Press Release

HIV/AIDS Organizations Tell FDA and Gilead Sciences: Don’t Delay HIV Prevention for Gay and Bisexual Men and Transgender Women

New York, NY — Thirteen prominent U.S. HIV/AIDS organizations have issued an open letter to the U.S. Food and Drug Administration and Gilead Sciences calling for prompt regulatory review of pre-exposure prophylaxis (PrEP) for HIV prevention in gay and bisexual men and transgender women (men who have sex with men, or MSM). The letter urges FDA and Gilead to start the review process that could allow safe and appropriate approved PrEP use as a public health intervention, and not to delay review because of distinct questions about the safety and efficacy of PrEP in heterosexual populations. The letter is available online at: www.avac.org/letters/fda-gilead

Pre-exposure prophylaxis, or PrEP, is a new HIV prevention method in which an uninfected person takes a daily HIV medication to reduce HIV infection risk. Data from an international study released in November, 2010 called iPrEx found that men and transgender women who have sex with men who received a daily single-tablet dose of the HIV drugs tenofovir and emtricitabine along with condoms and safe sex counseling had an average of 42% fewer HIV infections than those who received condoms and counseling alone.

Advocates assert that the need for new HIV prevention strategies for MSM is urgent. The U.S. Centers for Disease Control (CDC) estimates that MSM account for more than half of all new HIV infections in the United States. CDC logged an estimated 34% increase in HIV infections in young gay men between 2006 and 2009, and a 48% HIV increase among young black/African American gay men over the same period.

“We desperately need new strategies and tools to reduce the rapidly increasing rates of HIV infection in black gay and bisexual men,” said Phill Wilson, executive director of the Black AIDS Institute. “We’ve had evidence of PrEP’s effectiveness in MSM for almost a year now. It’s time to use every tool at our disposal to reduce the 50,000 new HIV infections that occur each year in this country. Prompt FDA review will help ensure that appropriate guidelines for PrEP use are established that can reduce HIV infections and safeguard public health.”

Data on PrEP in heterosexuals raise important but unique questions that may require further study. Two major trials in Africa found that PrEP reduces HIV infection risk in heterosexual men and women substantially. But two other studies present conflicting information about how PrEP works in heterosexuals. Critical and necessary efforts to understand how PrEP interacts with hormonal contraception, or how PrEP may impact pregnancy, however, should not delay access to a potentially lifesaving form of HIV prevention for MSM.

Before the results of the heterosexual PrEP studies were announced, the FDA and Gilead Sciences, the maker of the drugs, were reported to be ready to move quickly to consider approval of PrEP for those MSM who could benefit from the approach. Recent signs indicate, however, that FDA review of PrEP for this population may not start until the agency acquires more data on PrEP among heterosexuals—despite the urgent need for new HIV prevention strategies for MSM, and the fact that PrEP data in MSM were announced nearly one year ago.

“The FDA and Gilead Sciences should move quickly to ensure a thorough review of PrEP for MSM now, while they both work simultaneously and swiftly to thoroughly address questions and concerns about PrEP among heterosexual populations,” said Mitchell Warren, executive director of AVAC “Prompt FDA review of PrEP in MSM is the right thing to do for public health. In the midst of a growing HIV epidemic, HIV prevention delayed is HIV prevention denied.”

 

Contact:
Kay Marshall, [email protected], +1-347-249-6375
Robert Reinhard, [email protected], +1-415-570-1010

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A PDF version of this document is available here.

Press Release

An Open Letter to the US Food and Drug Administration and Gilead Sciences

RE: Timing the Review and Approval of Pre-exposure Prophylaxis for HIV Prevention

We, the undersigned, are non-profit organizations and coalitions who support the development of and access to new safe and effective HIV prevention options in the United States and globally. Data from multiple clinical trials in different populations showing that antiretroviral drugs for HIV treatment can also prevent HIV infection have accumulated to the point where FDA approval decisions could be made for this intervention. The approval issues for the different populations are not identical. For the reasons outlined below, we urge the FDA and Gilead Sciences to reconsider plans to combine the approval for a prevention indication for both men who have sex with men, including transgender populations (MSM) and heterosexuals into a single filing. The combination could unnecessarily delay approval for MSM, the group at greatest risk of HIV infection in the United States.

FDA has a duty to move forward on beneficial products by setting out best terms of use, and, by law, to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.” This duty is what’s in question today.

Results from three large clinical trials show that oral pre-exposure prophylaxis (oral PrEP) has the potential to prevent new HIV infections. Last year the iPrEx trial found that daily TDF/FTC (marketed as Truvada by Gilead) along with standard prevention reduced HIV infection risk by 42% in at-risk gay/bisexual men and transgender women who have sex with men (MSM).

The results preceded release of important infection data for MSM in the U.S. The U.S. Centers for Disease Control (CDC) estimates that MSM account for more than half of all new HIV infections in the U. S. For many MSM the HIV risk is growing. CDC found an estimated 34% increase in HIV infections in young MSM between 2006 and 2009, and a 48% increase in HIV among young black/African American MSM over the same period. MSM represent a population with demonstrable need for effective prevention tools.

Two additional trials have shown that oral TDF/FTC (or TDF alone as in one of the trials) as PrEP also reduces HIV infection risk by 62-73% in at-risk heterosexual men and women. But a fourth study of oral TDF/FTC as PrEP, which was conducted in a population of heterosexual women, was stopped before its anticipated end date after an interim data review found equal numbers of infections in the experimental and placebo arms. More recently, the oversight board of an ongoing PrEP trial comparing oral TDF alone to oral TDF/FTC and a gel containing TDF recommended discontinuing the use of oral TDF alone in a single arm of the study. That approach was deemed unable to show efficacy in the population of heterosexual women being studied. The other arms of the study continue to evaluate the other PrEP modalities. We do not yet know why this pattern emerged in these trials. Nevertheless, combined data show oral PrEP may be a vitally important prevention tool for some heterosexual populations.

Separate safety and effectiveness questions in data collected in heterosexual groups may unduly lengthen FDA review for MSM if the two approvals are bundled together. In addition to clarity surrounding the one trial that was stopped, FDA may have questions about:

  • Offering oral PrEP to women who use hormonal contraceptives concurrently;
  • Balancing risks to unborn children exposed to drugs in the absence of a known risk of exposure to HIV from an uninfected pregnant mother;
  • The basis of using two-drug combinations vs single drugs in heterosexual populations.

The US DHHS perinatal guidelines for HIV recently withheld recommendations for oral PrEP based on these concerns. If approval for both MSM and heterosexuals is bundled together, it may take many months to answer the questions affecting one group more than the other.

Harms result when the benefits of FDA approval are delayed for a safe and effective intervention:

  • Patients do not have the benefit of the safety and control measures that come with proper labeling, study- and FDA-regulated risk management;
  • FDA regulatory requirements are not able to be integrated with or to facilitate other efforts to demonstrate real world effectiveness in a cohesive organized manner;
  • FDA approval spurs insurance coverage from private and public sources needed to secure equitable access for disadvantaged populations;
  • The drug manufacturer will be restricted from communicating important data to clinics because of restraints on unauthorized marketing;
  • While PrEP should only be given to those who can truly benefit, a delayed approval means many of them will simply not get it at all. Whichever infections could have been averted will unfortunately occur.

These harms should not be imposed on either MSM or heterosexuals. FDA’s duty also requires the Agency to safeguard patients from uncertainty, and today, unfortunately, that uncertainty possibly weighs more heavily with one group more than the other. We must shore up that uncertainty promptly but not delay access to risk-reducing tools for MSM sooner if we can. Approval delayed, like justice, is approval denied.

FDA approval also influences the availability of PrEP in other countries hardest-hit by HIV/AIDS that look to the FDA for assurance that a new therapy is safe and effective. The largest international program for HIV treatment and prevention in developing countries, PEPFAR, considers FDA approval an important step in providing programming/access to PrEP.

Before the results of heterosexual PrEP studies were announced, the FDA and Gilead were reported to be ready to move forward on a review of PrEP for MSM. Now it looks like action on PrEP for MSM may take longer. Even six months of further delay could result in many preventable new HIV infections.

The FDA and Gilead should move quickly to ensure a thorough review of PrEP for MSM. It’s time. We also urge no delay to clear up data that will help heterosexual populations in need. Useful interventions often go through sequential approvals as was the case for Gardasil to prevent HPV related cancers and lesions in young women and men. Oral PrEP is not a magic pill but it adds to the available arsenal we have to prevent HIV.

Sincerely yours,

AIDS Action Committee of Massachusetts
AIDS Foundation of Chicago
AIDS Research Consortium of Atlanta
AIDS United
AVAC
Black AIDS Institute
Fenway Health
GMHC
Harlem United
International Rectal Microbicides Advocates
National Minority AIDS Council
Project Inform
San Francisco AIDS Foundation

A PDF version of this document is available here.

Press Release

AVAC says VOICE trial changes are disappointing, but do not close the door on PrEP for women; Continued PrEP research more important than ever

New York, NY — The announcement today that one arm of a large-scale HIV prevention trial known as VOICE will stop early is disappointing, but must be seen in context, according to the global advocacy organization AVAC. “Of course we are disappointed to hear that the tenofovir pill arm of VOICE will not be able to answer the question of whether or not the drug prevents HIV infection in women in this study,” said Mitchell Warren, AVAC Executive Director. “This development raises as many questions as answers about how oral pre-exposure prophylaxis, or PrEP, might work for women, making the continuation of the VOICE study, along with other research for new HIV prevention options for women, as essential as ever,” Warren added.

“As the field grapples with what the different PrEP results mean, researchers, public health experts and communities must share information, discuss implications and determine the best way forward for these important interventions,” Warren said.

After an interim review of trial data, the independent Data Safety and Monitoring Board (DSMB) for VOICE—a five-arm proof-of-concept trial that has enrolled more than 5,000 women in South Africa, Uganda and Zimbabwe—has recommended that the oral tenofovir arm of the study be stopped and that the women in that arm exit the trial in a structured process. The DSMB concluded that there was no possibility that daily use of the oral tenofovir pill (TDF, brand name Viread) would show effectiveness in preventing HIV in the context of the VOICE trial. The trial will continue to evaluate two other antiretroviral-based products—oral TDF/FTC (a combination of tenofovir and emtricitabine (FTC), brand-name Truvada) and 1% tenofovir gel. Importantly, the DSMB found no safety issues in any arm of the trial.

The data that form the basis for the DSMB’s recommendation were not released at the time of this announcement and will not be made available to the VOICE research team and public until data from all arms of the trial are analyzed when the trial is complete.

“VOICE remains a pivotal study. We commend the VOICE trial team, the members of the DSMB and especially the more than 5,000 women who are participating in the trial. Despite the fact that oral tenofovir did not work in VOICE, two active arms of the trial are continuing and, importantly, no safety issues have been found,” said Warren. “While we don’t yet know why oral tenofovir did not work in this trial, VOICE will still provide critical information about both oral and topical PrEP that will help move the HIV prevention research agenda forward,” Warren said.

VOICE launched in 2009 with a five-arm trial design to evaluate the safety and effectiveness of oral tenofovir, oral TDF/FTC and 1% tenofovir gel, each used daily, compared to a placebo gel or placebo pill. The DSMB recommendation affects only the women in the oral tenofovir arm. While these women will exit the trial, participants in the other four arms will remain in the study.

In the last 18 months, there have been results from several trials of ARV-based prevention in HIV-negative people. So far, data from four effectiveness trials of various PrEP strategies in women have been reported. The data are mixed and require further investigation. See table of PrEP and microbicide trials below as well as at avac.org/trials/prep.

“Taken together, the data leave a range of questions on how oral and topical PrEP might be used as a prevention strategy for women. One of the most important questions to answer with urgency is which strategies will work for women throughout their lives, and VOICE will continue to be a key trial for answering this question,” Warren said. “The different PrEP results we’ve seen in the past year underscore the need for close coordination of clinical trials testing the same or similar strategies and of planning for implementation,” Warren said, noting that plans were still underway to launch demonstration projects of oral TDF/FTC for HIV prevention among gay and bisexual men and transgender women, on the basis of the data from the iPrEx trial.

Additional information from VOICE, FEM-PrEP, Partners PrEP, iPrEx OLE, the FACTS 001 topical microbicide trial and planned PrEP demonstration projects will help guide decisions about the best use of oral and topical PrEP among different populations and will answer important questions about the potential for real-world use of PrEP among different populations and in different contexts.

“Medical research is often complicated, and we must expect setbacks along the way. But with 2.6 million new HIV infections every year, it is imperative that we continue to look for new ways to curb the epidemic,” Warren added. “There will never be a silver bullet for HIV prevention, so we must continue to rapidly expand testing, treatment and medical male circumcision, amongst the array of evidence-based interventions, while also accelerating the research and development of additional new options, notably oral PrEP, topical microbicides and vaccines to protect against HIV.”

More information about ongoing PrEP research is available at avac.org/prep. More information about DSMBs is available at avac.org/dsmb.

A PDF version of this press release is available here.

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

 

Contact: 


Mitchell Warren, [email protected], +1-914-661-1536


Kay Marshall, [email protected], +1-347-249-6375

Press Release

Open letter from HIV-positive prevention advocates rejects misinformation about pre-exposure prophylaxis (PrEP)

Close to 100 openly HIV-positive gay and bisexual men from across the United States and around the world have signed a new letter (http://tinyurl.com/pozPrEPletter) calling for an open discussion, “based on facts rather than on fear or misinformation,” of the challenges and opportunities presented by pre-exposure prophylaxis (PrEP) for HIV prevention in gay and bisexual men and transgender women. The new open letter is designed in part to urge FDA review of PrEP and to clarify facts about important PrEP research that advocates say have been misrepresented in a paid ad campaign sponsored by the AIDS Healthcare Foundation (AHF).

Pre-exposure prophylaxis, or PrEP, is a new HIV prevention method in which an uninfected person takes a daily HIV medication to reduce HIV infection risk. Data from an international study released in November, 2010 called iPrEx found that men and transgender women who have sex with men who received a daily single-tablet dose of the HIV drugs tenofovir and emtricitabine along with condoms and safe sex counseling had an average of 42% fewer HIV infections than those who received condoms and counseling alone. Much higher rates of protection were achieved among participants who took PrEP consistently.

Most of the HIV prevention community welcomed the news of a new tool that could significantly reduce infections in the populations at highest risk for HIV in many parts of the world. One HIV treatment provider, however, the AIDS Healthcare Foundation, has taken out an extensive series of full-page advertisements in gay papers around the country claiming that gay and bisexual men will act recklessly and will spread HIV if they are allowed to use PrEP. The AHF ad campaign claims that it is supporting gay and bisexual health by urging the U.S. FDA to ignore the PrEP study.

Today’s open letter challenges both the tone and content of the AHF communications and encourages “a full and factual discussion of the pros and cons of PrEP… based on facts, not misinformation.” Reminding the world that “gay and bisexual men invented safer sex…and have worked tirelessly to prevent new HIV infections,” the letter also points out that gay and bisexual men account for more than half of new HIV infections in the United States and are in particular need of new HIV prevention approaches.

“As an HIV positive gay man I signed this letter because I learned from experience we need all credible options to stop this epidemic. I owe my life to the fact that advocates and activists have pushed hard for decades to make effective AIDS drugs available to HIV-positive people,” said Kali Lindsey. “Now we know that AIDS drugs can also play an important role in the health and well-being of HIV-negative gay men, how could we not move forward to reap the benefits of this research. It is not an option to ignore these findings.”

In July of this year the results of two addition studies, Partners PrEP (led by the University of Washington Department of Global Health) and TDF2 (led by the U.S. Centers for Disease Control and Prevention) demonstrated that PrEP is also safe and effective in heterosexual women and men. The Partners study found that participants who received PrEP experienced an average of 62-73% fewer HIV infections than those who received placebo. The TDF2 trial, conducted by the U.S. Centers for Disease Control found that the risk of HIV infection dropped by an average of 63% among those who received PrEP in addition to condoms and counseling. Data expected from the FEM-PrEP trial, which was stopped in April after it was determined that the trial would not be able to provide an efficacy result, will also provide additional information about PrEP use among women.

The new letter acknowledges that the PrEP, “is no magic solution to the HIV crisis,” and that research, “raises important questions…includ(ing) how to best support regular PrEP use; how to ensure the continued use of condoms and other precautions for those who decide to take PrEP; how to target PrEP to those who will benefit most; and how to pay for this new HIV prevention tool.” Its signers express their commitment “to promoting safer sex and the open exchange of accurate information on HIV prevention,” and to “clarify the facts about PrEP, open up community discussion and make clear our belief that we are entitled to respect, accurate information and new HIV prevention tools.” The letter concludes by calling on all interested parties to “get the facts about PrEP, seek information, and express opinions…but to do so based on real information, not fear of the scientific process or prejudice against gay/bi men.”

The letter was coordinated by a group of U.S.-based AIDS advocacy organizations, including AIDS Foundation of Chicago, AVAC, International Rectal Microbicide Advocates (IRMA), and Project Inform.

A copy of the sign-on letter supporting an informed debate on PrEP for gay and bisexual men is below. Openly HIV-positive gay and bisexual men who wish to add their name to the letter can do so at: http://tinyurl.com/pozPrEPletter.

Contact:
Kay Marshall (AVAC), [email protected], +1-347-249-6375

Press Release

Government Incentives Should Extend to AIDS Vaccine Development

NEW YORK — The AIDS Vaccine Advocacy Coalition (AVAC) today hailed new federal legislation that provides financial incentives for private industry to develop vaccines and other antidotes to protect people in the event of biological or chemical weapon attacks.

But AVAC called on Congress and the administration to extend the same kind of incentives as those provided under Project Bioshield to spur private investment in a vaccine to combat AIDS.

“Every day, 8,000 people die of AIDS-related illness and 14,000 become newly infected with HIV,” said Mitchell Warren, AVAC executive director. “By tearing apart the fabric of entire societies in the developing world and destabilizing governments, AIDS is as much of a national security threat as various agents of biological and chemical warfare.”

Of the estimated $540-$570 million spent for global AIDS vaccine research in 2002, less than 25 percent came from private industry, Warren said. Most of the work was financed by governments and other public-sector sources.

“If we are to find an AIDS vaccine, we must establish new incentives for private industry to greatly accelerate its involvement,” Warren said.

Project Bioshield, signed into law by President Bush on Wednesday, will give private companies $5.6 billion in incentives over the next 10 years to develop and stockpile vaccines and other antidotes to chemical and germ warfare. Among the carrots are guaranteed government purchase of the products and accelerated regulatory approval.

“These are exactly the kind of incentives we need to get the private sector, with its wealth of expertise, more involved in developing a vaccine against the worst plague of modern times,” Warren said. He said similar efforts should be undertaken to spur private investment in vaccines to combat two other killers in the developing world – TB and malaria.

AVAC is a non-profit and non-partisan group that works to speed the ethical development of an AIDS vaccine. It is funded by the Bill & Melinda Gates Foundation, the Ford Foundation and other philanthropic groups.

Press Release

Report on HIV Prevention Research Funding Says New Investment Critical to Capitalize on HIV Prevention Research Breakthroughs

Rome – In the last year, promising trial results and critical scientific breakthroughs have changed the HIV prevention landscape, providing new opportunities for both a broader response to the epidemic with new prevention options and broader clinical and laboratory agendas with new research targets. At the same time, investment in biomedical HIV prevention research remained stable despite the effects of the recent global economic downturn, according to a new report released today in Rome at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention. 

Capitalizing on Scientific Progress: Investment in HIV Prevention R&D in 2010 is the seventh annual report from the HIV Vaccines and Microbicides Resource Tracking Working Group documenting investments in biomedical HIV prevention research from public, philanthropic and commercial sectors. This year’s report argues that capitalizing on recent promising scientific breakthroughs will require substantial additional and sustained investment from a broader set of donors.

The major, and surprising finding of the report, given the global funding environment, is that overall investment in HIV prevention R&D had actually increased, with the modest exception of a one percent decline in vaccine R&D. The report documented a total US$1.19 billion investment in research and development (R&D) for four key HIV prevention options: preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) using antiretroviral drugs, and operations research related to medical male circumcision. Even in the aftermath of a global recession, this investment approached the previous historical high of US$1.23 billion reached in 2007 for these four prevention technologies.

Yet to capitalize on the recent exciting prevention breakthroughs being discussed at the IAS conference, more investment will be needed across prevention technologies and from bench research to operational and implementation research.

“Certainly in this era of economic restraint it is good news that donors continue to see the value of investing in prevention research,” said Paul DeLay, Deputy Executive Director, Programme, UNAIDS, the Joint United Nations Programme on HIV/AIDS. “But as we capitalize on the recent breakthroughs and move quickly to make new forms of prevention available to those who need them most, we need donors to also move quickly to ensure that funding shortfalls do not become roadblocks.”

There is an urgent need to direct resources to accelerate promise into progress. Yet the report recognized that funders continue to confront budgetary constraints, with some having reduced or eliminated their HIV prevention research programs altogether. Funding for HIV prevention research also remains highly concentrated among relatively few funders, and the Working Group warns that this narrow base of funding will threaten the sustainable research effort required at this critical time and highlights the need for broadening that base, importantly including emerging economies.

“The recent promising results of PrEP and treatment as prevention trials tell us that thirty years into the epidemic we may finally be on the path to ending AIDS,” said Mitchell Warren, AVAC executive director. “New prevention options—medical male circumcision, PrEP, microbicides and eventually vaccines—will play a critical role in reducing the cycle of new infections. As we look toward the next 30 years of AIDS, investment in prevention research has never been more important. Going forward we need funding structures that are flexible, agile, and generous enough to adapt rapidly to new opportunities.”

“We have seen tremendous progress in HIV prevention research over the last two years,” said Margaret McGlynn, President and CEO of the International AIDS Vaccine Initiative (IAVI). “Sustaining the momentum built through these advances depends on access to stable funding that can be flexibly applied to the most promising areas of research. This will allow us to build upon the field’s successes and to move promising concepts from the pipeline into clinical trials as swiftly as possible.”

“The recent exciting results in the PrEP and microbicide fields are proof that investment in HIV prevention research is bringing women and men around the world much closer to having a broad range of effective HIV prevention options,” said Zeda Rosenberg, CEO of the International Partnership for Microbicides (IPM). “Wise investments now in laboratory and clinical research, and in efforts to roll out new interventions will pay off as HIV infections decline significantly in the coming decades.”

The report is available online at: www.hivresourcetracking.org. 

Kay Marshall (AVAC), [email protected], +1-347-249-6375
Sophie Barton-Knott (UNAIDS), [email protected], +41 79 514 6896/
+41 22 791 1697
Lauren Wesolowski (IAVI), [email protected], +1-212-328-7420

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The Working Group is composed of AVAC, the International AIDS Vaccine Initiative (IAVI), the International Partnership for Microbicides (IPM), and the Joint United Nations Programme on HIV/AIDS (UNAIDS).

Press Release

AVAC says results of new PrEP trials provide clear evidence that antiretroviral drugs for prevention can help end the AIDS epidemic; calls for quick action on results

New York, NY – Results from two African studies of pre-exposure prophylaxis, or PrEP, released today provide clear evidence that the antiretroviral drugs used to treat HIV can also be used to prevent HIV among heterosexual men and women at risk of HIV infection.

“These results are tremendously exciting and confirm that we are at pivotal period in the AIDS epidemic,” said Mitchell Warren, AVAC executive director. “Antiretroviral (ARV) drugs for HIV treatment began to turn the tide of the epidemic 15 years ago, and it is clear that also using ARVs for HIV prevention will strengthen our response to AIDS. PrEP, ARV-based microbicides and treatment as prevention are powerful tools to help end the cycle of new infections and end the epidemic.”

“We now have data that earlier treatment initiation in HIV-positive people can reduce risk of HIV transmission—and that use of ARVs in HIV-negative people can reduce risk of infection. There is a global imperative to act on these results without delay,” Warred added. “Now is the time to include ARV-based prevention in national plans, applications to the Global Fund to Fight AIDS, Tuberculosis and Malaria and donor priorities. We need ambitious pilot and demonstration projects to guide programmatic design, along with national and international guidance on how best to use ARVs as lifesaving prevention tools. The next steps will not be simple but they will be essential. Scientific data do not change the world—programs and policies backed by civil society, donors, implementers and governments do. The countries where PrEP trials took place should lead the way in these critical efforts.”

“We congratulate the trial sponsors, scientific collaborators and partners who conducted these trials. We especially want to thank the more than 10,000 men and women whose altruism and commitment as trial volunteers made this effort possible,” Warren said. “These volunteers and their communities have made an inestimable contribution to HIV prevention research and to the eventual development of new ways for men and women to protect themselves from HIV.”

The Partners PrEP study in Kenya and Uganda enrolled 4,758 heterosexual couples in which one partner was HIV-positive and the other HIV-negative. The trial showed that both tenofovir (TDF, marketed as Viread) and tenofovir plus emtricitabine (TDF/FTC, marketed as Truvada) taken daily can reduce the risk of HIV transmission among both men and women. In the trial, daily oral TDF reduced HIV risk by an estimated 62 percent infections (95% CI 34 to 78, p=0.0003) and daily oral TDF/FTC reduced HIV risk by an estimated 73 percent (95% CI 49 to 85, p<0.0001) when compared to a placebo. Both drugs were effective in both men and women, and there were no significant safety events in the trial.

Separately, the TDF2 study in Botswana enrolled just over 1,200 sexually active men and women. At the time of its completion, TDF2 was an expanded safety trial that was not designed to provide information on effectiveness. However, analysis of final data on numbers of infections in the active and placebo arms indicated that daily oral TDF/FTC reduced the risk of HIV infection in both men and women participants by an estimated 62.6 percent (95% CI 21.5 to 83.4, p=0.0133) compared to those who received the placebo.

AVAC looks forward to continued discussion of the meaning of these findings for men and women in different contexts. Additional data from these studies not released today, but expected over the coming months, will help guide these discussions. These include data on drug resistance from Partners PrEP, data on drug levels in blood plasma, cells and tissue samples, viral genotyping of infecting strains within Partners PrEP couples to identify linked and unlinked transmissions, and other information.

These results add to a growing body of evidence confirming the powerful potential of antiretroviral drugs for HIV prevention. This includes the positive results of the iPrEx trial, a study of daily oral TDF/FTC in gay men, other men who have sex with men, and transgender women, which showed a 44 percent reduction in HIV risk compared to placebo; CAPRISA 004, a trial of 1% tenofovir gel in heterosexual women, which showed that women who received the gel had an estimated 39 percent lower risk of infection compared to those who received an inactive placebo gel; and HPTN 052, which demonstrated a 96 percent reduction in HIV transmission among HIV serodiscordant couples when the HIV-positive partner received early antiretroviral treatment.

“At this critical juncture in biomedical prevention research, it is essential that governments, program implementers and donors move with speed to identify and enact the next steps suggested by the findings from these two trials of pre-exposure prophylaxis and from other recent successful trials,” Warren said.

Today’s findings make even more critical that stakeholders act on recommendations put forward in a statement, “We CAN End the AIDS Epidemic,” which has been endorsed by more than 30 organizations and close to 400 individuals around the world to date. Next steps should include:

  • Trial teams and Gilead, which donated the study drug, should ensure continued access to study drug for all participants in the Partners and TDF2 studies, including those in the placebo arms.
  • National governments should work with donors and program implementers to identify the implementation research needed to address unanswered questions and evaluate the potential impact of PrEP in key populations and contexts and to evaluate treatment as prevention, building on the result from HPTN 052.
  • At national and international levels, new findings from Partners and TDF2 as well as data from iPrEx and HPTN 052, should be integrated into ongoing strategic planning, funding proposals for the Global Fund to fight AIDS, Tuberculosis and Malaria and other processes.
  • National AIDS programs along with civil society and other key partners must swiftly develop clear messages for a range of audiences, including at-risk individuals and communities, program implementers, policy makers, regulators and others, about what these data mean—and what questions remain to be answered.
  • Funders, trial sponsors and researchers should prioritize additional research for PrEP and microbicides using different agents and mechanisms of delivery.

“Because the drugs evaluated in the Partners and TDF2 PrEP trials are licensed and available as treatment for HIV-positive people, men and women at risk of HIV infection need immediate information about what these data tell us and what questions remain. The US Centers for Disease Control and Prevention (CDC) moved quickly to provide interim guidance for PrEP use among men who have sex with men in the United States following the data from the iPrEx trial. Now CDC should move quickly to issue updated guidance for all populations in which PrEP has been shown to be effective.

At the same time, the World Health Organization (WHO) must move quickly to develop guidance for all populations for whom PrEP has now been shown to be effective,” Warren said. “And African countries, especially those where these trials took place, must also move quickly to determine the place of both PrEP using TDF/FTC or TDF, as well as earlier initiation of ARVs, in national prevention programs.”

In addition, the VOICE trial, which is looking at the use of oral PrEP and vaginal microbicides among women in several African countries, is expected to provide additional data that may help guide both PrEP and microbicide programs. “We know that the VOICE team and its independent Data and Safety Monitoring Board will be carefully reviewing the data from both of these trials and evaluating the potential impact on VOICE, and that the trial will provide critical additional information about both PrEP and tenofovir gel microbicides.” Warren said. Results from the VOICE trial are expected in 2012. Forthcoming data from the FEM-PrEP trial, which was stopped earlier this year after it was determined that the trial would not be able to provide an efficacy result, will also provide additional information about PrEP use among women.

More information is needed about issues such as adherence and possible drug resistance as well as optimal program design, integration of PrEP and earlier ART initiation into comprehensive prevention programs, and cost. Gilead announced earlier this month that it would make both drugs studied in these trials available to the UNITAID patent pool, which seeks to make generic versions of ARVs more affordable in developing countries, and which may help make PrEP more affordable.

Adherence—the ability to take PrEP as prescribed by the trial protocol—is a critical component of efficacy. Initial findings from the Partners PrEP study showed high reported adherence for the once-daily regimen. It will be important to learn why and how adherence was high in this study and what lessons can be learned for eventual rollout of PrEP. At the same time, research into intermittent dosing (e.g., weekly, semi-weekly or around the time of sex), which may be easier from some people to adhere to, is needed. Moreover, additional research is still urgently needed for other methods where adherence is less important, such as vaginal rings with monthly release, periodic injectable forms of ARVs and vaccines.

As with other HIV prevention trials, Partners and TDF2 provided a comprehensive HIV prevention package. All trial participants received condoms, safer sex counseling and treatment of sexually transmitted infections. Female participants were also provided with effective contraception. Participants were frequently tested for HIV and were intensely counseled on the importance of adhering to the daily regimen and using condoms and other prevention options—a level of counseling and testing not easily achieved outside of a clinical trial.

Demonstration projects and additional research can provide important information about how PrEP programs should be structured to account for these “real world” issues. Such projects should be prioritized and fully funded to provide answers as quickly as possible.

“As we move towards PrEP implementation, it is critical to remember that millions of HIV-positive people around the world lack access to the HIV treatment they need, which is often the same drug used in these trials,” Warren said. “We can and must find a way to ensure that PrEP is a part of comprehensive, well-funded response to HIV. That means ensuring access for all who need it to existing HIV prevention and treatment options, including universal access to treatment and care, PrEP, treatment as prevention and medical male circumcision; ensuring continued research to find and refine effective new options, including microbicides, vaccines, new and improved treatment options and a cure; and planning for integrating these new interventions into fully funded combination programs.”

More information on these and other PrEP trials can be found online at www.avac.org/prep. The sign on statement is available at endtheepidemic.org.

A PDF version of this press release is available here.

 

Contact:
Mitchell Warren, [email protected], +1-914-661-1536
Kay Marshall, [email protected], +1-347-249-6375

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

Press Release

Activists and Researchers: Evidence Shows We Can End the AIDS Epidemic; International coalition calls for clear actions from world leaders

New York, NY – An international coalition of scientists and activists today launched a common platform for ending the AIDS epidemic. Thirty years into the epidemic, as world leaders come together at the United Nations to recommit to a global AIDS response, the broad-based international coalition issued a statement calling for world leaders to support a rational, evidence-based approach to responding to AIDS. The group also calls for additional signatories to the declaration.

“As at so many other critical points in the epidemic, we have the opportunity now to use the fruits of science and research to show the way forward. Putting more people on AIDS treatment will save lives and prevent new infections, and will also help build and strengthen platforms for delivering comprehensive health services in resource-poor settings,” said Paul Farmer, Harvard University Professor and co-founder of Partners In Health. “We have the knowledge and the tools to reverse the epidemic—and we must not fail to use them.”

The declaration, “We Can End the AIDS Epidemic,” argues that highly-active antiretroviral treatment (ART) for HIV positive people is a preventive strategy that is a cornerstone to ending the epidemic.

The founding group of signatories includes African Services Committee, AIDS Foundation of Chicago, AIDS United, amfAR, AVAC, ATHENA Network, Black AIDS Institute, Canadian HIV/AIDS Legal Network, Fenway Health/The Fenway Institute, GIV, Health GAP, HIV Prevention Justice Alliance, International Community of Women Living with HIV, International Rectal Microbicide Advocates, International Treatment Preparedness Coalition, New HIV Vaccine and Microbicide Advocacy Society, Open Society Public Health Program, Partners In Health, Project Inform, Treatment Action Campaign, Treatment Action Group, and the Wits Institute for Reproductive Health and HIV, and more than two dozen leading the global AIDS researchers and advocates.

“This statement represents the common vision of scientists and activists to halt the epidemic. For the first time in three decades, we now have the real potential to end the AIDS epidemic. The question now is will we?” said Mitchell Warren, AVAC executive director. “Recent breakthroughs in AIDS vaccine, PrEP and microbicide research suggest powerful, additional tools for the future. Right now, the scientific evidence that treatment is prevention must serve as a clarion call to funders, policy makers and program implementers to move forward boldly and quickly to capitalize on the conclusive evidence provided by the clinical trial HPTN 052.”

HPTN 052 found that earlier initiation of antiretroviral treatment provides a health benefit to HIV-positive people, and is a highly powerful tool for preventing transmission to sexual partners.

The statement calls for:

  • World leaders to adopt ambitious treatment and prevention targets.
  • Donors, including PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria, to evaluate existing and new funds with core activities including antiretroviral treatment for individuals with CD4 cell counts at 350 or above
  • All working on the AIDS response to end non-integrated, artificially-separated approaches to funding and delivering treatment and prevention services.
  • Donors, communities, implementers, industry and researchers to map and execute an implementation research agenda for ART as part of combination prevention strategies.

“The most expensive, least effective strategy is to continue spending on AIDS the way that we are today,” said Nono Eland of South Africa’s Treatment Action Campaign. “We need more resources and better strategy. Funds need to be aligned with what is known to work—and reprogrammed where needed. We have no time to waste. World leaders at the UN this week should make clear commitments to the platform outlined in this statement.”

According to the declaration, and consistent with a new investment framework from UNAIDS published last week in the Lancet, funding needs to be directed to evidence-based strategies with combination ART as a cornerstone of a set of proven strategies to prevent and treat HIV, including male and female condoms, male circumcision, prevention of vertical transmission, behavior change programs that target social norms as well as individual risk, and activities addressing key populations including sex workers, men who have sex with men and harm reduction programs for injecting drug users. Funds that are not aligned with these core activities need to be justified and, where applicable, reprogrammed.

“The scientific evidence is clear. We know that early treatment has health benefits for HIV-positive people, and we now know that treatment also provides clear benefit for prevention,” said Kenneth H. Mayer, M.D. of Fenway Health. “As we work to scale up HIV treatment programs, we must also scale up and sustain research that builds on important proof of concept for biomedical prevention options, including pre-exposure prophylaxis, or PrEP, microbicides and vaccines to prevent HIV. Widespread treatment access coupled with new prevention options will be essential as we move to end this epidemic.”

The declaration grew out of a think tank on optimizing the potential of ARV-based prevention convened by AVAC with support from the John M. Lloyd Foundation. The meeting brought together 25 HIV experts to discuss the way forward capitalizing on mounting evidence of the broad benefit of widespread access to antiretroviral treatment.

The full text of the declaration, along with a list of signers, is available at www.avac.org/endtheepidemic, where additional individuals and organizations can also sign on.

Contact:
Mitchell Warren, [email protected], +1-914-661-1536
Kay Marshall, [email protected], +1-347-249-6375

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

Press Release

HPTN 052 trial confirms ARV treatment is a powerful prevention tool: “Early initiation of treatment will be fundamental to turning the tide of the epidemic,” AVAC says

New York, May 12, 2011 – Today the sponsors of a randomized clinical trial known as HPTN 052, which is evaluating combination antiretroviral therapy for HIV prevention, announced that randomization would halt due to overwhelming evidence of benefit.

“We now have evidence from a randomized trial confirming what has been seen in observational settings: ARV treatment is prevention,” said AVAC Executive Director Mitchell Warren. “These data must serve as a clarion call to funders, policy makers, civil society and implementers. HPTN 052 shows a prevention benefit that must be translated into programmatic reality. If deployed effectively, efficiently and ethically, early initiation of treatment will be fundamental to turning the tide of the epidemic.”

HPTN 052 is a large, multi-site, randomized trial designed to determine whether antiretrovirals, medicines currently licensed to treat HIV infection, can prevent the sexual transmission of HIV among couples in which one partner is HIV-infected and the other is not (serodiscordant couples). Nearly 1,800 of these HIV-serodiscordant couples from four continents are participating in the trial. At the time of enrollment, the HIV-positive partners had CD4 cell counts between 350 and 550 cells/cubic millimeter and so were not eligible for ARVs based on most national guidelines. Couples who enrolled were randomly assigned to one of two groups. In one group, HIV-positive partners received antiretroviral therapy immediately. In the other group, HIV-positive partners deferred initiation of ARV treatment until they had the clinical or laboratory findings indicating ARV eligibility based on national guidelines.

In a scheduled review of interim data, the trial’s independent Data Safety and Monitoring Board (DSMB) found clear evidence that providing immediate antiretroviral therapy to the HIV-positive partner significantly reduced the risk of transmitting HIV to their HIV-negative partner. The trial team has used viral genetic analysis to establish which new infections were linked to the HIV-positive partner. They reported that there was one such linked HIV infection in the immediate treatment group versus 27 infections in the group that began treatment according to national guidelines.

Based on this indication of a clear benefit, the DSMB recommended that the trial halt randomization. The trial team announced today that it would do so, and begin offering immediate treatment to all HIV-positive partners. All couples will continue to be followed until the protocol-defined end of the trial.

“We congratulate the trial sponsors, scientific collaborators and partners who conducted this landmark global trial. We especially want to thank the nearly 1,800 HIV-serodiscordant couples from four continents whose commitment as trial volunteers made this effort possible,” Warren said. “As the global community reflects on the prevention and treatment implications of this trial, we must also consider current and future trials working with serodiscordant couples, and civil society voices must contribute to the way forward.”

“Today’s result should be viewed in light of other recent findings from trials using ARVs for prevention,” said Warren. “The recent results from the iPrEx trial showed that PrEP is effective in gay men and transgender women, while the CAPRISA 004 microbicide trial showed that 1% tenofovir gel is effective at reducing HIV risk for women.”

“Together, these results allow us to imagine a world in which men and women seek HIV testing with the knowledge and confidence that they will receive a range of highly effective options for staying healthy and protecting themselves and their partners—whatever the test result,“ Warren added. “The results of the study require us to rethink how we structure the delivery and funding of HIV services overall.”

“The financial, human and technical resources needed to translate the HPTN 052 trial finding into a public health breakthrough on a national or global level will not come overnight. And ARVs alone will not solve the epidemic,” said Warren. “Existing prevention tools including male and female condoms, syringe exchange, male circumcision, behavior change programming, prevention of vertical transmission, and HIV testing, remain critical as do structural interventions, stigma reduction initiatives and comprehensive care and treatment programs. We also still need to maintain and build on the momentum of other recent positive results from vaccine, microbicide and PrEP research.”

“Realizing this vision will require substantial resources,” said Warren. “The upcoming UN High Level Meeting on AIDS should set treatment and prevention targets that take the HPTN 052 results into account,” Warren said. “We need to start critical discussions and come to quick decisions about where and how to deploy treatment as prevention in the short-term. Government and international normative agencies now have a critical mass of data to publish guidelines for appropriate implementation of treatment as prevention in concert with other prevention methods.”

“Now is the best time to invest in an expanded response to the AIDS epidemic. AVAC stands with the global community of advocates for HIV prevention, treatment, research and implementation to expect and demand an extraordinary response to this unprecedented epidemic,” Warren added.

Contact:
Mitchell Warren, +1 914-661-1536, [email protected]

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

Press Release

Discontinuation of the FEM-PrEP Trial Disappointing, AVAC Says; Calls for continued research to find new ways to end the HIV epidemic

New York, 18 April 2011 – At a scheduled, interim data review, the Independent Data Monitoring Committee (IDMC) for the FEM-PrEP study of oral pre-exposure prophylaxis (PrEP) using daily TDF/FTC (brand-name Truvada) determined that the trial would not be able to answer the question of whether the study drug decreased risk of HIV infection among HIV-negative women at risk via sexual transmission. The IDMC has, therefore, recommended that the study be discontinued.

“Today’s announcement about the FEM-PrEP study is disappointing,” said Mitchell Warren, AVAC executive director. “However, it must be seen as what it is – the closure of a single trial in a field that has generated exciting results in the recent past. Even with this finding, there is still a strong rationale for continuing other trials, including those in women, in hopes of obtaining better results in the future.”

The FEM-PrEP trial tested the same drug and daily dosage of TDF/FTC (also known as Truvada) as the landmark iPrEx PrEP trial among gay and bisexual men and transgender women. Last November, results of the iPrEx trial showed a 44 percent reduction in HIV risk overall in participants who received TDF/FTC compared to those who received the placebo. In July 2010, results of the CAPRISA 004 study showed a 39 percent reduction in HIV risk among women who used a 1% tenofovir gel microbicide compared to those who received a placebo gel. In both trials, there was evidence that adherence matters – that participants who used the intervention most consistently had the highest levels of protection.

Two other ongoing trials in sub-Saharan Africa are evaluating oral TDF/FTC and/or TDF alone among heterosexuals. The VOICE trial is evaluating oral TDF and TDF/FTC as well as 1% tenofovir gel in 5,000 women in sub-Saharan Africa. Partners PrEP is evaluating oral TDF and TDF/FTC in the HIV-negative member of couples in which one partner is HIV-infected.

“The premature closing from FEM-PrEP does not predict the findings from either VOICE or Partners PrEP,” Warren said. “It is too soon to tell whether the differences observed between iPrEx and FEM-PrEP are due to the route of exposure, pill-taking behavior, biological differences in drug activity, or some other factor. Along with further analysis of FEM-PrEP data, VOICE, Partners PrEP and other ongoing trials will add critical pieces to the puzzle of if and how to deploy PrEP as an effective prevention tool.”

“We commend the FEM-PrEP trial team, the members of the IDMC and especially the nearly 2,000 women who participated in the trial. Despite the inability of the trial to answer the question of whether TDF/FTC reduces women’s risk of HIV infection, FEM-PrEP has provided and will continue to provide key information that will help move the PrEP research agenda forward,” Warren said.

Further analysis of the FEM-PrEP data will provide a better of understanding of the observation that there was a higher pregnancy rate among women in the active drug arm of the trial, compared to those in placebo arm.

In addition to VOICE and Partners PrEP, there is an ongoing PrEP efficacy trial among injection drug users and a soon-to-be-launched follow-on to iPrEx known as the iPrEx Open Label Extension study, or iPrEx OLE. There are still close to 20,000 participants involved in PrEP trials around the world.

“Medical research is often complicated, and we must expect setbacks along the way. But with 2.6 million new HIV infections every year, it is imperative that we continue to look for new ways to curb the epidemic,” Warren added. “The success of the iPrEx and the CAPRISA 004 trials have shown the promise of ARV- based prevention options as part of a comprehensive prevention package that includes condoms behavioral counseling and treatment of other sexually transmitted diseases. There will never be a silver bullet for HIV prevention, so we must continue to seek a variety of new options to protect those at risk through different routes of transmission and throughout their lives.”

More information about ongoing PrEP research is available at avac.org/prep.

 

Contact:
Mitchell Warren, [email protected], +1-914-661-1536
Kay Marshall, [email protected], +1-347-249-6375

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About AVAC: Founded in 1995, AVAC is an international non-profit organization that uses education, policy analysis, advocacy, and community mobilization to accelerate the ethical development and eventual global delivery of AIDS vaccines and other new HIV prevention options as part of a comprehensive response to the pandemic.