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.”