Antiretroviral Therapy

In July 2020, the U.S. Food and Drug Administration approved fostemsavir (FTR) for treatment of people with multi-drug resistant HIV-1 whose current ARV regimen is failing because of resistance, intolerance, or safety issues. FTR is a novel attachment inhibitor that binds the HIV envelope...

In 2018, initial results from the Tsepamo study of birth outcomes in Botswanan women treated with ART during pregnancy raised questions about the safety of dolutegravir (DTG) when given at the time of conception or very early in pregnancy. Specifically, an early interim analysis found a higher...

In April 2019, the U.S. Food and Drug Administration approved a combination pill comprising the integrase inhibitor dolutegravir (DTG), 50 mg, and the NRTI lamivudine (3TC), 300 mg, for use as a complete ARV regimen for initial HIV treatment of patients. The approval specifies that DTG/3TC is...

Two pharmacokinetic studies from AIDS 2018 help elucidate the disposition of tenofovir alafenamide (TAF) and cobicistat-boosted darunavir during pregnancy.

The IMPAACT P1026s study examined plasma concentrations of TAF with and without cobicistat in 43 pregnant women. For women taking...

The U.S. Food and Drug Administration has given approval to a coformulation of darunavir 800 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 10 mg, to be marketed under the brand name Symtuza. DRV/COBI/FTC/TAF constitutes a complete regimen for patients with susceptible HIV...

The EMERALD Study is a Phase III, open-label, noninferiority study in which 1,141 patients with stable HIV suppression on a regimen comprising a boosted protease inhibitor plus TDF/FTC were randomized (2:1) to either switch to an investigational single-tablet regimen containing...

Bictegravir (BIC), a new integrase inhibitor, was recently approved by the FDA for use in a single-pill coformulation with TAF/FTC (brand name: Biktarvy) as initial therapy and as a switch regimen for patients who are already on a suppressive ART regimen and who have no history of...

Doravirine (DOR) is an investigational NNRTI that currently is being developed in a coformulation with TDF and FTC. A Phase 3 comparison of DOR + 2 NRTIs (87% of study subjects were given TDF/FTC) and DRV/r + 2 NRTIs in initial therapy was presented at CROI earlier this year (DRIVE-FORWARD); the...

Bictegravir (BIC) is an investigational integrase inhibitor that is being studied as part of a coformulation with tenofovir alafenamide (TAF) and emtricitabine (FTC). Two Phase 3 trials comparing a single-tablet regimen of BIC/TAF/FTC (50/25/200 mg) with regimens containing dolutegravir (DTG)...

Leading up to this year, some researchers and clinicians had optimistically viewed dolutegravir an invincible ARV, a drug so mighty that it was unlikely to fail, and even more unlikely to be victim to emergent resistance mutations. Two presentations at CROI demonstrated the...

The PARTNER Study, a multisite European study, evaluated rates of HIV transmissions within serodifferent heterosexual and MSM couples (n = 548 and n = 340, respectively, contributed eligible data). The HIV-positive partners were on ART with HIV RNA levels of <200 copies/mL, and the couples...

Three studies presented at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) explored the pharmacokinetics of antiretrovirals administered during pregnancy. These studies support the use of standard-dose efavirenz, once-daily dolutegravir, and BID ritonavir-boosted...

There was a pharmacokinetic study presented at the Conference on Retroviruses and Opportunistic Infections in Boston in February. It evaluated concentrations of tenofovir (TFV) and TFV-diphosphate (DP) in genital and rectal tissue. Also in anogenital fluid samples after administration of oral...