New and experimental HIV treatments: latest news

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  • 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.

    07 March 2018 | 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.

    21 February 2018 | 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.

    20 February 2018 | Mylan press release
  • 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).

    08 February 2018 | 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.

    08 February 2018 | Reuters
  • 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.

    10 January 2018 | Teva press release
  • 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.

    08 January 2018 | 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).

    08 January 2018 | Merck press release
  • HIV Drugs in the Pipeline: Expected Approvals for 2018

    Three specialty HIV medications—three oral medications and one IV formulation—are expected to receive FDA approval in 2018. All of them are combination products geared toward improving adherence.

    31 December 2017 | Infectious Disease Special Edition
  • Could we safely reduce the frequency of treatments for HIV-positive people?

    Most HIV-positive people in France under treatment take a daily dose of antiviral drugs for life. However, a major trial is currently underway that may confirm that patients could omit several days of treatment a week without risk to their health.

    08 December 2017 | The Conversation
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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

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.