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ViiV Healthcare Files Regulatory Submissions for First Two-Drug HIV Maintenance Regimen

GSK and ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced regulatory submissions to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir (Tivicay, ViiV Healthcare) and rilpivirine (Edurant, Janssen Sciences Ireland UC) for the maintenance treatment of HIV-1 infection.

Published
02 June 2017
From
ViiV
Gilead and GSK go head-to-head with similar HIV drug data

Gilead Sciences Inc and GlaxoSmithKline Plc will go head-to-head with rival versions of an improved class of HIV medicines, after clinical studies showed the U.S. company's new drug bictegravir was as effective as GSK's product.

Published
31 May 2017
From
Reuters
Gilead’s Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for the Treatment of HIV-1 Meets Primary Endpoint in Four Phase 3 Studies

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that four Phase 3 studies evaluating a fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) for the treatment of HIV-1 infection met their primary objectives of non-inferiority.

Published
30 May 2017
From
Gilead press release
Merck Receives CHMP Positive Opinion Recommending Approval of ISENTRESS® (raltegravir) 600 mg in the European Union

In adults and pediatric patients (weighing at least 40 kg), the recommended dosage is 1,200 mg (two 600 mg tablets) once daily for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily.

Published
22 May 2017
From
Merck press release
CHMP recommends for approval generic version of Atripla

At its May meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval a generic version of Atripla – Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (efavirenz/emtricitabine/tenofovir disoproxil) for the treatment of HIV infection.

Published
22 May 2017
From
EATG
Gilead's last chronic HIV drug — and what it plans to do now

Gilead Sciences Inc. — whose HIV-fighting drugs have helped to nearly triple the lives of people with the HIV virus and reduce the number of pills patients pop from 25 to one — expects this fall to ask government regulators to approve its final chronic HIV treatment.

Published
11 May 2017
From
San Francisco Business Times
Orphan Drug Designation for CytoDyn's PRO 140 Declined by the FDA

Cytodyn has announced that its application for Orphan Drug Designation (ODD) for PRO 140 was not granted by the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) because PRO 140 appears to have the potential to treat more than just the subset of multi-drug resistant HIV patients for which the designation was requested.

Published
18 April 2017
From
Cytodyn press release
Bone density improves in people who switch from tenofovir DF to tenofovir alafenamide

After three years, tenofovir alafenamide (TAF) for first-line HIV treatment was better at suppressing viral load and safer for the bones and kidneys than the older tenofovir

Published
27 March 2017
By
Liz Highleyman
Research helps explain how vedolizumab antibody therapy leads to sustained viral remission

HIV and its monkey cousin SIV can carry the alpha-4 beta-7 integrin receptor in their outer envelope, which helps the virus enter gut cells during early infection,

Published
23 March 2017
By
Liz Highleyman
Several new candidates in HIV drug pipeline discussed at conference

This year's Conference on Retroviruses and Opportunistic Infections (CROI 2017), held last month in Seattle, included presentations on several new investigational antiretroviral drugs in development, reflecting a more

Published
15 March 2017
By
Liz Highleyman
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Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.