LONDON – Initiating antiretroviral treatment (ART) as soon as infants who are positive for HIV-1 infection are born has significant protective effects, with fewer viral reservoir cells and improved immune system development, according to new research.
Bowing to congressional pressure, the U.S. Department of Health and Human Services (HHS) Wednesday filed suit against Gilead Sciences Inc. for infringing government patents related to the use of HIV drugs Truvada and Descovy for pre-exposure prophylaxis (PrEP).
Singapore-based Vela Diagnostics Holding Pte. Ltd. has received U.S. FDA authorization via the de novo approval pathway for an in vitro diagnostic test to detect HIV-1 genomic drug resistance mutations (DRMs). The Sentosa SQ HIV-1 Genotyping Assay – the first HIV-1 genotyping next-generation sequencing (NGS) assay to win an FDA nod – uses plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase and integrase regions of the pol gene in a single test.
Singapore-based Vela Diagnostics Holding Pte. Ltd. has received U.S. FDA authorization via the de novo approval pathway for an in vitro diagnostic test to detect HIV-1 genomic drug resistance mutations (DRMs).
Gilead Sciences Inc.'s third-quarter earnings, though deemed satisfactory, brought lukewarm responses from Wall Street, with analysts such as J.P. Morgan's Cory Kasimov writing in a report that "these days the company's quarterly progress seems to take a back seat to how they [will] ultimately deploy their substantial amount of capital. The Galapagos deal notwithstanding, this feels like a long wait that's quite frankly getting a bit stale." Still reverberating is the arrangement this summer with Galapagos NV, of Mechelen, Belgium, which signed a 10-year research and development pact with Gilead under which Galapagos is getting $3.95 billion up front in hard cash plus another $1.1 billion in equity, in return for which Gilead will essentially have an option to ex-European rights on everything emanating from the firm's clinical and preclinical pipeline.
HONG KONG – Taiwan's National Health Insurance Administration has added Gilead Sciences Inc.'s Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide), a once-daily single tablet for the treatment of adults with HIV-1, to its list of reimbursed medicines.
MEXICO CITY – Merck Sharp & Dohme's MK-8591, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), impressed in both treatment and prevention studies at the 2019 International AIDS Society (IAS) Conference on HIV Science.
MEXICO CITY – Ten years after the RV144 "Thai trial" was the first to show that an effective HIV vaccine was possible, three efficacy trials for HIV vaccines are once again underway.
Durect Corp. (NASDAQ: DRXX) got a solid bump after announcing it granted Gilead Sciences Inc. exclusive worldwide rights to develop and commercialize a long-acting injectable HIV product created with Durect's platform, Saber, in a deal that could generate more than $300 million for Durect.
Getting on top of the persistent HIV epidemic requires getting ahead of new cases, but only about 7% of at-risk patients have been advised of a prophylactic drug regime approved by the FDA seven years ago. Two new studies appearing in The Lancet HIV suggest that an algorithm that uses electronic health record (EHR) data can help physicians identify their at-risk patients who are good candidates for pre-exposure prophylaxis (PrEP), thus improving the odds that modern medicine might finally put an end to the scourge of acquired immunodeficiency syndrome.
