NEW YORK, July 16, 2012 /PRNewswire-USNewswire/ -- AVAC today hailed the decision by the US Food and Drug Administration (FDA) to approve the antiretroviral drug emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada) for use as pre-exposure prophylaxis (PrEP) among sexually active HIV-negative adult men and women.
"This is a watershed moment for both US and global HIV prevention efforts," said Mitchell Warren, executive director of AVAC. "This is the first completely new biomedical HIV prevention tool to receive FDA approval in 19 years. Importantly, PrEP is a user-controlled method that greatly reduces HIV risk and does not need to be used immediately before or during sex. It has the potential to be a powerful tool for many individuals and couples struggling to remain HIV-free.
"Daily oral PrEP using TDF/FTC is absolutely not a silver bullet. It provides partial protection and is not a replacement for other prevention strategies like the male and female condom. It will not be right for everyone. It requires adherence, a confirmed HIV-negative diagnosis and ongoing monitoring.
"However, with its decision, the FDA followed the evidence from multiple trials worldwide. This evidence is clear: If you perceive yourself to be at risk, if you take your pill daily, and if you receive the drug as part of a comprehensive package of HIV prevention interventions and testing, oral PrEP using TDF/FTC can dramatically reduce your chances of becoming infected."
Gilead Sciences and the FDA developed a Risk Evaluation and Management Strategy (REMS) to help guide healthcare providers in prescribing the drug. The REMS is aimed at supporting adherence to the drug and ensuring ongoing HIV testing and other health monitoring for individuals who take PrEP.
"The REMS is a critical part of making sure daily oral TDF/FTC as PrEP is implemented correctly and most beneficially for those who need it. We look forward to reviewing the full REMS and to working with other advocates to ensure that Gilead, the FDA and others implementing PrEP ensure that it meets the needs of patients and providers," Warren added.
"This approval is one step toward ensuring that TDF/FTC as PrEP is made available to those who need it. Importantly, US approval paves the way for adding this strategy to prevention programs meeting the needs of hard-hit communities throughout the country. It is essential that the strategy be affordable and implemented in innovative, well-designed programs. But there is still much to do to ensure that PrEP is rolled out effectively where it is needed."
"Access is paramount. We will monitor and advocate that FDA approval is followed by implementation that ensures daily oral PrEP using TDF/FTC is affordable through government assistance programs, Gilead's patient assistance program and through private health insurance. State of the art HIV prevention is a right and a public health imperative, not a privilege. It is important that we explore all avenues for access and affordability of TDF/FTC as PrEP."
"We must also work quickly to ensure continued global activity aimed at optimizing the benefit of daily oral PrEP using TDF/FTC. US approval and demonstration projects should be matched by similar action in developing countries, including those where this strategy was evaluated and showed benefit. At the same time, we need to maintain and expand resources for treatment and other HIV prevention options.
"At next week's International AIDS Conference in Washington, DC, policymakers, advocates and researchers will be talking about beginning to end the AIDS epidemic. We need to be sure that there is clarity and commitment on where daily oral PrEP using TDF/FTC fits into this critical effort." Warren added.
An action agenda for daily oral PrEP using TDF/FTC
AVAC is calling for immediate actions to ensure that daily oral PrEP using TDF/FTC is introduced through programs that maximize safety, use of comprehensive HIV prevention and impact on HIV infections.
AVAC's recommendations include:
- Address cost and access issues for TDF/FTC as treatment and prevention: TDF/FTC is a well-tolerated drug with a unique resistance profile that is a preferred option for providers and people living with HIV worldwide. Access to affordable, sustainable supplies of TDF/FTC is essential. The agenda for PrEP implementation using daily oral TDF/FTC is inseparable from that of treatment access. Pricing, registration, and supply issues must be addressed.
- Additional regulatory guidance and consideration: The World Health Organization is expected to issue "rapid advice" on this PrEP strategy in the near future. This should be complemented by swift regulatory review in other countries to reduce delay in determining the appropriateness of PrEP using TDF/FTC for key epidemics.
- Demonstration projects: Real-world initiatives are urgently needed to answer important questions about how best to implement PrEP, including who can benefit most; how to provide PrEP safely and efficiently; how to integrate PrEP with other essential prevention methods such as condoms; and how to ensure high levels of adherence, given the evidence to date which includes a trial in African women which did not show benefit--with low levels of pill-taking being one likely explanation. Currently, only a limited number of demonstration projects are planned or underway.
- Public health guidance: Demonstration projects will provide key information on optimal use of daily oral TDF/FTC as PrEP. However public health entities such as the US Centers for Disease Control and Prevention, the WHO/UNAIDS, South Africa's Medicines Control Council and others can pave the way for safe and effective use through guidance on the appropriate use of daily TDF/FTC as PrEP in different populations and settings as soon as possible.
- Funding: As robust demonstration projects get underway, donors and governments should be quantifying resource needs for daily oral PrEP to be introduced as a sustained public health initiative for key populations. Funding for PrEP should not detract from other essential HIV prevention and treatment efforts. However, funders and governments should start now to quantify and identify resources for public health programming to bring daily oral PrEP using TDF/FTC to those who need it most.
- Additional research: Studies are currently underway to test PrEP in additional populations, including injecting drug users and to evaluate new drugs and less frequent PrEP dosing schedules. Trial sponsors, manufactures and regulatory agencies should stand ready to act on new data and further expand options for preventing HIV infection.
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.