two questions about clean energy made their way into the top 200. ...

"The major drug-policy reform organizations say they have had little to do with the popularity of the pot questions and that it has largely been a 'grassroots' response. The top question is from an official associated with the group Law Enforcement Against Prohibition, but the second- and third-most popular, judging by their YouTube pages, are clearly not connected to a mainstream advocacy group."

HIV Lipo Drug Egrifta Now Available; Financial Assistance Programs Open

POZ: "Egrifta (tesamorelin), the lipodystrophy treatment approved by the U.S. Food and Drug Administration (FDA) late last year, is now officially available to people living with HIV and their health care providers, according to announcements from EMD Serono. To expedite prescriptions and reimbursement, the company also described various services—including patient assistance and co-pay programs—now open to HIV-positive patients who need the drug."

CDC Issues Interim Guidance to Providers About PrEP

POZ: "Aside from the modest level of protection found overall, the study also revealed that in people who reported taking Truvada at least 90 percent of the time, the reduction in infections was 73 percent.

"In the interim guidance, published January 27 in the Morbidity and Mortality Weekly Report (MMWR), the CDC warns, however, that there are important caveats to the study results—limitations that many community members pointed out when the data were first published."

January 25, 2011

City of Hope team develops "smart bomb" to neutralize HIV

Pasadena Star-News: "'What I like about it is the fact that this isn't just something that happened overnight. Rossi and his team have been working on strategies to stop HIV replicating using these very cutting-edge technologies based on RNA.'

"In the past, she said, 'they've made nice, steady, incremental progress.'

"'Now, in this study, they show the latest actually works really well in the context of a live animal - which is a huge step.'"

Australia clean-needle program keeping HIV at bay

Reuters: "'There has never been a significant, generalized outbreak of HIV among people who inject drugs in this country,' Topp said.

"'What our results show is that in a country where needle and syringe programs were introduced early and on a widespread basis, HIV transmission never became a problem among injectors.'

"Topp told Reuters Health in an email that, based on other research, the 1 percent HIV rate is true of all injection-drug users in Australia, and not only those who use the needle and syringe programs.

"By contrast, an estimated 16 percent of injection-drug users in the United States are living with HIV, while in Russia that figure is 37 percent."

January 24, 2011

Unexpected Find Opens Up New Front in Effort to Stop HIV

News Room - University of Rochester Medical Center: "'The first cells that HIV infects in the genital tract are non-dividing target cell types such as macrophages and resting T cells' said Kim. 'Current drugs were developed to be effective only when the infection has already moved beyond these cells. Perhaps we can use this information to help create a microbicide to stop the virus or limit its activity much earlier.'

"Kim notes that a compound that targets rNTP already exists. Cordycepin in an experimental compound, derived from wild mushrooms, that is currently being tested as an anti-cancer drug. The team plans to test similar compounds for anti-HIV activity.

"'This significant breakthrough was unappreciated prior to our paper. We are now exploiting new anti-HIV drugs jointly based on this novel approach that are essentially not toxic and that can be used to treat and prevent HIV infections,' said Schinazi, who has developed several of the drugs currently used to treat HIV patients."

January 23, 2011

Federal Research Center Will Help Develop Medicines

NYTimes.com: "The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines."

January 21, 2011

Free online tool may help doctors make treatment decisions for HIV-positive patients with drug resistance

Aidsmap: "UK investigators have developed an online resource that can help doctors select the most effective combination of anti-HIV drugs for patients with extensive experience of antiretroviral therapy. Evaluated in two studies published in the January edition of AIDS Patient Care and STDs, suggestions made by the tool led to doctors changing their initial treatment decision in a third of cases. Physicians found the resource easy to use, and the majority said that they would consider using it in the future.

"An updated version of the resource, the HIV Treatment Response Prediction System (HIV-TRePS), is now freely available on the internet, and is based on a computer model that includes information gathered from 65,000 HIV-positive patients across the world."

January 20, 2011

ADAPs with Waiting Lists (5,387 individuals in 10 states*, as of January 13, 2011) (NASTAD)

NATAP, from NASTAD: "ADAPs with Waiting Lists (5,387 individuals in 10 states*, as of January 13, 2011) (NASTAD)
 
"As of January 13, 2011, there are 5,387 individuals on ADAP waiting lists in ten (10) states. From NASTAD
 
"ADAPs with Waiting Lists (5,387 individuals in 10 states*, as of January 13, 2011)
 
Arkansas: 19 individuals
Florida: 2,816 individuals
Georgia: 873 individuals
Louisiana: 583 individuals**
Montana: 19 individuals
North Carolina: 100 individuals
Ohio: 438 individuals
South Carolina: 341 individuals
Virginia: 197 individuals
Wyoming: 1 individual ...

*As a result of ADAP emergency funding, Hawaii, Idaho, Iowa, Kentucky, South Dakota, and Utah eliminated their waiting lists.
**Louisiana has a capped enrollment on their program. This number is a representation of their current unmet need."

January 19, 2011

Repealing the Affordable Health Care Act means woes for people with HIV - Washington DC HIV and AIDS | Examiner.com

Repealing the Affordable Health Care Act means woes for people with HIV - Washington DC HIV and AIDS: "Repealing the act would mean:

* No expansion of Medicaid which would assist people with HIV/AIDS with life-saving healthcare
* No added provisions such as high-risk pools and insurance exchanges.  Those who have no coverage or have been previously denied coverage (perhaps because of a pre-existing condition) may be continuously denied and will not be able to comparison shop for private health-insurance plans.
* The Medicare Part D drug benefit coverage gap (otherwise known as the donut hole) stays put. People living with HIV/AIDS will not be able to depend on state AIDS Drug Assistance Programs (ADAP) to help cover the cost of prescription drugs."

Mutation of HIV-1 Genomes in a Clinical Population Treated with the Mutagenic Nucleoside KP1461

Mutation of HIV-1 Genomes in a Clinical Population Treated with the Mutagenic Nucleoside KP1461: "Overall, many RNA virus populations, including HIV, appear to exist near the brink of survivability [12], [13], as agents that disrupt the delicately balanced networks described above – by increasing the frequency of mutations in the HIV genome by as little as <2-fold – cause viral extinction in cell culture [14]–[17]. Similarly, small increases in viral mutation frequencies have been shown to be associated with population collapse in other viral systems, including Vesicular Stomatitis, polio, Hepatitis C, Hantaan and foot-and-mouth disease [18]–[25].

"We are studying the use of first-in-class nucleotide analogs that are incorporated by reverse transcriptase without leading to chain termination, yet base pair ambiguously and thus cause mutations, with the goal of eventually pushing the viral quasispecies beyond the brink of survivability in vivo. We term this approach to HIV therapy as “viral decay acceleration” (VDA)."

Stroke rate is climbing in HIV-positive people

latimes.com: "They reported in the online edition of the journal Neurology that, in the general population, the incidence of stroke fell 7%, from 998,739 cases in the first year of the study to 926,997 cases in the final year. During the same time period, however, the incidence of stroke among HIV-positive people rose about 60%, from 888 cases to 1,425. Moreover, all of the increase was in ischemic stroke -- strokes caused by blood clots in the brain -- and none in strokes caused by bleeding."

U.S. study finds 129 million have health conditions

Reuters: "As many as 129 million Americans under age 65 have health problems that could hurt their ability to obtain health insurance or force them to pay higher premiums, a U.S. government study said on Tuesday."

New research examines how HIV infections occur on the molecular level

EurekAlert!: "The UK's National Physical Laboratory (NPL) with the University of Edinburgh and IBM's TJ Watson Research Center have published new research about the structure of an HIV-1 protein that could help to develop new drugs to stop the virus infecting healthy cells.

"The research provides a new insight into how the changes in structure of a small part of an HIV protein (a membrane proximal peptide) may alter the infection of the virus into healthy cells. The team was able to observe key changes in this part of the protein implicated in the early stages of the infection by using a combination of powerful experimental and computational tools. This is the first attempt to demonstrate that the inducible binding of the peptide with membrane-like surfaces can serve as a responsive molecular anchor underpinning HIV fusion to target cells. ...

"The team's journal article detailing this research was selected as the featured article in the January 2011 issue of the journal Physical Chemistry Chemical Physics – the Royal Society of Chemistry's premier forum for physical chemistry research."

January 17, 2011

Women Might Have More Favorable Blood Levels of Some HIV Drugs

POZ: "Mona Loutfy, MD, one of the study’s authors, reported that she and her colleagues found that the average minimum concentrations (Cmin) of at least two drugs—Viramune and Kaletra—were significantly higher than what has been found in previous studies in the general population, while minimum concentrations were lower than average in women taking Reyataz or Sustiva. The primary concern about blood levels is keeping them within a “therapeutic” range, whereby there is enough drug present to shut down HIV repliction almost entirely, but not so much that it increases the risk of side effects. The authors suggest, however, than maintaining a higher than average Cmin level, even within this therapeutic range, might confer a treatment advantage.

"Loutfy’s team also found, contrary to expectation, that the maximal concentrations (Cmax) of all four drugs was slightly lower than average in their study participants. A lower Cmax would, theoretically, predict fewer and less severe side effects in the women."

New Treatment Guidelines Published

January 10, 2011

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents

What’s New in the Guidelines?

Key changes made to update the December 1, 2009, version of the guidelines are summarized below. Throughout the revised guidelines, significant updates are highlighted and fully discussed.

Introduction

The Panel emphasizes its recognition of the importance of clinical research in generating evidence to address unanswered questions related to the optimal safety and efficacy of antiretroviral therapy (ART). The Panel encourages both the development of protocols and patient participation in well-designed, Institutional Review Board (IRB)-approved clinical trials.

CD4 T-cell Count

The Panel recognizes that changes in CD4 cell count are seldom used in decision for ART changes in a patient on a suppressive ART regimen whose CD4 count is well above the threshold for opportunistic infection risk. In such patients, the Panel recommends that the CD4 count may be monitored less frequently, for example every 6 to 12 months (instead of every 3 to 6 months), unless there are changes in the patient’s clinical status, such as new HIVassociated clinical symptoms or initiation of treatment with interferon, corticosteroids, or anti-neoplastic agents (CIII).

Viral Load Testing

The Panel recognizes that low-level positive viral load results (typically <200 copies/mL) have been commonly reported with some viral load assays. For the purpose of patient monitoring, the Panel defines virologic failure as a confirmed viral load >200 copies/mL, which eliminates most cases of viremia caused by isolated blips or assay variability.

Drug-Resistance Testing

The Panel provides more specific recommendations on when to use genotypic testing to detect resistance to integrase strand transfer inhibitors (INSTIs).
• Because standard genotypic drug-resistance testing involves testing for mutations in the reverse transcriptase (RT) and protease (PR) genes, if transmitted INSTI resistance is a concern, providers may wish to supplement standard genotypic resistance testing with genotypic testing for resistance to this class of drugs (CIII).
• In persons failing INSTI-based regimens, genotypic testing for INSTI resistance should be considered to determine whether to include a drug from this class in subsequent regimens (BIII).

What to Start: Initial Combination Regimens for the Antiretroviral-Naïve Patient

Changes to the “What to Start” recommendations include the following:

• A regimen consisting of maraviroc (MVC) + zidovudine/lamivudine (ZDV/3TC) is now listed as an “Acceptable Regimen” because FDA approval of MVC for use in ART-naïve patients was based on the results of a randomized controlled trial using this regimen (CI).
• “MVC + tenofovir/emtricitabine (TDF/FTC)” and “MVC + abacavir (ABC)/3TC” have been added as “Regimens that may be acceptable but more definitive data are needed” (CIII).
• In response to a recent change to the Invirase® product label based on findings from a healthy volunteer study that reported significant PR and QT interval prolongations, ritonavir-boosted saquinavir (SQV/r)-based regimens have been moved from “Alternative PI-based Regimens” to “Regimens that are Acceptable but Should be Used with Caution.”

Hepatitis B (HBV)/HIV Coinfection

This section has been revised to provide more specific recommendations for management of HIV patients coinfected with HBV, including recommendations for patients with 3TC/FTC-resistant HBV infection and for patients who cannot tolerate TDF-based regimens.

Mycobacterium Tuberculosis Disease with HIV Coinfection

Based on recent randomized controlled trials showing survival and clinical benefits of starting ART earlier in treatment-naïve patients with active tuberculosis (TB) disease, the Panel provides the following recommendations on when to start ART in patients who are receiving treatment for active TB but are not yet on ART.
• All HIV-infected patients with diagnosed active TB should be treated with ART (AI).
• For patients with CD4 count <200 cells/mm3, ART should be initiated within 2–4 weeks of starting TB treatment (AI). • For patients with CD4 count 200–500 cells/mm3, the Panel recommends initiating ART within 2–4 weeks, or at least by 8 weeks after commencement of TB therapy (AIII). • For patients with CD4 count >500 cells/mm3, most panel members also recommend starting ART within 8 weeks of TB therapy (BIII).

Adverse Effects of Antiretroviral Agents

A new table format provides clinicians with a list of the most common and/or severe known antiretroviral (ARV)-associated adverse events listed by ARV drug class.

Additional Updates

The following sections and their relevant tables have also been updated:
• Coreceptor Tropism Assays
• Treatment Goals
• Initiating Antiretroviral Therapy in Treatment-Naïve Patients
• What Not to Use
• Virologic and Immunologic Failure (previously titled “Management of Patients with Antiretroviral Treatment Failure”)
• Regimen Simplification
• Exposure-Response Relationship and Therapeutic Drug Monitoring for Antiretroviral Agents
• Acute HIV Infection
• HIV and Illicit Drug Users (with new Table)
• HIV-2 Infection
• Drug Interactions (and Tables)
• Drug Characteristics Tables (Appendices)

January 16, 2011

Distribution of Antiretroviral Treatment Through Self-Forming Groups of Patients in Tete Province, Mozambique

JAIDS Journal of Acquired Immune Deficiency Syndromes: "Discussion: The Community ART Group model was initiated by patients to improve access, patient retention, and decongest health services. Early outcomes are highly satisfactory in terms of mortality and retention in care, lending support to such out-of-clinic approaches." [full text free]

Effects of in Utero Antiretroviral Exposure on Longitudinal Growth of HIV-Exposed Uninfected Infants in Botswana

JAIDS Journal of Acquired Immune Deficiency Syndromes: "Conclusions: Lower weights in HAART-exposed uninfected infants at birth were rapidly corrected during the first 6 months of life."

Identification of PD-1 as a Unique Marker for Failing Immune Reconstitution in HIV-1–Infected Patients on Treatment

JAIDS Journal of Acquired Immune Deficiency Syndromes: "In this study, we have analyzed PD-1 expression on CD4 and CD8 T cells in patients with poor immune reconstitution despite successful highly active antiretroviral therapy. We found that T cells of such patients express significantly higher levels of PD-1 than patients who had normal recovery of CD4 cells after treatment. In contrast, failing immune reconstitution was not associated with the expression of activation markers, indicating that PD-1 is a unique marker for failing immune reconstitution despite viral suppression."

January 10, 2011

Lipitor and Crestor Are Better Than Pravachol for HIV Treatment-Related Cholesterol Problems

POZ: "Lipitor (atorvastatin) and Crestor (rosuvastatin)—two drugs in the statin family—were about twice as likely as the statin Pravachol (pravastatin) to help HIV-positive people get their cholesterol and triglyceride levels within the desired range. These data were published online December 28 in Clinical Infectious Diseases."

January 9, 2011

New Study in San Francisco Aims to Improve HIV Care for Aging Population

POZ: "Researchers at the University of California in San Francisco (UCSF) have launched a study to discover the best comprehensive care methods for people living with HIV as they get older. In a news article by the university about the project, the study’s leaders explain they will be integrating the expertise of specialists in geriatric medicine with that of infectious disease experts to address the fact that HIV-positive people are experiencing age-related problems at a younger age than HIV-negative people."

Changes in Cerebral Function Parameters in HIV Type 1-Infected Subjects Switching to Darunavir/Ritonavir Either as Monotherapy or with Nucleoside ...

AIDS Research and Human Retroviruses:

Clinical Evaluation of the Potential Utility of Computational Modeling as an HIV Treatment Selection Tool by Physicians with Considerable HIV Experien

AIDS Patient Care and STDs - 25(1):29: "The HIV Resistance Response Database Initiative (RDI), which comprises a small research team in the United Kingdom and collaborating clinical centers in more than 15 countries, has used antiretroviral treatment and response data from thousands of patients around the world to develop computational models that are highly predictive of virologic response. ... Most physicians found the system easy to use and understand. All but one indicated they would use the system if it were available, particularly for highly treatment-experienced cases with challenging resistance profiles. Despite limitations, the first clinical evaluation of this approach by physicians with substantial HIV-experience suggests that it has the potential to deliver clinical and economic benefits."

Association of Age and Comorbidity with Physical Function in HIV-Infected and Uninfected Patients: Results from the Veterans Aging Cohort Study

AIDS Patient Care and STDs - 25(1):13: "A 50-year-old HIV-infected subject with chronic pulmonary disease had the equivalent level of function as a 68.1-year-old uninfected subject with chronic pulmonary disease. We conclude that age-associated comorbidity affects physical function in HIV-infected patients, and may modify the effect of aging. Longitudinal research with markers of disease severity is needed to investigate loss of physical function with aging, and to develop age-specific HIV care guidelines"

Flu vaccine recommendations for patients with HIV are 'justified'; vaccination encouraged

Aidsmap: "Recommendations that patients with HIV should be vaccinated against influenza “are justified,” according to an editorial in the January 1st edition of Clinical Infectious Diseases, and the use of the vaccine “should be encouraged.”"

January 6, 2011

California: Study Into HIV "Cure" Seeks Volunteers

The Body: "San Francisco researchers led by Dr. Jacob Lalezari are looking for HIV-positive volunteers to participate in a groundbreaking study that uses gene therapy to modify patients' immune systems.

"The study is based on work conducted in Germany on an HIV-positive man treated for leukemia. In 2007, the man received a bone marrow transplant from a donor with a rare genetic mutation that eliminates the CCR5 protein from the immune system. Without CCR5, HIV is unable to enter and infect T-cells. Three years after the transplant, HIV is undetectable in the patient.

"Lalezari, medical director at Quest Clinical Research and assistant clinical professor of medicine at the University of California-San Francisco, and his team are exploring a less invasive approach. Rather than undergo a costly and painful bone marrow transplant, volunteers will have their blood filtered to extract immune cells. Those cells will then be treated with a zinc finger nuclease that will remove the gene that produces the CCR5 protein. Following cultivation for about three months, a large dose of treated immune cells will be re-infused in the originating patient in the hope they "take root" and replace vulnerable cells.

"The treatment is expected to be painless and carry a relatively low risk of side effects."

Impact of flu vaccine opt-out is being seen as A(H1N1) returns to Europe

The Medical News: "As the UK and a number of European countries are now experiencing epidemics of influenza, including A(H1N1) which was the 2009 pandemic virus, the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) warns that the consequences of non-vaccination could emerge as a new flu emergency and are calling for greater efforts to encourage vaccination, not only for at risk groups but also health care workers."

Comment: It's not too late to get your annual flu vaccination.

January 5, 2011

Return of the "Death Panel" Myth is a "Travesty," Says Dr. Atul Gawande

Democracy Now: "DR. ATUL GAWANDE: Well, this change, which is to remove provisions that would have allowed for doctors to have additional payments to have end-of-life discussions with their patients, is an example of the mistake that repeal represents as a whole. End-of-life discussions are not death panels. But you say it over and over again, you brand it over and over again, and you begin to define what the meaning is of a major policy that’s passed. Being able to provide funding for discussions that have been shown to have a huge difference in improving the quality of life patients have and, in a recent study published in the New England Journal, also generated longer life for patients by helping them make better decisions about when to stop therapies that have become harmful to them, like that fourth round of chemotherapy and so on, those kinds of studies indicate we need more, longer and better discussions with doctors, overall. Repeal is a major mistake. Our choices are stalemate on making any kind of progress on healthcare at a time that the costs are going to be disastrous for our country over the next decade and at a time when more and more Americans are simply without health insurance.

"AMY GOODMAN: Well, let’s talk about what these end-of-life discussions are about. You wrote a very moving piece and also, I think, surprising piece called "Letting Go: What Should Medicine Do When It Can’t Save Your Life?" It appeared in The New Yorker magazine in August. You looked at a number of cases of people at the end of life, and you also looked at studies, like the Aetna study. You looked at La Crosse, Wisconsin. You looked at what happens when people start talking about the end of life."

Support for Winnipeg HIV lab faltered early, documents show

The Vancouver Sun: "Canada's chief public health officer decided to scrap plans to build a pilot HIV vaccine production facility more than six months before he told any of the four organizations vying for the project."

An Antiretroviral/Zinc Combination Gel Provides 24 Hours of Complete Protection against Vaginal SHIV Infection in Macaques

PLoS ONE: "Combination microbicide gels containing 14 mM zinc acetate dihydrate and 50 µM MIV-150 afforded full protection (21 of 21 animals) for up to 24 h after 2 weeks of daily application. Partial protection was achieved with the MIV-150 gel (56% of control at 8 h after last application, 11% at 24 h), while the zinc acetate gel afforded more pronounced protection (67% at 8–24 h). Marked protection persisted when the zinc acetate or MIV-150/zinc acetate gels were applied every other day for 4 weeks prior to challenge 24 h after the last gel was administered (11 of 14 protected). More MIV-150 was associated with cervical tissue 8 h after daily dosing of MIV-150/zinc acetate versus MIV-150, while comparable MIV-150 levels were associated with vaginal tissues and at 24 h."

The Price of Repealing the Affordable Care Act

HealthCare.gov: "As a result of the Affordable Care Act, families will soon be free from the constant worry that they will not be able to get health care when they need it the most. But repealing the law would strip Americans of this new freedom and take us back to the days when big insurance companies had the power to decide what care residents of the United States could receive—allowing them to once again deny coverage to children with pre-existing conditions, cancel coverage when people get sick, and place limits on the amount of care people can get, even if they need it. What’s more, without the law, insurance companies could overcharge for insurance just to boost their profits, or use fine print to deny medical treatments that are covered under people’s policies.

"In addition, repealing the law would add at least a trillion dollars to the deficit ...

* Over 1.2 million young adults would lose their insurance coverage through their parents’ health plans, sometimes just after they finish school and as they are looking for a job. Families across the United States would lose the peace of mind the Affordable Care Act provides by making sure that young adults can stay on their parents plan to age 26 if they do not have coverage of their own.

* Over 165 million residents of the United States with private insurance coverage would suddenly find themselves vulnerable again to having lifetime limits placed on how much insurance companies will spend on their health care.

* Insurance companies would once again be allowed cut off someone’s coverage unexpectedly when they are in an accident or become sick because of a simple mistake on an application. This would leave 15.9 million people in the United States at risk of losing their insurance at the moment they need it most, as one of the worst abuses of the insurance industry would become legal again.

* Over 165 million residents of the United States would not know if they are receiving value for their health insurance premium dollars, as insurers in state would no longer be required to spend at least 80 to 85 percent of premium dollars on health care rather than CEO salaries, bonuses, and corporate profits.

* New insurance plans would no longer be required to cover recommended preventive services, like mammograms and flu shots, without cost sharing, nor would they have to guarantee enrollees the right to choose any available primary care provider in the network or see an OB-GYN without a referral.

* 44.1 million seniors in the United States who have Medicare coverage would be forced to pay a co-pay to receive important preventive services, like mammograms and colonoscopies.

* Medicare would no longer pay for an annual check-up visit, so 44.1 million seniors in the United States who have Medicare coverage would have to pay extra if they want to stay healthy by getting check-ups regularly." [partial list]