Truvada is a fixed-dose combination tablet combining 200mg FTC (emtricitabine) and 245mg tenofovir. It is manufactured by Gilead Sciences. FTC is a nucleoside reverse transcriptase inhibitor (NRTI) and tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI). These drugs reduce the amount of HIV in the body.
The standard dose of Truvada is one tablet once a day, with or without food, in combination with at least one other anti-HIV drug. It is licensed for use in adults over 18 years of age. Its European licence was granted in February 2005 and it was licensed in the United States in August 2004.
The approval of Truvada was based on studies showing that taking the combination tablet produced levels of FTC and tenofovir that are similar to the constituent drugs of tenofovir (Viread) and FTC (Emtriva) taken separately, as well as on studies showing the effectiveness of the two drugs. (Pozniak) The safety, resistance, and effectiveness of the combination were also extrapolated from previous studies of tenofovir and 3TC (lamivudine, Epivir). Emtricitabine is regarded as sufficiently similar to 3TC by regulatory authorities that it could be treated as a substitute for the purposes of approval.
The 48-week data presented from the HEAT study in 2008 showed that safety, efficacy, and side-effect profiles of Kivexa and Truvada (emtricitabine/FTC + tenofovir) had similar rates of viral suppression and were well tolerated. (Smith)
Truvada’s constituent drugs have not been assessed in pregnant women, so it is not recommended for use during pregnancy unless the potential benefit outweighs the risk.
Pozniak AL et al. Superior outcome for tenofovir DF (TDF), emtricitabine (FTC) and efzvirenz (EFV) compared to fixed dose zidovudine / lamivudine (CBV) and EFV in antiretroviral naive patients. Third International AIDS Society Conference on HIV Pathogenesis and Treatment, Rio de Janeiro, abstract WeOa0202, 2005.
Smith KY et al. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS, 23: 1547-1556, 2009.