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) .
(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].