The U.S. Food and Drug Administration has approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners.
Truvada, taken daily, is to be used for pre-exposure prophylaxis in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk, according to the FDA. The agency previously approved Truvada for use in combination with other antiretroviral agents for the treatment of HIV-infected adults and children ages 12 and older.
As part of PrEP, HIV-uninfected individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. A PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling and regular HIV testing.
"Today’s approval marks an important milestone in our fight against HIV," FDA Commissioner Margaret A. Hamburg, MD, said in a news release. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of common 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."
As a part of the action, the FDA has strengthened Truvada’s boxed warning to alert healthcare professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status, and the FDA strongly recommends against such use.
Truvada for PrEP is being approved with a Risk Evaluation and Mitigation Strategy to minimize the risk to uninfected individuals of acquiring HIV infection and to reduce the risk of development of resistant HIV-1 variants. The central component of the REMS is a training and education program to assist prescribers in counseling individuals who are taking or considering Truvada for PrEP. The training and education program will not restrict distribution of Truvada but will provide information about the importance of adhering to the recommended dosing regimen and understanding the serious risks of becoming infected with HIV while taking Truvada for the PrEP indication.
Truvada’s safety and efficacy for PrEP were demonstrated in two large, randomized, double-blind and placebo-controlled clinical trials. The iPrEx trial evaluated Truvada in 2,499 HIV-negative men or transgender women who have sex with men and 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 exchange of sex for commodities. Results showed Truvada was effective in reducing the risk of HIV infection by 42% compared with placebo in this population. Efficacy was strongly correlated with drug adherence.
The Partners PrEP trial was conducted in 4,758 heterosexual couples in which one partner was HIV-infected and the other was not. The trial evaluated the efficacy and safety of Truvada and tenofovir versus placebo in preventing HIV infection in the uninfected male or female partner. Results showed Truvada reduced the risk of becoming infected by 75% compared with placebo.
No new side effects were identified in the clinical trials evaluating Truvada for the PrEP indication. The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache and weight loss. Serious adverse events in general, as well as those specifically related to kidney or bone toxicity, were uncommon.
Considerations
In response to the FDA's approval, Kevin Fenton, MD, PhD, director of the Centers for Disease Control and Prevention's National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention, released a statement noting that:
• PrEP will not be right for everyone, but for some individuals at high risk for HIV infection, it may provide an important additional prevention tool.
• PrEP must be used consistently to be effective, given that the level of protection has been shown to be closely related to levels of medication adherence.
• PrEP should not be thought of a stand-alone solution. It should be provided as part of a comprehensive package of prevention services, including counseling regarding risk reduction and the importance of adherence to daily doses of PrEP medication, ready access to condoms and diagnosis and treatment of sexually transmitted infections.
• Individuals using PrEP must receive initial and regular HIV testing to confirm they do not have HIV infection, and be monitored for potential side effects.
Truvada, taken daily, is to be used for pre-exposure prophylaxis in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk, according to the FDA. The agency previously approved Truvada for use in combination with other antiretroviral agents for the treatment of HIV-infected adults and children ages 12 and older.
As part of PrEP, HIV-uninfected individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. A PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling and regular HIV testing.
"Today’s approval marks an important milestone in our fight against HIV," FDA Commissioner Margaret A. Hamburg, MD, said in a news release. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of common 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."
As a part of the action, the FDA has strengthened Truvada’s boxed warning to alert healthcare professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status, and the FDA strongly recommends against such use.
Truvada for PrEP is being approved with a Risk Evaluation and Mitigation Strategy to minimize the risk to uninfected individuals of acquiring HIV infection and to reduce the risk of development of resistant HIV-1 variants. The central component of the REMS is a training and education program to assist prescribers in counseling individuals who are taking or considering Truvada for PrEP. The training and education program will not restrict distribution of Truvada but will provide information about the importance of adhering to the recommended dosing regimen and understanding the serious risks of becoming infected with HIV while taking Truvada for the PrEP indication.
Truvada’s safety and efficacy for PrEP were demonstrated in two large, randomized, double-blind and placebo-controlled clinical trials. The iPrEx trial evaluated Truvada in 2,499 HIV-negative men or transgender women who have sex with men and 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 exchange of sex for commodities. Results showed Truvada was effective in reducing the risk of HIV infection by 42% compared with placebo in this population. Efficacy was strongly correlated with drug adherence.
The Partners PrEP trial was conducted in 4,758 heterosexual couples in which one partner was HIV-infected and the other was not. The trial evaluated the efficacy and safety of Truvada and tenofovir versus placebo in preventing HIV infection in the uninfected male or female partner. Results showed Truvada reduced the risk of becoming infected by 75% compared with placebo.
No new side effects were identified in the clinical trials evaluating Truvada for the PrEP indication. The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache and weight loss. Serious adverse events in general, as well as those specifically related to kidney or bone toxicity, were uncommon.
Considerations
In response to the FDA's approval, Kevin Fenton, MD, PhD, director of the Centers for Disease Control and Prevention's National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention, released a statement noting that:
• PrEP will not be right for everyone, but for some individuals at high risk for HIV infection, it may provide an important additional prevention tool.
• PrEP must be used consistently to be effective, given that the level of protection has been shown to be closely related to levels of medication adherence.
• PrEP should not be thought of a stand-alone solution. It should be provided as part of a comprehensive package of prevention services, including counseling regarding risk reduction and the importance of adherence to daily doses of PrEP medication, ready access to condoms and diagnosis and treatment of sexually transmitted infections.
• Individuals using PrEP must receive initial and regular HIV testing to confirm they do not have HIV infection, and be monitored for potential side effects.
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