A new integrase inhibitor known as bictegravir (BIC, GS-9883) was found to be well tolerated and effective as HIV treatment in a 10-day monotherapy study, warranting further investigation of the drug, according to research presented at ASM Microbe 2016 in Boston, Massachusetts.
21 June 2016 | The Body
Frontier Biotechnologies Inc. today reported that a phase 3 clinical trial (TALENT Study) of its lead product albuvirtide meets primary objective based on an interim analysis. The results demonstrated that once-weekly given albuvirtide plus ritonavir-boosted lopinavir was non-inferior to WHO-recommended second-line three-drug regimen (control) at 48-week in treatment experienced HIV-1 infected adults. In addition, patients administered with albuvirtide showed statistically better renal safety than those taking the control regimen containing tenofovir disoproxil fumarate.
07 June 2016 | Frontier Biotech press release
ViiV Healthcare, which is majority-owned by GSK, said on Friday it was the first time that Tivicay, or dolutegravir, was being made available as a first-line treatment as part of a national health program in sub-Saharan Africa.
03 June 2016 | Reuters
Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for two doses of Descovy® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection. Descovy is Gilead’s second TAF-based therapy to receive marketing authorization in the European Union.
25 April 2016 | Gilead press release
The Medicines Patent Pool (MPP) and ViiV Healthcare announced an extension of their current licensing agreement today to increase access to dolutegravir (DTG), a promising new antiretroviral, to cover all remaining lower middle-income countries. The amendment to the 2014 licence specifically allows generic medicine distribution in four countries with patents - Armenia, Moldova, Morocco and Ukraine - that were not covered in the initial agreement. MPP sub-licensees can now sell in countries that are home to 94% of people living with HIV in the developing world.
25 April 2016 | ViiV Healthcare press release
-Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.
05 April 2016 | Gilead press release
The HIV community has a lot of information to digest after an annual CROI (Conference on Retroviruses and Opportunistic Infections) conference. BETA wanted to distill some of these important findings by asking some prominent San Francisco Bay Area providers to give us their take on the conference. We asked, “What did you find interesting? What did you find exciting? And, what did you learn?”
03 March 2016 | BETA blog
ABX464 is an orally available therapeutic that blocks HIV replication through an entirely novel mechanism, i.e. the modulation of the biogenesis of viral RNA, and acts by targeting the Rev protein.
02 March 2016 | Abivax press release
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients.
02 March 2016 | Gilead press release
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for two doses of Descovy® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), an investigational fixed-dose combination for the treatment of HIV-1 infection in adults and adolescents (ages 12 years and older with body weight at least 35 kg) in combination with other HIV antiretroviral agents.
26 February 2016 | Gilead press release