Gador wins Chile clearance for Gilead-licensed Biktarvy



Chile’s Institute of Public Health (ISP) last week published the approval it granted to Argentina-based laboratory Gador’s Gilead-licensed anti-HIV drug Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide), according to GBI analysis. The orally-administered combination therapy is indicated for the treatment of HIV-1 infection in adults with no current or previous viral resistance to integrase inhibitors, emtricitabine, or tenofovir.

Biktarvy contains three small-molecule inhibitors (SMIs) that hinder the viral replication cycle. Integrase strand transfer inhibitor (INSTI) bictegravir blocks the critical step of transferring viral genetic material into the host’s DNA. Meanwhile, antiretrovirals emtricitabine and tenofovir inhibit the activity of HIV-1 reverse transcriptase (RT) by competing with its natural substrates, and by signalling chain termination when incorporated into nascent viral DNA.

GBI analysis reveals that approval in Chile is Biktarvy's third market approval in Latin America, following registration earlier this year in Mexico, as well as in Argentina, where it is also licensed to Gador, as GBI reported.

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