New York, NY – Results from the Bangkok Tenofovir Study published online today in The Lancet provide additional evidence that daily oral tenofovir-based pre-exposure prophylaxis (PrEP) reduces HIV infection risk when taken consistently. The results from the study—the first conducted among people who inject drugs—are consistent with previous studies among men and women primarily at risk of acquiring HIV through sex. They provide additional support for moving forward to ensure that people who can benefit from PrEP have access to it.

“These results underscore what we’ve learned in a range of studies—daily tenofovir-based PrEP works when you take it,” said Mitchell Warren, AVAC executive director. “Although there is more to learn about how this or other PrEP strategies work in men and women who inject drugs, this study offers the first indication that oral PrEP may reduce the risk of HIV infection via needle exposure. Comprehensive harm reduction, along with human rights protections, are the fundamental HIV prevention tools for injecting drug users. We need to continue to roll out proven prevention and find out more about how this oral PrEP strategy might work in a group that is at very high risk for HIV infection and has too often been ignored.”

“We now need to get serious about making PrEP available to those who can benefit. More than two and a half years after the first positive results from a PrEP trial, little has been done to answer critical questions about the best ways to roll out daily oral PrEP to key populations worldwide. Within the next year, a comprehensive package of demonstration projects should be planned, funded and launched in countries around the world,” Warren said.

Data from previous oral PrEP studies showed varying levels of effectiveness of tenofovir-based prevention for heterosexual men and women, and for men and transgender women who have sex with men. In July 2012, the US Food and Drug Administration (FDA) approved daily oral TDF/FTC (marketed as Truvada) for HIV prevention for all adults at risk of HIV from sexual transmission based on data from several PrEP trials that evaluated TDF/FTC for PrEP. Only one other PrEP study—Partners PrEP, which enrolled serodiscordant couples—evaluated daily oral tenofovir disoproxyl fumarate (TDF, marketed as Viread), as well TDF/FTC. It will be critical to examine the cost and feasibility of both daily TDF and TDF/FTC in light of these new data.

The Bangkok Tenofovir Study, which was conducted by the US Centers for Disease Control and Prevention (CDC), the Bangkok Metropolitan Administration and the Thailand Ministry of Public Health, found that a daily dose of the drug tenofovir reduced the risk of HIV infection by 49 percent overall and at a higher rate (up to 74 percent) among trial participants who had detectable tenofovir in their blood, an indication that they were taking the drug consistently. The study, which began in 2005, enrolled more than 2,400 men and women who were part of a drug treatment program run by the city of Bangkok.

The trial team states the conclusion that the HIV infections that occurred were primarily the result of injection drug use, rather than sexual exposure. The team also reports consistent decreases in reported risk behaviors including injection drug use, needle sharing and unprotected sex in both study arms; also of note, the preventive benefit was only observed after the first three years of follow-up.

“People who use drugs also have sex, and there is no way of distinguishing between infection acquired via sex versus drug use. This is one reason why this PrEP strategy cannot be viewed as a replacement for proven prevention such as syringe exchange and drug substitution programs that specifically reduce risk of HIV via drug use. All countries need to offer these services without criminalizing, stigmatizing or infringing on the rights of those who need them,” Warren said. “However, this is the first trial to provide evidence for a prevention option that could protect against HIV infection through both sexual contact and injecting drug use—and this is an exciting finding that must be followed up. PrEP could be a powerful additional tool for some people who inject drugs,” Warren added.

CDC’s new interim guidelines also released Wednesday include important guidance for how PrEP can best be used to help people who inject drugs protect themselves. Consolidated US Public Health Service Guidelines on PrEP use for all risk groups, which will include more detailed guidance on PrEP use for injecting drug users, are expected to be released later this year.

“We commend the CDC for acting quickly to put these interim guidelines in place to help individuals and their health care providers make informed decisions about PrEP use in the context of comprehensive HIV prevention. PrEP is not a silver bullet or a simple solution, but it is an option that can be life-saving for some individuals,” Warren added.

“PrEP using tenofovir-based drugs is a niche product that cannot and will not replace other options that are part of combination prevention. Yet it is an intervention with the real possibility of preventing infections, especially where other prevention options aren’t enough,” Warren said.

“Now, policy makers, regulators, advocates, WHO, UNAIDS and Gilead Sciences—the manufacturer of both TDF and TDF/FTC—must work together to determine how best to move forward to ensure that PrEP is included where appropriate in comprehensive harm reduction programs for people who inject drugs. PrEP must complement, not replace, harm reduction programs everywhere, and especially in countries and communities with significant HIV epidemics driven by injecting drugs,” Warren added.

“AVAC recognizes the altruism and commitment of the more than 2,400 trial volunteers who 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.”

More information about PrEP is available at www.avac.org/prep and www.prepwatch.org.

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.

New York, NY – Results from a large-scale HIV prevention trial among African women known as VOICE (Vaginal and Oral Interventions to Control the Epidemic) provide an urgent reminder that products must meet the needs of the people using them. While disappointing, the results lend new urgency and direction to the search for additional safe and effective HIV prevention options for women, AVAC said today.

Researchers announced today that none of three pre-exposure prophylaxis (PrEP) and microbicide interventions tested in VOICE—daily oral tenofovir, daily oral TDF/FTC (Truvada), and daily 1% vaginal tenofovir gel—provided additional protection against HIV in the study, likely because few of the women in the trial used the products as directed. This low adherence explains the lack of benefit and is consistent with data from other antiretroviral (ARV)-based prevention trials that found a correlation between higher levels of adherence and protection from HIV. The new results were presented in Atlanta at the 20th Conference on Retroviruses and Opportunistic Infections (CROI).

“The VOICE results reinforce what we already know from previous trials—these interventions work when they are used, and they don’t work when they are not used,” said Mitchell Warren, AVAC Executive Director. “PrEP is still a valuable option for many women, and men, who recognize their risk and can take PrEP consistently. Now we have a dual responsibility to understand who might benefit from daily PrEP and ensure that they can access it, and to accelerate the development of additional options that can meet the urgent needs of others.”

A range of trials has shown varying levels of effectiveness of tenofovir-based prevention for heterosexual men and women, and for men and transgender women who have sex with men. The VOICE data do not invalidate the prior trial results, including the finding that daily oral tenofovir-based PrEP provided high levels of protection for women in stable relationships where one partner was HIV-positive, and that 1% vaginal tenofovir gel was modestly effective on a different dosing schedule.

“Previous trials of tenofovir-based gel and pills have shown that biologically this approach can work, but only if the product is used. HIV prevention is never just biomedical—behavior is key. What we’ve learned from VOICE and other trials is that adherence to the prescribed dose—the behavioral component—is the variable that determines effectiveness,” Warren added.

“Biomedical tools do not work in a vacuum but rather in the complex realities of women’s and girls’ lives. The women of VOICE and other prevention trials have much to tell us. Now we need to listen to what they are saying and design prevention options based on a better understanding of their reproductive and sexual health needs and desires, their perceptions of personal risk for HIV infection, and their interest in and ability to use the products offered in those trials,” Warren said.

VOICE showed a very high incidence of HIV in the trial—5.7 percent among all the women in the trial and 8.8 percent among unmarried women under the age of 25 in South Africa.

“The high rates of new HIV infections among women, especially young women, are the most shocking and disturbing data from this trial. They are a sobering reminder of how desperately women need new prevention options that they can and will use to protect themselves from HIV,” said Elizabeth Bukusi, Deputy Director (Research and Training) of the Kenya Medical Research Institute (KEMRI) and an AVAC Board Member. “The VOICE results teach us again that an urgent need for new prevention options does not mean women will automatically demand or use those products.”

Following the 2012 US Food and Drug Administration (FDA) approval of Truvada as PrEP for adults at risk of HIV, AVAC called for a comprehensive package of PrEP demonstration projects for all populations—including young women—that could benefit from the proven option of daily oral TDF/FTC. Demonstration projects and other studies in which participants know that they are taking an intervention that has been proven to work will provide important information about how adherence can be supported in real-world situations. AVAC is also working with advocacy partners in the US and internationally to push national health agencies to systematically determine how PrEP can be delivered to the women and men who will benefit from it. This includes a statement released today from a coalition of HIV and women’s health advocates calling on US agencies to coordinate a PrEP agenda to quickly and accurately answer questions about how PrEP can be made available to women in the US.

At the same time, AVAC calls for accelerated research and development of additional HIV prevention options that are less dependent on adherence and may be easier and more desirable for women to use. These include different delivery mechanisms, such as long-acting rings and injections, and less-than-daily dosing schedules, such as that being tested in the FACTS 001 trial, which is looking at 1% tenofovir vaginal gel used around the time of sex. Renewed commitment and resources are also urgently needed for research to develop HIV vaccines, which would overcome many of the issues around adherence, and combined contraceptive and HIV prevention methods, which would address many women’s needs more comprehensively.

“The data presented today are only the beginning of what we will learn from VOICE. We need to make sure that we get all of the information we can from the VOICE participants to help us understand why women were dedicated to the trial and yet were not willing or able to use the products consistently. These women are at such high risk for HIV, we owe it to them to work with them to find the options that they can and will use to protect themselves,” Warren said.

For more information about the VOICE results and ARV-based prevention visit www.avac.org/prep and www.avac.org/microbicides. The Working Group on US Women and PrEP Statement is online at www.prepwatch.org/#women.

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.