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New and experimental HIV treatments news

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CytoDyn Reports Primary Endpoint Achieved in PRO 140 Pivotal Combination Therapy Trial in HIV Infection

CytoDyn Inc. (OTC.QB:CYDY) reports the successful achievement of the primary endpoint in its CD02 Phase 2b/3 pivotal clinical trial with PRO 140 in combination with existing antiretroviral therapy (ART) in patients failing their current HIV therapy. The trial data show a statistically significant reduction in HIV-1 RNA viral load of greater than 0.5log with PRO 140 versus placebo. CytoDyn is developing PRO 140, a humanized CCR5 monoclonal antibody, to combat human immunodeficiency virus (HIV) infection and certain immunologic disorders.

Published
11 hours ago
From
CytoDyn press release
Mylan (MYL) Announces Tentative Approval for Combination HIV Treatment DTG/FTC/TAF Under FDA's PEPFAR Program

Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced receipt of tentative approval from the U.S. Food and Drug Administration (FDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. The antiretroviral (ARV) will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS.

Published
20 February 2018
From
Mylan press release
US regulators approve new HIV combo pill containing bictegravir

The US Food and Drug Administration (FDA) yesterday approved Biktarvy, Gilead Sciences' new single tablet antiretroviral regimen containing the HIV integrase inhibitor bictegravir, which was highly effective

Published
08 February 2018
By
Liz Highleyman
ViiV Healthcare launches eighth phase III study in two-drug regimen programme for HIV-1 treatment

Today ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced the start of a phase III study designed to establish if adults with HIV-1 with current virologic suppression on a tenofovir alafenamide fumarate (TAF)-based regimen of at least three drugs are able to maintain viral suppression upon switching to a two-drug regimen (2DR) of dolutegravir (TIVICAY) and lamivudine (EPIVIR).

Published
08 February 2018
From
ViiV press release
US FDA approves Gilead triple HIV drug, rival files lawsuit

The U.S. Food and Drug Administration on Wednesday approved Biktarvy, Gilead Sciences Inc’s once-daily, triple-combination tablet for treatment of HIV infection, paving the way for the biotech company to capture more of the multibillion-dollar HIV drug market.

Published
08 February 2018
From
Reuters
Long-acting injectable ARVs are convenient and private, study participants report

HIV-positive people who took injectable cabotegravir + rilpivirine every four or eight weeks as antiretroviral therapy found it more convenient and discreet than daily pills, also feeling

Published
17 January 2018
By
Roger Pebody
Teva Announces Exclusive Launch of a Generic Version of Reyataz® in the United States

Reyataz® had annual sales of approximately $402 million in the U.S., according to IMS data as of October 2017.

Published
10 January 2018
From
Teva press release
New 'mini-pillbox' device could deliver three HIV drugs in a single once-weekly dose

A new oral device that is taken once a week in a capsule could deliver two or three antiretroviral drugs and significantly reduce the risk

Published
09 January 2018
By
Keith Alcorn
New long-acting, less-toxic HIV drug suppresses virus in humanized mice

A team of Yale researchers tested a new chemical compound that suppresses HIV, protects immune cells, and remains effective for weeks with a single dose. In animal experiments, the compound proved to be a promising new candidate to enhance current HIV treatment regimens — without increasing toxic side effects, the researchers said.

Published
08 January 2018
From
Yale News
FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection

The NDAs include data for doravirine (DOR) as a once-daily tablet for use in combination with other antiretroviral agents, and for use of doravirine with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a once-daily fixed-dose combination single tablet as a complete regimen (DOR/3TC/TDF).

Published
08 January 2018
From
Merck press release
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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.