Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir with the demonstrated safety and efficacy profile of the Descovy (
emtricitabine 200mg/tenofovir alafenamide 25mg; FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone and is the smallest INSTI-based triple-therapy STR available.
Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir with the demonstrated safety and efficacy profile of the Descovy[R] (
emtricitabine 200mg/tenofovir alafenamide 25mg; FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone and is the smallest INSTI-based triple-therapy STR available.
The tenofovir alafenamide-based therapies include Genvoya (elvitegravir 150mg/cobicistat 15 mg/
emtricitabine 200mg/tenofovir alafenamide 10mg), Descovy (
emtricitabine 200mg/tenofovir alafenamide 10mg and 25mg) tablets and Odefsey (
emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) tablets.
Descovy, made up of
emtricitabine and tenofovir alafenamide, is a proposed indicator of pre-exposure prophylaxis in men and transgender women at high risk to HIV infection.
In addition, because
emtricitabine, the other active pharmaceutical ingredient of Truvada, faces generic competition in the European Union, Truvada also faces generic competition in the European Union and certain other countries outside of the United States.
said that the FDA has approved once-daily oral Truvada (
emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)--in combination with safer sex practices--to reduce the risk of sexually acquired HIV-1 in at-risk adolescents.
The combination of dolutegravir plus fixed-dose tenofovir disoproxil fumarate and
emtricitabine is administered as 2 pills per day.
The overall rate of resistance to
emtricitabine or tenofovir--the antiretrovirals contained in fixed-dose combination in Truvada, the only Food and Drug Administration-approved agent for HIV PrEP--was 5 cases in 9,222 trial participants, for a risk of 0.05%.
Gilead Sciences has received approval from the FDA for Odefsey (
emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) single tablet regimen for the treatment of HIV-1 infection.
Participants were randomly assigned to one of five regimens: 300 mg oral tenofovir and a placebo; oral tenofovir-emtricitabine (300 mg tenofovir and 200 mg
emtricitabine) and a placebo; two placebos; vaginal 1% tenofovir gel; or vaginal placebo gel.
The daily regimen containing
emtricitabine, tenofovir disoproxil fumarate, and rilpivirine HCl is virologically and immunologically effective, well-tolerated, and safe with benefits in the lipid profile in the majority of patients (Figure 1) [2].
Emtricitabine (5-fluoro-1-(2R, 5S)-[2-(hydroxymethyl)-1,3oxathiolan-5-yl]cytosine) (Figure 1(a)) is a potent deoxycytidine nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection [1,2].
