FDA NewsPerspective

FDA approves first generic version of Truvada for treatment, prevention of HIV

The FDA recently approved the first generic version of Truvada for the treatment of HIV-1 infection, in combination with other antiretroviral agents, in adults and children weighing at least 17 kg, and for pre-exposure prophylaxis, or PrEP, in uninfected adults at high risk for infection.

The FDA announced in a press release that the generic version of Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences; FTC/TDF) is “bioequivalent and therapeutically equivalent to the reference listed drug.” It is a product of Teva Pharmaceuticals USA.

“Generic drugs approved by the FDA have the same high quality and strength as brand-name drugs,” the release said. “The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.”

According to the FDA, the most common adverse events associated with FTC/TDF among patients with HIV include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams and rash. Uninfected individuals receiving FTC/FDF for PrEP reported headache, abdominal pain and decrease in weight.

The use of FTC/TDF for a PrEP indication is not recommended for patients with signs or symptoms of HIV infection unless a negative test result is confirmed. In addition, women with HIV should not take FTC/TDF while breastfeeding, according to the FDA.

“[FTC/TDF] used for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use,” the release said. “Drug-resistant HIV-1 variants have been identified with the use of [FTC/TDF] for PrEP following undetected acute HIV-1 infection.”

 

The FDA recently approved the first generic version of Truvada for the treatment of HIV-1 infection, in combination with other antiretroviral agents, in adults and children weighing at least 17 kg, and for pre-exposure prophylaxis, or PrEP, in uninfected adults at high risk for infection.

The FDA announced in a press release that the generic version of Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences; FTC/TDF) is “bioequivalent and therapeutically equivalent to the reference listed drug.” It is a product of Teva Pharmaceuticals USA.

“Generic drugs approved by the FDA have the same high quality and strength as brand-name drugs,” the release said. “The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.”

According to the FDA, the most common adverse events associated with FTC/TDF among patients with HIV include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams and rash. Uninfected individuals receiving FTC/FDF for PrEP reported headache, abdominal pain and decrease in weight.

The use of FTC/TDF for a PrEP indication is not recommended for patients with signs or symptoms of HIV infection unless a negative test result is confirmed. In addition, women with HIV should not take FTC/TDF while breastfeeding, according to the FDA.

“[FTC/TDF] used for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use,” the release said. “Drug-resistant HIV-1 variants have been identified with the use of [FTC/TDF] for PrEP following undetected acute HIV-1 infection.”

 

    Perspective
    Paul A. Volberding

    Paul A. Volberding

    This is good news. Although many can access Truvada PrEP through drug assistance programs, it is expected that as costs fall with generic production, insurance coverage will expand. This should allow easier access to this important prevention strategy Also, the attention given the discussions about the FDA decision should increase awareness of the value PrEP may provide. This is a very good move.

    • Paul A. Volberding, MD
    • Infectious Disease News Chief Medical Editor Director, AIDS Research Institute University of California, San Francisco

    Disclosures: Volberding reports no relevant financial disclosures.