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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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Studies Show Two-Drug Regimen of Dolutegravir and Lamivudine Has Similar Efficacy to a Three-Drug Regimen in Treatment Naïve HIV Patients

  LONDON–(BUSINESS WIRE)–ViiV Healthcare today presented at the 22nd International AIDS conference in Amsterdam 48-week results from the phase III GEMINI 1 & 2 studies, assessing the safety and efficacy of a two-drug regimen (2DR) of dolutegravir (DTG) and lamivudine (3TC) compared to a three-drug regimen of dolutegravir and two nucleoside …

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FDA Approves Janssen’s Symtuza, the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV

TITUSVILLE, N.J., July 17, 2018 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SYMTUZA™, the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults. …

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Hookipa and Gilead Partner to Develop Immunotherapies Against HIV and Hepatitis B

Vienna, Austria and Foster City, CA, 5 June 2018 – Hookipa Biotech AG (“Hookipa”), a clinical-stage biotech company pioneering an innovative class of active immunization therapies for oncology and infectious diseases and Gilead Sciences, Inc., (“Gilead”), a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet …

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FDA Expands Approval of Gilead’s Truvada to Reduce the Risk of Acquiring HIV-1 in Adolescents

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 in at-risk adolescents. The safety and efficacy profile of Truvada …

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FDA Accepts NDAs for Merck’s Investigational NNRTI for Treatment of HIV-1 Infection

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 accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults. …

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