by James Whitely -
SGN Staff Writer
On July 16, the Food and Drug Administration (FDA) approved the anti-retroviral drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for use by HIV-negative individuals to lower their risk of infection. It is the first drug ever approved for such use.
Truvada can now be prescribed to reduce the risk of HIV infection in uninfected individuals who are at high risk of contracting HIV, such as those who engage in sex with infected partners. Taken daily, Truvada is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices such as risk reduction counseling and regular HIV testing.
'Today's approval marks an important milestone in our fight against HIV,' said FDA Commissioner Margaret Hamburg. '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.'
'Today's decision by the FDA heralds a new era in HIV prevention - one with great promise for expanded access to HIV testing and prevention counseling and support,' said Neil Giuliano, CEO of the San Francisco AIDS Foundation. 'The approval paves the way for increased work with the federal government and Gilead Sciences [the drug's manufacturer] to ensure they realize the incredible impact they can now have to get Truvada to the communities that stand to benefit most, especially Gay men and people of color.'
As a part of the approval, the FDA stated that Truvada's boxed warning must alert health care professionals and uninfected individuals that Truvada for PrEP must be used only by individuals who are confirmed to be HIV-negative. The drug is contraindicated for PrEP in individuals whose HIV status is unknown or positive, and the FDA strongly discourages such use. Consequently, the FDA recommends that patients be tested for HIV before receiving the drug, and then at three-month intervals for the duration of its use.
Truvada's safety and efficacy for PrEP were demonstrated in two large, randomized, double-blind, placebo-controlled clinical trials.
One three-year trial evaluated Truvada in 2,499 HIV-negative men and Trans women who have sex with men who show evidence of high-risk behavior for HIV infection, such as inconsistent or no condom use during sex with a partner of positive or unknown HIV status; a high number of sex partners; and/or exchange of sex for commodities. Results showed Truvada was 42% more effective in reducing the risk of HIV infection than the placebo.
'This approval is a major milestone in our 30-year fight against AIDS,' said Dr. Robert M. Grant of the University of California at San Francisco, lead investigator of the MSM/TWSM trial. 'The use of PrEP alongside routine HIV testing gives us a tremendous opportunity to reduce the rate of new HIV infections in this country and around the world.'
Another trial was conducted with 4,758 heterosexual sero-discordant couples (in which one partner is HIV-positive and the other isn't). Results showed Truvada reduced the risk of infection by 75 percent.
'The data clearly demonstrate that Truvada as pre-exposure prophylaxis is effective at reducing the risk of HIV infection acquired through sexual exposure,' said Dr. Connie Celum of the University of Washington, lead investigator of the heterosexual trial. 'It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections as part of a combination HIV prevention strategy.
'Although the implementation of PrEP will bring challenges, they can be anticipated and systems developed to address these challenges. In particular, systems to provide comprehensive education and support to health care providers and people who use PrEP will be required to ensure appropriate and effective use of this potentially groundbreaking new HIV prevention intervention,' Celum added.
'The groundbreaking decision by the FDA has widespread implications for efforts to stop the spread of HIV both here in the United States and beyond our borders,' said James Loduca, vice president of public affairs for the San Francisco AIDS Foundation. 'Now the hard work begins to ensure that health care providers, clinics, and our community know how and when to use Truvada - and to ensure that price and delivery systems are never a barrier to access for anyone who stands to benefit from it.'
However, not everyone is cheering the FDA's decision.
'The FDA's approval of Gilead's Truvada as a form of HIV prevention today, without any requirement for HIV testing, is completely reckless and a move that will ultimately set back years of HIV prevention efforts,' said Michael Weinstein, president of the AIDS Healthcare Foundation.
'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. 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 on Gilead's packaging. 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.'
The most common side effects associated with Truvada include abdominal pain, diarrhea, headache, nausea, and weight loss. Serious adverse side effects are uncommon.
The AIDS Healthcare Foundation also said Truvada's use as a preventive measure could give patients a false sense of security and reduce the use of condoms, the most reliable form of protection against HIV.
FDA scientists said Monday said there was no indication from the trials that users were more likely to engage in risky sexual behavior.
'What we found was that condom use increased over time and sexually transmitted infections either remained at baseline levels or decreased,' said Dr. Debra Birnkrant, the FDA's director of antiviral products. 'So in essence, we don't have any strong evidence that condoms were not used or there was a decrease in condom use.'
Gilead Sciences has marketed Truvada since 2004 as a treatment for people who are already infected with HIV. Until now, Truvada has most commonly been used in combination with other antiretroviral agents for the treatment of HIV infection in adults and children over 12. However, because Truvada is used to manage HIV, some doctors already prescribe it as a preventive measure. The FDA approval will allow Gilead to formally market the drug for that use, which could dramatically increase prescribing.
Truvada is expected to cost at least $13,900 a year for treatment in the U.S., according to Gilead Sciences.
'Today's decision is the culmination of almost 20 years of research involving investigators, academic and medical institutions, funding agencies, and nearly 20,000 trial participants around the world, and Gilead is proud to have been a partner in this effort,' said Dr. Norbert Bischofberger, Gilead's executive vice president of research and development, and also the company's chief scientific officer.
'This advancement in the field of HIV prevention was made possible due to the leadership and commitment of the FDA and the Department of Health and Human Services to reduce the number of new HIV infections in the United States and worldwide.'
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