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
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
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
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 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
Gilead is running nine phase III studies involving tenofovir alafenamide (TAF), which reflects the importance of the drug to Gilead's future HIV business. It is collecting an enormous amount of clinical data in which to make the case that TAF should be a preferred backbone drug for new and existing HIV patients, as well as patients who cannot use Viread because of pre-existing kidney conditions.
23 September 2014 | The Street
Janssen Inc. announced today that PREZCOBIX™ (darunavir/cobicistat), a once-daily, oral medication for the treatment of HIV infection in combination with other antiretroviral agents, is now available in Canada. The new treatment option combining a protease inhibitor with a boosting agent reduces the number of pills required to manage HIV.
18 September 2014 | Newswire.ca
Cobicistat-boosted darunavir plus tenofovir alafenamide (TAF) and emtricitabine (FTC) yielded less bone and renal toxicity than darunavir/cobicistat plus tenofovir/emtricitabine (TDF/FTC) in randomized a phase 2 trial.
16 September 2014 | NATAP
HIV drugs which only need to be taken once a month are to be developed at the University of Liverpool in a bid to overcome the problem of ‘pill fatigue’.
15 September 2014 | University of Liverpool press release
America’s biopharmaceutical research companies are currently developing 44 medicines and vaccines for HIV/AIDS treatment and prevention, according to the latest Medicines in Development report by the Pharmaceutical Research and Manufacturers of America (PhRMA).
11 September 2014 | Pharmaceutical Research and Manufacturers of America