FDA approves first generic Truvada for HIV

FDA has approved the first generic version of Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1, in combination with other antiretroviral agents, as well as for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually acquired HIV infection in adults at high risk.

Teva Pharmaceuticals will manufacture the generic version and has reportedly reached a confidential settlement on exactly when it will roll out into the market.

Truvada is the brand name combination of emtricitabine, a synthetic cytosine analog, and tenofovir disoproxil fumarate (DF), an adenosine 5’-monophosphate analog. Each drug interferes with HIV viral RNA-dependent DNA polymerase thereby inhibiting viral replication. Emtricitabine and tenofovir DF should not be used concurrently with adefovir or lamivudine-containing products or other emtricitabine- and/or tenofovir-containing products.

The generic combination is approved for treatment of HIV-1, in combination with other antiretroviral medications, and for PrEP in adults at high risk of sexually acquired HIV infection. PrEP may be a part of a comprehensive HIV prevention plan that includes safer sex practices, such as consistent and correct condom use, regular HIV testing and risk reduction counseling. In PrEP, HIV-uninfected individuals who are at high risk of sexually-acquired HIV infection take antiretroviral medication daily to try to decrease the chance of becoming infected with HIV if exposed to the virus.

Emtricitabine and tenofovir DF used for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically thereafter. Drug-resistant HIV-1 variants have been identified with the use of emtricitabine and tenofovir DF for PrEP following undetected HIV-1 infection therefore, the medications should not be initiated in any patient for PrEP if signs or symptoms of acute HIV infection are present unless HIV-negative status is confirmed.

In clinical trials, the most common side effects associated with the use of emtricitabine and tenofovir DF in the treatment of HIV-infected individuals included diarrhea, nausea, fatigue, headache, dizziness, abnormal dreams and rash. the most common adverse reactions in PrEP patients included headache, abdominal pain, and weight loss.

Emtricitabine and tenofovir DF must be dispensed with a Medication Guide, which explains the drug’s intended uses and risks. Patients with kidney dysfunction may require less-frequent dosing and women who are HIV-positive should not breastfeed while taking emtricitabine and tenofovir DF.