FDA Approves Truvada for HIV Pre-Exposure Prophylaxis

The Food and Drug Administration has approved the use of the oral once-daily combination antiviral medication Truvada for prevention in uninfected people at high risk for acquiring HIV.

Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate) has been on the U.S. market since 2004 for use in combination with other antiretroviral therapies for treatment of HIV-1 infected adults and children older than 12 years of age. The new indication, announced July 16 by the FDA, is the first ever for an HIV drug for "pre-exposure prophylaxis (PrEP)," and is to be used in combination with safer sex practices to reduce the risk of acquiring HIV infection among high-risk adults.

The studies were conducted in men who have sex with men and in heterosexual serodiscordant couples. But the new indication allows for use in other adults aged 18 years and older who are deemed to be at high risk, including those who have sex with people known to be HIV infected (who are not necessarily regular partners) and those who do not routinely use condoms, Dr. Debra Birnkrant, director of the FDA’s Division of Antiviral Products, said in a press briefing.

"These data show that treatment and new prevention methods are needed in order to have a major impact on the HIV epidemic in this country."

Truvada’s label will include new language in the boxed warning regarding the requirement for testing and documentation of a negative HIV test prior to prescribing for PrEP. Moreover, the medication will be contraindicated in people who have flulike symptoms, because that could indicate the presence of early acute but as yet undetectable HIV infection.

Testing for hepatitis B is also recommended, because worsening of hepatitis B has been reported in individuals with both HIV and hepatitis B when Truvada treatment was stopped. Individuals with a history of bone or kidney disease should be regularly monitored.

The approval comes with a risk evaluation and mitigation strategy (REMS) aimed at informing prescribers and potential users of the importance of daily use of the medication, regular HIV testing, and other infection risk-reducing measures. A training and education plan will also be made available to potential prescribers. This plan was made voluntary so as not to restrict access to Truvada for individuals who need it for HIV treatment, Dr. Birnkrant said.

Data supporting the approval of Truvada for PrEP primarily came from two large placebo-controlled trials: the Pre-Exposure Prophylaxis Initiative (iPrEx), sponsored by the National Institutes of Health and the Bill and Melinda Gates Foundation; and PartnersPrEP, sponsored by the University of Washington and funded by the Bill and Melinda Gates Foundation. In the iPrEx and PartnersPrEP trials, Truvada reduced the risk of acquiring HIV infection by 42% and 75%, respectively.

Dr. Birnkrant noted that Truvada was used in the studies in combination with other preventive strategies, such as safer sex practices, counseling, and regular testing. "Truvada alone should not be used to prevent HIV infection," she said.

About 50,000 adults and adolescents in the United States are newly diagnosed with HIV each year. While the overall rate of HIV infection has remained stable at least since 2004, the rates among men who have sex with men – particularly young minority men – have increased significantly.

"These data show that treatment and new prevention methods are needed in order to have a major impact on the HIV epidemic in this country," Dr. Birnkrant said.

The Food and Drug Administration has approved the use of the oral once-daily combination antiviral medication Truvada for prevention in uninfected people at high risk for acquiring HIV.

Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate) has been on the U.S. market since 2004 for use in combination with other antiretroviral therapies for treatment of HIV-1 infected adults and children older than 12 years of age. The new indication, announced July 16 by the FDA, is the first ever for an HIV drug for "pre-exposure prophylaxis (PrEP)," and is to be used in combination with safer sex practices to reduce the risk of acquiring HIV infection among high-risk adults.

The studies were conducted in men who have sex with men and in heterosexual serodiscordant couples. But the new indication allows for use in other adults aged 18 years and older who are deemed to be at high risk, including those who have sex with people known to be HIV infected (who are not necessarily regular partners) and those who do not routinely use condoms, Dr. Debra Birnkrant, director of the FDA’s Division of Antiviral Products, said in a press briefing.

"These data show that treatment and new prevention methods are needed in order to have a major impact on the HIV epidemic in this country."

Truvada’s label will include new language in the boxed warning regarding the requirement for testing and documentation of a negative HIV test prior to prescribing for PrEP. Moreover, the medication will be contraindicated in people who have flulike symptoms, because that could indicate the presence of early acute but as yet undetectable HIV infection.

Testing for hepatitis B is also recommended, because worsening of hepatitis B has been reported in individuals with both HIV and hepatitis B when Truvada treatment was stopped. Individuals with a history of bone or kidney disease should be regularly monitored.

The approval comes with a risk evaluation and mitigation strategy (REMS) aimed at informing prescribers and potential users of the importance of daily use of the medication, regular HIV testing, and other infection risk-reducing measures. A training and education plan will also be made available to potential prescribers. This plan was made voluntary so as not to restrict access to Truvada for individuals who need it for HIV treatment, Dr. Birnkrant said.

Data supporting the approval of Truvada for PrEP primarily came from two large placebo-controlled trials: the Pre-Exposure Prophylaxis Initiative (iPrEx), sponsored by the National Institutes of Health and the Bill and Melinda Gates Foundation; and PartnersPrEP, sponsored by the University of Washington and funded by the Bill and Melinda Gates Foundation. In the iPrEx and PartnersPrEP trials, Truvada reduced the risk of acquiring HIV infection by 42% and 75%, respectively.

Dr. Birnkrant noted that Truvada was used in the studies in combination with other preventive strategies, such as safer sex practices, counseling, and regular testing. "Truvada alone should not be used to prevent HIV infection," she said.

About 50,000 adults and adolescents in the United States are newly diagnosed with HIV each year. While the overall rate of HIV infection has remained stable at least since 2004, the rates among men who have sex with men – particularly young minority men – have increased significantly.

"These data show that treatment and new prevention methods are needed in order to have a major impact on the HIV epidemic in this country," Dr. Birnkrant said.

The Food and Drug Administration has approved the use of the oral once-daily combination antiviral medication Truvada for prevention in uninfected people at high risk for acquiring HIV.

Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate) has been on the U.S. market since 2004 for use in combination with other antiretroviral therapies for treatment of HIV-1 infected adults and children older than 12 years of age. The new indication, announced July 16 by the FDA, is the first ever for an HIV drug for "pre-exposure prophylaxis (PrEP)," and is to be used in combination with safer sex practices to reduce the risk of acquiring HIV infection among high-risk adults.

The studies were conducted in men who have sex with men and in heterosexual serodiscordant couples. But the new indication allows for use in other adults aged 18 years and older who are deemed to be at high risk, including those who have sex with people known to be HIV infected (who are not necessarily regular partners) and those who do not routinely use condoms, Dr. Debra Birnkrant, director of the FDA’s Division of Antiviral Products, said in a press briefing.

"These data show that treatment and new prevention methods are needed in order to have a major impact on the HIV epidemic in this country."

Truvada’s label will include new language in the boxed warning regarding the requirement for testing and documentation of a negative HIV test prior to prescribing for PrEP. Moreover, the medication will be contraindicated in people who have flulike symptoms, because that could indicate the presence of early acute but as yet undetectable HIV infection.

Testing for hepatitis B is also recommended, because worsening of hepatitis B has been reported in individuals with both HIV and hepatitis B when Truvada treatment was stopped. Individuals with a history of bone or kidney disease should be regularly monitored.

The approval comes with a risk evaluation and mitigation strategy (REMS) aimed at informing prescribers and potential users of the importance of daily use of the medication, regular HIV testing, and other infection risk-reducing measures. A training and education plan will also be made available to potential prescribers. This plan was made voluntary so as not to restrict access to Truvada for individuals who need it for HIV treatment, Dr. Birnkrant said.

Data supporting the approval of Truvada for PrEP primarily came from two large placebo-controlled trials: the Pre-Exposure Prophylaxis Initiative (iPrEx), sponsored by the National Institutes of Health and the Bill and Melinda Gates Foundation; and PartnersPrEP, sponsored by the University of Washington and funded by the Bill and Melinda Gates Foundation. In the iPrEx and PartnersPrEP trials, Truvada reduced the risk of acquiring HIV infection by 42% and 75%, respectively.

Dr. Birnkrant noted that Truvada was used in the studies in combination with other preventive strategies, such as safer sex practices, counseling, and regular testing. "Truvada alone should not be used to prevent HIV infection," she said.

About 50,000 adults and adolescents in the United States are newly diagnosed with HIV each year. While the overall rate of HIV infection has remained stable at least since 2004, the rates among men who have sex with men – particularly young minority men – have increased significantly.

"These data show that treatment and new prevention methods are needed in order to have a major impact on the HIV epidemic in this country," Dr. Birnkrant said.