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New and experimental HIV treatments news

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Phase 3 registrational data is not sufficient for roll-out of new ARVs in low- and middle-income countries

Phase 3 randomised trials for drug approval in high-income countries do not provide sufficient evidence to support the widespread use of new antiretrovirals in low- and middle-income countries (LMICs), where the majority of people with HIV live. Key missing evidence is typically for pregnant women, people with HIV/TB coinfection and people who have not had resistance testing before starting ART.

Published
15 May 2018
From
HIV i-Base
Is Gilead’s Entire HIV Enterprise Built on a False Promise?

A new analysis finds that Gilead Sciences’ updated version of its key antiretroviral tenofovir may not actually offer any safety benefits.

Published
10 May 2018
From
Poz
European CHMP Adopts Positive Opinion for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide)

In Clinical Trials, Biktarvy Demonstrated High Efficacy and Zero Resistance Through 48 Weeks

Published
27 April 2018
From
Gilead press release
U.S. Guidelines Panel Strongly Recommends Gilead’s HIV Regimen Biktarvy

The newly approved single-tablet regimen contains the integrase inhibitor bictegravir plus emtricitabine and tenofovir alafenamide.

Published
04 April 2018
From
Poz
A Cheaper Version of Truvada Is Hitting the US Market: Here's Why It Might Not Lower Costs

Coming to U.S. pharmacies this month is Cimduo, from drugmaker Mylan. It's essentially a copycat of Truvada (TDF/FTC), but there's good reason to believe that, despite its lower price, Mylan just won't catch on. And the reasons point to the bigger issue of why it's so hard in general to bring down to earth the price of HIV drugs.

Published
04 April 2018
From
The Body
Mylan Introduces Symfi™ Triple Combo Once-Daily HIV Treatment in the U.S.

The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR).

Published
03 April 2018
From
Mylan press release
Ibalizumab-uiyk for HIV: What Pharmacists Should Know

In March 2018, the FDA approved ibalizumab-uiyk (Trogarzo, Theratechnologies), an injectable CD4-directed post-attachment HIV-1 inhibitor, indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. With its approval, ibalizumab-uiyk became the first monoclonal antibody to treat HIV. It is also the first HIV therapy with a new mechanism of action to be approved in 10 years.

Published
27 March 2018
From
Pharmacy Times
ViiV Healthcare gains CHMP Positive Opinion for Juluca (dolutegravir/rilpivirine) in Europe

The European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.

Published
23 March 2018
From
ViiV press release
FDA approves new HIV treatment for patients who have limited treatment options

Today, the U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).Trogarzo is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.

Published
07 March 2018
From
FDA
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
21 February 2018
From
CytoDyn 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.