23 JULY 2010, VOLUME 11, ISSUE 26
The Weekly NewsDigest is a compilation of HIV prevention research media coverage and relevant science in peer-reviewed journals; material on other reproductive health issues; and matters of policy and politics relevant to HIV prevention research, development and advocacy.
Its purpose is to raise awareness around the range of opinions and information about HIV prevention research disseminated in the press and scientific journals and provide a neutral, objective basis for decision-making and evidence-based advocacy.
 PUBLISHED RESEARCH
UPDATES AND ANNOUNCEMENTS
23 JULY 2010, VOLUME 11, ISSUE 26
Coverage of the CAPRISA 004 trial results: 19-22 July
Editor's Note: FHI provided this special compilation of media coverage, articles, and public statements during the period 19-22 July that were specifically related to release at the Conference of the results from the CAPRISA 004 trial of the 1% vaginal gel formulation of tenofovir.
19 July
20 July
21 July
22 July
Public Statements
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IAC: As HAART use went up, new infections fell
After the introduction of highly active antiretroviral therapy (HAART) for people living with HIV infection, the number of patients being treated grew five-fold in one Canadian province, but the number of new cases has been cut in half. Between 1996 and 2009, the number of patients receiving combination HAART therapy increased from 837 individuals to 5,413 (P=0.002), according to Julio Montaner, MD, of the British Columbia Centre for Excellence in HIV/AIDS in Vancouver, writing online in The Lancet. During the same time period, the number of new HIV diagnoses tumbled from 702 a year to 338 -- a 52% decrease (P=0.001). "The overall correlation between number of individuals on HAART and number of new HIV diagnoses per year was -0.89 (P<0.0001)," Montaner observed in his paper, published in conjunction with the International AIDS Conference here.
To read the full article, see: Montaner JSG, Lima VD, Barrios R, et al. Association of highly active antiretroviral therapy coverage, population viral load, and yearly new HIV diagnoses in British Columbia, Canada: a population-based study. The Lancet 18 July 2010.
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Many forks loom in road to AIDS vaccine
AIDS experts and advocates gathering in Vienna this weekend for a conference on the pandemic will hear about progress in protecting people from the deadly virus using drugs, and ways to affect behavior. No breakthrough news is expected on a vaccine. But researchers are more hopeful than they have been in years that it may be possible. They just have to choose the best path to pursue. "There has been a renaissance in AIDS vaccines," says Dr. Seth Berkley, president of the International AIDS Vaccine Initiative. Two studies published in the past year have greatly raised hopes. In one published last September, a combination of two older vaccines lowered the infection rate by about a third after three years among 16,000 ordinary Thai volunteers. In a second study, published earlier this month, researchers discovered human antibodies that can protect against a wide range of AIDS viruses.
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Global: A radical new UNAIDS treatment strategy
UNAIDS has launched a simpler, more cost-effective approach to HIV treatment, aimed at simultaneously achieving two holy grails of the AIDS response: drastic reductions in AIDS-related deaths and new HIV infections. The approach, dubbed "Treatment 2.0", aims to drastically scale up testing and treatment using current best practices and future innovations in antiretroviral (ARV) drugs and diagnostics. The prevention benefits of extending treatment to all those in need of it are based on mounting evidence that people on ARV treatment are much less likely to transmit the virus. UNAIDS estimates that successful implementation of Treatment 2.0 could avert 10 million deaths by 2025, and reduce new infections by one-third.
A report on the new strategy has been released ahead of the International AIDS Conference, starting on 18 July in Vienna, where one of the hot topics will be why most countries will fail to meet the goals of universal access to HIV prevention, treatment and care by the December 2010 deadline. Worrying indications that international financial support for the AIDS response is flagging will also be debated, but UNAIDS director Michel Sidibe is pitching the Treatment 2.0 approach as offering a potential solution to both concerns.
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HIV's holy grail: Hopeful talk of a cure for AIDS
Can AIDS be cured? It has long been a taboo to use the C-word when discussing the response to the pandemic, but scientists at the International AIDS Conference in Vienna are seriously discussing the idea that the human immunodeficiency virus can be eliminated from the body, or at least battered into quasi-permanent remission. "Vienna will not be the conference to announce a cure. But we should not continue to accept that HIV is a disease which commits patients to life-long treatment," said Sharon Lewin, a physician in the infectious diseases unit of the Alfred Hospital in Melbourne, Australia. While much effort has been invested in getting people with HIV-AIDS on a course of treatment, antiretroviral drugs essentially have to be taken for life. If they are stopped, illness returns with a vengeance, meaning that the cost of controlling the epidemic is astronomical, while the cost of non-treatment is even higher -- a Catch-22 of global proportions.
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Drugs, microbicide gel, money top issues at AIDS meet
A global AIDS forum was getting underway here on Sunday, with major announcements expected over six days on the drugs that have turned HIV from killer to a chronic but manageable disease, and the quest for a virus-thwarting gel. Overshadowing the long-awaited meeting, though, are renewed worries on raising billions of dollars to help sustain the war on a nearly 30-year-old epidemic. Thousands of scientists, policymakers, grassroots campaigners and activists flooded into the Vienna congress centre for pre-conference seminars ahead of a ceremonial start in the evening.
The global confab is set to catapult anti-HIV drugs, known as antiretroviral therapy (ART), to a new level of importance. Around five million people around the world are alive today thanks to this therapy, which emerged in 1996 and initially was so expensive that it was restricted to rich nations. In one of the first presentations, a panel of US scientists issued recommendations on Sunday for earlier use of ART, saying patients treated before their immune system is badly damaged by the human immunodeficiency virus (HIV) faced a lesser risk of death and sickness.
On Tuesday, researchers unveil the results from a South African trial where women volunteers tested a prototype anti-HIV gel. The search for a vaginal microbicide has been one of the most daunting challenges in the history of AIDS. The goal is to provide women, especially those in sub-Saharan Africa, where two-thirds of the world's HIV infections occur, with a means other than the condom to protect themselves against the pathogen.
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Preliminary results suggest good safety and adherence profile for PrEP
People taking either daily or intermittent pre-exposure prophylaxis (PrEP) to prevent HIV infection had few side effects and relatively good adherence to these regimens, according to data presented Monday, July 19, at the XVIII International AIDS Conference (IAC) being held July 18 to 23 in Vienna.
Experts hold great hope for PrEP as an HIV prevention strategy. Currently a number of PrEP trials are ongoing, testing either Viread (tenofovir) or Truvada (tenofovir plus emtricitabine) in a variety of dosing strategies. Basic safety and adherence data are now beginning to roll in, with efficacy data expected by the end of 2010.
At the IAC, researchers in Kenya and the United States offered preliminary results from a trial that is comparing either daily Truvada PrEP or intermittent Truvada PrEP with a placebo. PrEP is being studies in three risk-groups: men who have sex with men (MSM), female sex workers (FSW) and in HIV-negative heterosexuals with an HIV-positive partner (serodiscordant couples). Thus far, early data are available on 67 MSM, 5 FSW and 32 serodiscordant couples. Those taking either Truvada or a placebo intermittently were asked to take their study drugs on Mondays and Fridays and within two hours after having insertive sex. Adherence was measured using both self-reporting and an electronic memory cap monitor on pill bottles. Based on these preliminary data, both PrEP strategies appear to be safe and well tolerated.
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Africa: Better prevention needed for HIV-exposed babies
About half the babies exposed to HIV may not be getting the antiretroviral (ARV) drugs they need to be born HIV-free and stay that way, say the findings of a four-country study published in the Journal of the American Medical Association (JAMA). The study, conducted in Cameroon, Cote d'Ivoire, South Africa and Zambia, found that only 51 percent of HIV-exposed infants had received a single dose of nevirapine before and after birth, the basic tool in prevention of mother-to-child HIV transmission (PMTCT).
The major problem was non-adherence among expecting mothers - more than a quarter did not take the nevirapine tablet at the onset of labour, and health workers also sometimes failed to dispense the drug or check that mothers had taken it. According to UNAIDS, using nevirapine as part of PMTCT services can lower a baby's chances of contracting HIV by more than 40 percent. The study, partly based on data collected from umbilical cord blood samples, also found that many women did not make use of PMTCT services because they or health workers did not know their HIV status - either due to a failure to test or collect the results.
To read the full article on the study, see: Stringer EM, Ekouevi DK, Coetzee D, Tih PM, et al. Coverage of nevirapine-based services to prevent mother-to-child HIV transmission in 4 African countries. JAMA. 2010;304(3):293-302. See also story in MedPage Today: "IAC: HIV prevention misses half of mothers, kids".
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Global: The big five at AIDS 2010
"Rights Here, Right Now" is the theme of the 18th International AIDS Conference, also known as "AIDS 2010", opening on 18 July in Vienna, Austria. Around 25,000 policy-makers, programme implementers, scientists, community workers, activists and people living with HIV will gather to discuss the latest developments in the field of HIV/AIDS. IRIN/PlusNews has listed some of the issues likely to top the list during the five-day event.
Universal Access -- Under different circumstances, the champagne would be on ice as the December 2010 deadline for universal access to HIV prevention, treatment and care approaches; instead, the HIV/AIDS fraternity at AIDS 2010 will be going back to the drawing board, as pitifully few countries have achieved the universal access targets set by the United Nations General Assembly Special Session on HIV/AIDS in 2005.
Participants will look for lessons to be learned. Prevention, in particular, remains a huge challenge: for every two people put on antiretroviral (ARV) treatment there are five new infections. Discussions on new strategies are likely to focus on HIV prevention in high-risk groups like sex workers and mobile populations.
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J&J AIDS drug shows promise, raises questions
Two pivotal trials of a Johnson & Johnson (JNJ.N) experimental HIV drug found it worked as well as an existing drug, with fewer side effects but also with nearly twice as many patients failing to respond to treatment. The drug, rilpivirine or TMC278, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed for use in combination therapy for treating the human immunodeficiency virus (HIV) that causes AIDS. J&J already has a deal with U.S. biotech company Gilead Sciences (GILD.O) to develop a single pill combining rilpivirine with Truvada, a drug containing Gilead's tenofovir and emtricitabine.
Gilead currently sells a once-daily pill, Atripla, that combines Truvada with Sustiva, an older NNRTI made by Bristol-Myers Squibb (BMY.N). But it earns no profit on the Bristol drug, known generically as efavirenz, and all of the Atripla components lose patent protection in the next few years. Under the deal with J&J, Gilead would keep up to 30 percent of TMC278 sales. J&J said a combined analysis of its trials found that, after a year of treatment, 84.3 percent of HIV patients treated with TMC278 and Truvada achieved undetectable levels of the virus compared to 82.3 percent of patients treated with Atripla or similar drugs.
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Microbicides and circumcision could achieve modest cuts in HIV infections in Africa
Three mathematical models presented at the Eighteenth International AIDS Conference in Vienna have found that circumcision and a microbicide, used separately or together, could produce modest reductions in HIV incidence. The models, by Andrew Cox of the London School of Hygiene and Tropical Medicine and Hiam Chemaitelly of Weill Cornell Medical College in Qatar, broadly agreed that a realistic level of microbicide and circumcision adoption would produce an approximately 20% reduction in new HIV infections within 15 to 20 years. Adding comprehensive antiretroviral therapy (ART) into this mix would reduce new infections considerably more. A third model, by Geoffrey Garnett of Imperial College in London, was cited by Bill Gates in his conference talk on Monday. This showed that adding in microbicides and pre-exposure prophylaxis (PrEP) to currently available prevention interventions -- excluding ART -- would reduce HIV infections by an additional 15 to 18%.
Andrew Cox's model used as its baseline the current situation in Uganda and forecast changes for the next 15 years. He initially assumed a rise in the proportion of men in the population who were circumcised would rise from 18%, as it is now, to 48% over the next ten years, and then stay the same. He assumed that circumcision stopped six out of ten infections in men. For microbicides, he initially assumed an efficacy of 60% (rather on the high side for the microbicide in the CAPRISA study) that women would use them 80% of the time when they had them, and that they would be available to 30% of the population after ten years.
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Glaxo takes new AIDS drug into final-stage tests
GlaxoSmithKline and its partner Shionogi are progressing a new drug against HIV into final-stage clinical testing, ramping up competition in a class of AIDS drugs known as integrase inhibitors. The two drugmakers said on Wednesday they would be progressing the experimental medicine, S/GSK1349572, into Phase III clinical trials later this year, following promising results from two Phase IIb studies. The decision to advance the drug comes one day before the release of the keenly awaited mid-stage clinical trial results on the medicine at the International AIDS Conference in Vienna. Industry analysts believe '572 could reach the market in 2013, assuming it performs well in the next phase of testing.
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Bill Clinton on HIV/AIDS: much more needs to be done
Former President Bill Clinton addressed the 18th International AIDS Conference in Vienna Monday. He said while much progress has been made in the fight against the epidemic, much more remains to be done, including on human rights. Mr. Clinton was the keynote speaker at Monday's plenary session at AIDS 2010.
"This year's conference theme -- Rights Here, Right Now -- reminds us that health care should be a right for everyone, but isn't," he said. While progress has been made, he said, it is not the time to become complacent. "Notwithstanding the current economic difficulties, the evidence of the progress that has been made in the last few years is not an excuse to walk away from that right. It's an excuse to run toward it for all of us."
The former president expects the AIDS conference to produce -- what he calls --encouraging scientific news. That may include Tuesday's announcement about whether a microbicide called CAPRISA 004 works. Microbicide trials in the past have all failed to show any protection against HIV. But CAPRISA 004, a gel, is the first to contain antiretroviral drugs.
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Providing prevention for men who have sex with men could significantly reduce HIV infections in many countries
A mathematical model developed by the Bloomberg School of Public Health at Johns Hopkins University shows that developing effective 'combination prevention' programmes for men who have sex with men (MSM), including both biomedical and behavioural interventions, would significantly reduce the scale of the HIV epidemic in many countries.
In areas like Latin America, where the epidemic is mainly driven by sex between men, providing comprehensive prevention to MSM could cut overall HIV prevalence by almost 50%, a pre-conference organised by the Global forum for MSM and HIV heard. The findings, by researcher Chris Beyrer, were presented at the Be Heard! pre-conference for MSM attended by around 700 delegates -- see this report for more from the meeting.
Stephen Lewis, the former UN special envoy for HIV/AIDS in Africa, who also addressed the meeting, hailed the model as the first evidence hard enough to persuade reluctant politicians that they had to address the prevention needs of MSM in their countries.
Beyrer's model was made possible by the increasing number of prevalence surveys of HIV in MSM from a number of countries. A literature search, combined with proactive networking with key opinion leaders, unearthed data from 138 prevalence studies of HIV in MSM from 50 different countries, covering most areas of the world with the notable exceptions of most of the Middle East and central Asia. They reveal that, with two exceptions -- Namibia and South Africa -- HIV prevalence is higher in MSM than in the general population. In lower- and middle-income countries taken as a whole, MSM are 19 times more likely to have HIV than the general population, and 44 times more in developed countries.
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Global HIV Vaccine Enterprise releases overview of obstacles in HIV vaccine research
The Global HIV Vaccine Enterprise, a unique alliance of independent organizations dedicated to accelerating the development of a preventive HIV vaccine, has released a new overview of the major obstacles to developing the safe and effective vaccines that could one day help end the AIDS epidemic. The document, The Road to Prevention, also contains clear recommendations to accelerate HIV vaccine research and identifies opportunities to make the field more dynamic, collaborative and efficient moving forward.
"Since its creation, the collaborative efforts of Global HIV Vaccine Enterprise stakeholders have led to significant changes in how HIV vaccine research has been focused, organized and funded, and have helped produce major breakthroughs in the field," said Peter Piot, Director of the Institute for Global Health at Imperial College, London. "The Road to Prevention presents a timely overview of the biggest challenges we face now in translating those advances into real progress toward the development of safe and effective HIV vaccines." Among the issues addressed in the "The Road to Prevention" are the need to:
Build aggressively on recent laboratory and clinical trial advances; increase rapid data sharing among HIV vaccine researchers and between research efforts; expand efforts to attract new minds and new ideas to the HIV vaccine research endeavor; and broaden funding sources and increase funding levels for HIV vaccine research.
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Global: Funding pall hangs over AIDS 2010 conference
A chaotic protest against reduced funding for HIV delayed the opening of the International AIDS Conference, where money, or the lack of it, is likely to dominate proceedings. Dozens of activists stormed the stage of Vienna's Reed Messe Centre, holding a giant banner reading "No Retreat, Fund AIDS". The activists - among them HIV-positive people, NGO workers and sex workers - had earlier held a "die-in" at the conference venue to show the consequences of a global retreat in HIV funding.
According to a just-released report by the Kaiser Family Foundation and UNAIDS, in 2009, the Group of Eight (G8) nations, European Commission and other donor governments provided US$7.6 billion for AIDS efforts in developing nations, compared with US$7.7 billion in 2008. Donor countries have attributed the drop in contributions to the global economic crisis, but leading figures in the fight against HIV, say it is an excuse that rings hollow.
"[G8] leaders had no problem bailing out greedy Wall Street bankers and... a full 110 billion euros [US$142 billion] appeared from nowhere when the Greek economy faltered earlier this year, but the purse is always empty when it comes to global health," Julio Montaner, chair of the International AIDS Society, told delegates at the opening session. "It is a question of priorities."
The shortage of funds threatens to put a major kink in the latest plan by UNAIDS, "Treatment 2.0", which aims to drastically scale up testing and treatment. If successful, UNAIDS estimates it could avert 10 million deaths by 2025, and reduce new infections by a third.
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Cash rewards with counseling could help prevent STIs
Giving out cash can be an effective tool in combating sexually transmitted infections in rural Africa, according to a new study conducted jointly by researchers at the University of California, Berkeley, the Development Research Group at the World Bank and the Ifakara Health Institute in Tanzania. The study, presented at the International AIDS Conference in Vienna, Austria, found that people who were offered up to $60 each over 12 months to stay free of STIs had a 25 percent lower prevalence of those infections after a year compared to those who were not eligible for the money.
"For many of our study participants, $60 represented about one-fourth of their reported annual income, so it was a significant incentive," said study author Will Dow, UC Berkeley professor of health economics. "The question we tested is whether the cash reward was enough of an incentive to reduce risky behavior and better take advantage of available health services. Although we cannot directly measure risky behavior, the fact that disease prevalence decreased suggests that the incentives worked."
Dow teamed up with Damien de Walque, a senior economist at the World Bank, and Rose Nathan, a senior research scientist at the Ifakara Health Institute, to test the conditional cash transfer program, an increasingly popular concept in the public health field that essentially rewards desirable behavior with money.
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African men line up to lose their foreskins to prevent AIDS, studies show
At least 100,000 men in Africa have volunteered to be circumcised to lower their chances of catching HIV, four years after studies showing the procedure could prevent infections. More than 90,000 men have been circumcised in Kenya since October 2008, including 36,000 over 30 working days late last year, researchers from the African nation said at the International AIDS Conference in Vienna today. Kenya, where about 8.5 percent of people are infected with the AIDS-causing virus, plans to circumcise 80 percent of uncircumcised men age 15 to 49 to prevent more than 100,000 HIV infections over the next 10 years.
"When it comes to circumcision, I used to be a skeptic," Bill Gates, co-chairman of the Bill & Melinda Gates Foundation and co-founder of Microsoft Corp., said in a speech at the conference yesterday. "I was doubtful that a large number of men would sign up for it. I'm glad to say I was wrong. Wherever there are clinics available, men are volunteering to be circumcised in huge numbers, far more than I expected."
Three large African studies have shown that circumcision can lower heterosexual men's risk of infection by the AIDS-causing virus, HIV, by almost two-thirds. The World Health Organization says that HIV-infected men shouldn't be denied circumcision if requested, as long as there is no medical reason to avoid it.
In a separate study presented today, 14,000 men were circumcised in less than two years in a South African township, representing almost 40 percent of the community's population. That shows programs to offer the service to men in low-income areas can be effective and safe, researchers from the French National Agency for Research on AIDS and Viral Hepatitis said.
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Kenya makes strides in fight against HIV/AIDS
As the AIDS/HIVS 2010 conference takes place in Vienna, Austria, Kenya is among states that will receive praise for having made tremendous steps in its fight against HIV/AIDS. Kenya has particularly made great strides in increasing awareness about HIV/AIDS to halt new infections, preventing mother to child infections and increasing access of anti-retroviral drugs among people living with the disease. Currently, statistics indicate that approximately 1.5 million people live with HIV/AIDS in Kenya and 100, 000 new infections are recorded annually. However, the prevalence has declined from 13.4 percent in 2000 to its present level of about 6 percent. But reports show that despite the general decline in prevalence rates across the population, a sharp increase is being witnessed among specific groups like sex workers, drugs abusers and homosexuals. The government scaled up its fight against the disease in 2006 when it launched Kenya National HIV and AIDS Strategic Plan of 2006-2010. This plan had elaborate and specific ways in which the government and its partners would use to reduce HIV prevalence rates.
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Many false-positive HIV test results for those in AIDS vaccine trials
Almost half of HIV-negative people who participate in clinical trials for HIV vaccines end up testing positive on routine HIV tests -- even though they're not actually infected, a new study shows. The reason: They underwent what experts call "vaccine-induced seropositivity/reactivity" (VISP), meaning that they possess immune system antibodies to the virus but not the virus itself. That's an important distinction, since routine HIV screening looks for virus antibodies only. Experts pointed out that the results are not new or surprising, but simply underline the delicacies of conducting trials into HIV/AIDS.
"You need to make sure to use other forms of testing for HIV, for example, viral load or p24 antigen, not just HIV antibodies. And people who've been in trials need to know their antibody status by the end of the trial," said Dr. Michael Horberg, director of HIV/AIDS at Kaiser Permanente in Santa Clara, Calif. "If it is a false positive but they do not have HIV infection, that would be very important for them to know, especially if they do repeat testing as part of good preventive health."
But a positive test can still carry stigma as well as insurance repercussions, noted Dr. Jerome F. Levine, an infectious diseases specialist with Hackensack University Medical Center in New Jersey, adding that "trials have had trouble recruiting people for this very reason."
The findings are simultaneously being presented Sunday at the International AIDS Conference in Vienna and published in the July 21 issue of the Journal of the American Medical Association (JAMA).
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PUBLISHED RESEARCH
Special issue of JAMA on HIV/AIDS
Editor's Note: The Journal of the American Medical Association (JAMA) released a special theme issue on HIV/AIDS at http://jama.ama-assn.org/cgi/content/full/304/3/239. Links to articles of interest are included below.
Vaccine-induced HIV seropositivity/reactivity in noninfected HIV vaccine recipients
Cooper CJ, Metch B, Dragavon J, et al.
Coverage of nevirapine-based services to prevent mother-to-child HIV transmission in 4 African countries
Stringer EM, Ekouevi DK, Coetzee D, et al.
Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society -- USA Panel
Thompson MA, Aberg JA, Cahn P, et al.
Reframing HIV prevention in Sub-Saharan Africa using couple-centered approaches
Grabbe KL and Bunnell R
HIV study shines spotlight on women
Hampton T
Expanded HIV testing and trends in diagnoses of HIV infection -- District of Columbia, 2004-2008
Centers for Disease Control and Prevention (CDC)
Vaccine, please
Scurlock D
AIDS, sex, and culture: global politics and survival in Southern Africa
Pappas G
HIV infection: the basics
Steven LM, Lynm C, Glass RM
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Do systemic and genital tract tenofovir concentrations predict HIV seroconversion in the CAPRISA 004 tenofovir gel trial? (Abstract TUSS0503)
Background CAPRISA 004 is a two-arm, double-blind, randomized, placebo controlled trial assessing the effectiveness and safety of 1% tenofovir (TNF) gel in 889 women. 98 participants became HIV positive. This pharmacology study assesses whether the presence or absence of TNF is associated with HIV seroconversion in CAPRISA 004.
Methods TNF and tenofovir diphosphate (TNF-DP) exposure in blood, genital tract secretions, and vaginal and cervical tissue were measured in 50 HIV seroconvertors and compared to 40 HIV negative women who had high sexual frequency and high gel use. For HIV+ women, samples closest to estimated date of infection were selected. For women who remained HIV- for the entire duration of the trial, samples were obtained from a high-gel use visit (A) and an exit visit (B). TNF and TNF-DP concentrations were measured by validated LC/MS/MS methods. Data are expressed as median [IQR].
Results Age of HIV+ and HIV- subjects were 23(20-25) and 27(23-31)yrs. Samples from HIV+ women were obtained 15 (14-121) days after the estimated time of infection, and 5(3-8) days after gel use. Samples in HIV-women were obtained 3(2-6) or 5(3-8) days after reported gel use, for visit A and B respectively. TNF was detected in genital tract secretions in 36% of HIV+ and 83% of HIV- women. TNF was detected in blood in 9% of HIV+ and 30% of HIV- women. Tissue biopsies in HIV+ subjects were obtained 24(18-48) days after last reported gel use: TNF was detected in 20% of vaginal and 13% of cervical tissues: TNF-DP was detected in 16% of vaginal and 7% of cervical tissues.
Conclusions More HIV- women had detectable TNF concentrations compared to HIV+ women. Final unblinded TNF and TNF-DP data will be presented according to active or placebo randomization status.
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Safety of 1% tenofovir vaginal microbicide gel in South African women: results of the CAPRISA 004 trial (Abstract TUSS0504)
Background A microbicide is urgently needed, especially for women who cannot negotiate mutual monogamy and condom use. The CAPRISA 004 trial assessed the effectiveness and safety of candidate microbicide, 1% Tenofovir gel.
Methods We conducted this randomized, placebo-controlled trial among 18 to 40 year old urban (Durban) and rural (Vulindlela) women (n=889) followed for up to 30 months. Women were instructed to insert a dose of either 1% tenofovir or placebo gel within 12 hours prior to coitus and a second dose as soon as possible afterwards, but within 12 hours. Safety assessments included monthly pregnancy tests, quarterly pelvic exams, and blood draws at months 3, 12, 24 and study exit.
Results Women's average ages were 23.3 and 25.1 years, respectively at Vulindlela and Durban, and 93.5% and 96.4% of women were single respectively. A total of 4692 adverse events (AEs) were reported, including one death, 38 other serious AEs, and six fractures. No serious AEs were considered related to use of tenofovir gel. The most frequently reported AEs were influenza (436 patients), vaginal discharge (312 patients) and vaginal candidiasis (244 patients). We identified severe hypophosphatemia in 22 women (15 in Vulindlela and 7 in Durban). No moderate and one severe elevated creatinine level was identified. We identified 53 pregnancies, 34 in Vulindlela and 19 in Durban, with 4 and zero pre-term deliveries respectively. 283 women in Vulindlela and 29 women in Durban had vaginal discharge and 136 and 108 women respectively had vaginal candidiasis. There were nine social harm events in Vulindlela and three in Durban. Unblinded safety results are not yet available but will be presented at the meeting.
Conclusions There are no major differences between the communities in occurrence of adverse events or social harms. We will present conclusions based on unblinded data at the meeting.
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Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women
The CAPRISA 004 trial assessed effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n = 445) with placebo gel (n = 444) in sexually active, HIV-uninfected 18- to 40-year-old women in urban and rural KwaZulu-Natal, South Africa. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years, i.e., person time of study observation (38/680.6 women-years), compared to 9.1 per 100 women-years (60/660.7 women-years) in the placebo gel arm (incidence rate ratio = 0.61; P = 0.017). In high adherers (gel adherence >80%), HIV incidence was 54% lower (P = 0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50 to 80%) and low adherers (gel adherence <50%), the HIV incidence reduction was 38% and 28%, respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconverters. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.
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UPDATES AND ANNOUNCEMENTS
New edition of Guidelines for involving communities in HIV prevention research released at International AIDS Conference
The draft second edition of The Good Participatory Practice (GPP) Guidelines for Biomedical HIV Prevention Trials were released yesterday at the International AIDS Conference in Vienna by AVAC and UNAIDS. The GPP Guidelines aim to provide trial funders, sponsors, and implementers with systematic guidance on how to effectively work with a range of stakeholders as they design and conduct biomedical HIV prevention trials.
The guidelines were developed by AVAC and UNAIDS in consultation with a broad range of global stakeholders who have provided perspectives since the first edition was published in 2007. AVAC and UNAIDS are now seeking feedback on the draft second edition from those with interest and expertise in HIV prevention research until 31 October, after which the final second edition will be published.Visit AVAC's GPP web page for more information on these Guidelines and AVAC's GPP initiative.
Download The GPP Guidelines
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Report warns flat global funding for HIV prevention research may limit ability of researchers to move promising approaches forward
Following significant advances in vaccine and microbicide research, including results presented today of 39% efficacy in the CAPRISA 004 microbicide gel trial among women in South Africa, a new report released today warns that flat funding for HIV prevention research may limit researchers' ability to quickly move promising approaches forward. The report examines investment in HIV prevention research in 2009 and finds that the onset of a global recession did not immediately impact funding levels for biomedical HIV prevention research. Total funding remained stable at approximately US$1.165 billion for preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) and operations research related to male circumcision.
In the face of an economic crisis that has deeply affected the economies and public-sector budgets of HIV prevention research funders, level funding for HIV prevention is cause for cautious optimism. Yet much of the 2009 funding was likely reflective of resources committed when the global economy was far healthier. As current funding commitments come to an end, the concern will be whether funders will be able to renew commitments at existing funding levels. Furthermore, the report authors argue that flat funding of HIV prevention research could have serious consequences for the field as results from critical prevention trials move the research agenda forward. They warn that researchers could have insufficient resources to advance important opportunities to prevent HIV.
Advancing the Science in a Time of Fiscal Constraint: Funding for HIV Prevention Technologies in 2009, the sixth annual report from the HIV Vaccines and Microbicides Resource Tracking Working Group, was released today at the XVIII International AIDS Conference in Vienna, Austria. It documents investments in biomedical HIV prevention research from public, philanthropic and commercial sectors in 2009. HIV vaccines continued to receive the majority of funding, with a total of US$868 million, which was equal to 2008 funding levels. Investment in microbicides was US$236 million, a decline of 3 percent from 2008 levels. Funding for oral pre-exposure prophylaxis (PrEP) increased by 18 percent over 2008 levels to US$52 million.
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UNAIDS satellite explores paving the way towards virtual elimination of mother-to-child transmission of HIV
UNAIDS hosted a satellite at AIDS 2010 on preventing mother-to-child transmission of HIV 19 July. It was co-chaired by Antony Lake, Executive Director of UNICEF and Hiroki Nakatani, Assistant Director General of World Health Organization (WHO) and coordinated by Gottfried Hirnschall, Director of the HIV department (WHO). Opening remarks were delivered by Michel Sidibe, Executive Director of UNAIDS and Michel Kazatchkine, Executive Director of the Global Fund to Fight AIDS, TB and Malaria, and Ambassador Eric Goosby, United States Global AIDS Coordinator.
The call to eliminate mother-to-child transmission of HIV was first made by UNAIDS Executive Director Michel Sidibe and he has since been joined by leaders of nations, heads of multilateral, bilateral, regional and national bodies, presidents of foundations, members of civil society, and even captains of football teams in the FIFA 2010 World Cup.
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23 JULY 2010, VOLUME 11, ISSUE 26
Special coverage of AIDS 2010 Conference in Vienna
This issue of the Weekly News Digest is dedicated to the 18th International AIDS Conference -- "AIDS 2010" -- held in Vienna, Austria, from 18-23 July. Non-conference-related material that appeared in this same time period is being held for inclusion in next week's issue of the News Digest (Issue 27).
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