Biktarvy China approval : US biopharma company Gilead Sciences said that the China National Medical Products Administration (NMPA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF) for the treatment of HIV-1 infection.
The once-daily single tablet regimen (STR) Biktarvy is a combination of the unboosted integrase strand transfer inhibitor (INSTI) bictegravir and the dual nucleoside reverse transcriptase inhibitor (NRTI) Descovy (emtricitabine 200mg/tenofovir alafenamide 25mg; FTC/TAF). It is the smallest INSTI-based triple-therapy single tablet regimen to be available, said Gilead Sciences.
In China, Biktarvy has been approved for HIV-1 treatment in adults without any existing or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
Commenting on Biktarvy China approval, Taisheng Li – Director of Infectious Disease Department at Peking Union Medical College Hospital said: “Biktarvy offers high rates of efficacy, high barriers to resistance and a demonstrated tolerability profile, underscoring its role as an important new treatment option for a broad range of patients in China.”
The Biktarvy China approval was driven by the findings of four ongoing phase 3 clinical trials – two in treatment-naïve HIV-1 infected adults, and the other two in virologically suppressed adults.
The clinical trials featured a diverse population of 2,414 participants on Biktarvy or an active comparator regimen, including a broad range of adult age groups and races/ethnicities.
Biktarvy achieved its primary efficacy objective of non-inferiority at 48 weeks in all the four phase 3 clinical trials. During the 48 weeks of treatment, none of the enrolled patients in any of the four clinical trials developed treatment-emergent virologic resistance while taking Biktarvy, and none of them stopped the single tablet regimen because of renal, bone or hepatic adverse events.
Diana Brainard – Senior Vice President of Gilead Sciences HIV and Emerging Viruses commenting on Biktarvy China approval said: “Gilead is pleased that people living with HIV in China will now have our newest HIV treatment innovation as a treatment option.
“The approval of Biktarvy in China represents a meaningful new option for HIV treatment and the speed with which it has been approved is a testament to China’s commitment to bringing the latest innovations to people with urgent medical need.”
In January 2018, Gilead Sciences secured Biktarvy EMA approval in Europe and in the following month bagged Biktarvy FDA approval for the treatment of HIV-1 infection.
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