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Gilead’s single tablet regimen Odefsey receives European marketing approval for HIV treatment

The European Commission has granted marketing authorization for Gilead Sciences' once-daily single tablet regimen (STR) 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.

Published
5 hours ago
From
PharmaBiz
Investigational Integrase Inhibitor Bictegravir Safe and Effective Against HIV in Early Study

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.

Published
21 June 2016
From
The Body
Frontier Biotech's Long-acting HIV-1 Fusion Inhibitor Albuvirtide Meets 48-Week Primary Objective: Interim Results of a Phase 3 Trial

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.

Published
07 June 2016
From
Frontier Biotech press release
Botswana gets GSK's modern HIV drug in largest ever Africa tender

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.

Published
03 June 2016
From
Reuters
European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV

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.

Published
25 April 2016
From
Gilead press release
ViiV Healthcare, Medicines Patent Pool Extend Licence for Dolutegravir to All Lower Middle-Income Countries

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.

Published
25 April 2016
From
ViiV Healthcare press release
U.S. Food and Drug Administration Approves Descovy® (Emtricitabine, Tenofovir Alafenamide), Gilead’s Third TAF-Based HIV Therapy

-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.

Published
05 April 2016
From
Gilead press release
Long-acting oral antiretroviral MK-8591 could represent 'paradigm shift' in HIV treatment and prophylaxis

An investigational antiretroviral agent that maintains drug levels that are able to inhibit HIV up to six months after dosing could represent a “paradigm shift” in HIV

Published
01 April 2016
By
Michael Carter
Gene therapy snips HIV out of infected cells and makes uninfected cells resistant

For the first time, researchers have used a gene-editing technique already used to produce cells resistant to HIV infection to target HIV-infected cells. They have managed

Published
30 March 2016
By
Gus Cairns
Combination inhibitor BMS-986197 demonstrates good activity against HIV in early study

A long-acting bio-engineered molecule with a triple mechanism of action demonstrated potent antiviral activity and worked against HIV that developed resistance to any one of the three

Published
18 March 2016
By
Liz Highleyman
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