The U.S. Food and Drug Administration has approved the anti-HIV drug Truvada for PrEP, the first drug to reduce the risk of HIV infection for uninfected individuals.
The FDA’s approval is for those who are at high risk of HIV infection. Truvada for PrEP, or pre-exposure prophylaxis, is strongly recommended to be used in combination with other prevention methods such as safe sex practices, risk reduction counseling, and regular HIV testing in order to reduce the risk of acquiring HIV.
A program has also been established to ensure that Truvada as PrEP will be used safely and appropriately.
The drug Truvada is a combination pill of two HIV antivirals (emtricitabine/tenofovir) that is already FDA approved for the treatment of HIV infection. Truvada as PrEP should be taken daily.
“Today’s approval marks an important milestone in our fight against HIV,” said FDA Commissioner Margaret Hamburg, M.D. “Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country.”
Others agreed that Truvada for PrEP could play a significant roll in reducing HIV transmissions.
“This approach can prevent many new infections and could dramatically impact HIV transmission worldwide as part of the tools we have available to stop the epidemic,” said Kenneth Mayer, MD, Medical Research Director of The Fenway Institute.
To approve Truvada for PrEP, the FDA strengthened the drug’s labeling. It now says that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative at least every three months before taking it. The FDA strongly recommends that the drug should not be prescribed to individuals if their HIV status is unknown.
Not all agree with the FDA’s decision. The California based AIDS Healthcare Foundation strongly disapproved.
“From the beginning we believe there was a rush to judgment by government officials and others in favor of such approval despite decidedly mixed studies offered in support,” said Michael Weinstein, the organization’s President. “And while FDA recommends a negative HIV test prior to use of Truvada as PrEP and states that use by people with an ‘unknown or HIV positive status’ is contraindicated, it in no way actually requires HIV testing in any manner—just strengthening of the Boxed Warning.”
“The FDA’s move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people,”Weinstein added.
The FDA and the drug manufacturer Gilead have established a program to minimize risk that uninfected individuals will acquire HIV or develop HIV drug resistant virus if they become infected. Called a Risk Evaluation and Mitigation Strategy (REMS), it will include training and counseling individuals who prescribe and take Truvada for PrEP. The program will emphasize the importance of adhering to the recommended dosing and understanding the risks of still becoming infected with HIV.
Gilead will also provide vouchers for free HIV testing and condoms, an opt-in service for regular reminders about HIV testing, and subsidized HIV resistance testing for any individual who becomes HIV-positive while taking Truvada for PrEP.
Efficacy for Truvada for PrEP was demonstrated in clinical trials. The level of protection varied widely depending on how consistently participants took the pills. The studies included HIV-negative high risk men and transgender women who have sex with men. In that study, those with detectable levels of the medication in their blood HIV infection rates were reduced by more than 90 percent. That study included the use of condoms, monthly HIV testing, counseling to reduce risk behavior and encourage pill dosing, and testing and treatment for sexually transmitted infections (STI).
According to heterosexual studies just published in the New England Journal of Medicine there was a 62 to 75 percent reduction in the rate of infection.
The studies still highlight the need for further research, particularly among women. Last year, the FEM-PrEP study was canceled due to the lack of efficacy among African women participants. It was later discovered that Truvada was not being properly dosed in the study. But studies also suggest that vaginal levels of the Truvada component drug tenofovir are relatively low compared with rectal levels. Women have been shown to be more susceptible to other factors influencing viral transmission including hormonal contraception. STIs and the level of a partner’s HIV virus may also adversely affect HIV transmission among women more than men. The FEM-PrEP study also showed some risk in the development of drug resistance for those who acquired HIV because they did not properly dose PrEP. So more studies are needed.
The cost of a years worth of Truvada PrEP, if taken daily, is estimated to be around $14,000.
The most common side effects include diarrhea, nausea, abdominal pain, headache, weight loss, and kidney and bone toxicity.
Courtesy of Healthy Living News