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  • European Commission approves Rezolsta ® , a new once - daily , fixed - dose HIV therapy combining darunavir and cobicistat

    Janssen-Cilag International NV (Janssen) today announced that the European Commission (EC) has approved the use of REZOLSTA ® (darunavir/cobicistat) in combination with other antiretroviral (ARV) medicinal products for the treatment of human immunodeficiency virus - 1 (HIV - 1) infection in adults aged 18 years or older. "REZOLSTA ® eliminates the need to take a boosting agent in a separate tablet with once - daily darunavir, reducing the pill burden for patients," said Christiane Moecklinghoff, M.D Ph.D, Medical Director, Virology, Janssen EMEA.

    25 November 2014 | Janssen
  • HIV Drug Development Pipeline Update, Fall 2014 Edition

    HIV treatment remains far from perfect, and there are still seats at the table available for improved antiretrovirals. At IDWeek 2014 in Philadelphia, Paul Sax, M.D., made the case for this new generation of drugs, and provided an update on several of the most noteworthy candidates currently in development.

    17 November 2014 | The Body Pro
  • Innovation in fixed-dose combos: HIV/AIDS therapeutics edition

    FDC drug development is evolving rapidly as the industry gains experience in manufacturing them and ushering them through the review process. The laws have changed towards a more favorable marketing climate. And finally, it is clear that FDCs are more than a way to improve adherence—though that will always be a prominent consideration. FDCs can shift the standard of care towards a more tolerable, patient-friendly, value-oriented approach to treatment, and in the final analysis, that approach to development bodes well for companies, payers, and most importantly, patients.

    07 November 2014 | BioPharma Dive
  • Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF)-Based Single Tablet Regimen for HIV

    Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg (E/C/F/TAF) for the treatment of HIV-1 infection in adults.

    07 November 2014 | Gilead press release
  • Researchers pinpoint exactly where each building block sits in HIV

    Scientists at the European Molecular Biology Laboratory (EMBL) in Heidelberg, Germany and collaborators from Heidelberg University, in the joint Molecular Medicine Partnership Unit, have obtained the first structure of the immature form of HIV at a high enough resolution to pinpoint exactly where each building block sits in the virus. The study, published online today in Nature, reveals that the building blocks of the immature form of HIV are arranged in a surprising way.

    04 November 2014 | Medical Xpress
  • CHMP Announces Positive Opinion for REZOLSTA™, a New Once-Daily, Fixed-Dose HIV Therapy Combining Darunavir and Cobicistat

    Janssen-Cilag International NV (Janssen) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a Positive Opinion recommending REZOLSTA™ (darunavir/cobicistat) in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older. The CHMP also announced two label extensions for darunavir, a protease inhibitor marketed as PREZISTA® by Janssen.

    01 October 2014 | Janssen press release
  • Doctor treats Ebola with HIV drug in Liberia - seemingly successfully

    A doctor in rural Liberia inundated with Ebola patients says he's had good results with a treatment he tried out of sheer desperation: an HIV drug. Dr. Gobee Logan has given the drug, lamivudine, to 15 Ebola patients, and all but two survived. That's a 7% mortality rate whereas across West Africa, the virus has killed 70% of its victims.

    27 September 2014 | CNN
  • Tybost (Cobicistat) and Vitekta (Elvitegravir) Approved by FDA as Individual HIV Drugs

    A next-generation boosting agent and an integrase inhibitor joined the growing ranks of approved HIV medications on Sept. 24, when the U.S. Food and Drug Administration (FDA) stamped its seal of approval on Tybost (known generically as cobicistat) and Vitekta (elvitegravir).

    26 September 2014 | The Body
  • Gilead’s investigational tenofovir alafenamide (TAF)-based single tablet HIV regimen meets 48-week primary objective in two Phase 3 studies

    The studies demonstrated that the single tablet regimen comprising elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF), was non-inferior to Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on the proportion of patients with HIV RNA levels (viral load) of less than 50 copies/mL at 48 weeks of therapy. In addition, E/C/F/TAF demonstrated more favorable renal and bone safety compared to Stribild.

    25 September 2014 | Gilead press release
  • Gilead's Latest HIV Pill Meets Study Goals

    Gilead Sciences Inc. said its new investigational combination pill for HIV met its primary study goals in two late-stage studies, boosting prospects that the biotech company will be able to contain anticipated generic competition to one of its biggest businesses.

    24 September 2014 | Wall Street Journal
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