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FDA Approves ViiV’s Dovato, the First, Once-Daily, Single-Tablet, Two-Drug Regimen for Treatment-Naïve HIV-1 adults

LONDON–(BUSINESS WIRE)–ViiV Healthcare today announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to …

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Gilead Submits sNDA to the FDA for Once-Daily Descovy for HIV Pre-Exposure Prophylaxis

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired …

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Janssen Presents Positive Long-Term Efficacy and Safety of Symtuza in Treatment-Naïve Adults with HIV-1

GLASGOW, Scotland–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson today unveiled 96-week results from the pivotal Phase 3 AMBER study of SYMTUZA® (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (D/C/F/TAF)) at HIV Glasgow in Scotland. D/C/F/TAF is a once-daily darunavir-based single-tablet regimen (STR), …

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Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy for Treatment of HIV-1 in Treatment-Naïve Adults

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced 96-week results from a Phase 3, randomized, double-blinded study (Study 1490) evaluating the safety and efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, BIC/FTC/TAF) for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing study, …

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AELIX and Gilead Collaborate to Evaluate a Therapeutic Vaccine and TLR7 Agonist Regimen for HIV Cure

BARCELONA, Spain–(BUSINESS WIRE)–AELIX Therapeutics S.L. (“AELIX”), a clinical-stage biotechnology company specialized in the discovery and development of immunotherapies for HIV infection, today announces that it has entered into a clinical research collaboration with Gilead Sciences, Inc. (“Gilead”), a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas …

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Merck’s Delstrigo Meets Primary Efficacy Endpoint in Phase 3 Study in Patients with HIV

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the first presentation of data from the Phase 3 DRIVE-SHIFT trial evaluating a switch of medication to DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil …

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Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy for the Treatment of HIV-1 in Adults New to HIV Therapy

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced 96-week results from a Phase 3, randomized, double-blinded study (Study 1489) evaluating the safety and efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing study, Biktarvy …

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FDA Approves Merck’s Destrigo and Pifeltro, Two New Drugs for Treatment of HIV

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved two new HIV-1 medicines: DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 …

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Janssen Reports Positive Topline Results for Phase 3 Study of Long Acting Injectable Two-Drug Regimen for Treatment of HIV

CORK, Ireland, Aug. 15, 2018  /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today confirmed positive topline results from the global, Phase III Antiretroviral Therapy as Long-Acting Suppression (ATLAS) study of the first investigational long-acting injectable two-drug regimen (2DR) for the treatment of HIV-1. The ATLAS study results …

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Gilead Announces Data Showing that States with Highest Use of Truvada for PrEP had Significant Declines in New HIV Infections

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced results of a retrospective nationwide analysis of the impact of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets) for pre-exposure prophylaxis (PrEP) use across all 50 U.S. states and the District of Columbia. Conducted in collaboration with researchers …

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