Gilead Sciences Presents Findings from Clinical Studies Evaluating Patients Who Switched to Biktarvy(R) at 2020 Asia Pacific AIDS & Co-infections Conference
HONG KONG, Oct. 16, 2020 /PRNewswire/ -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced findings from multiple studies in Asian population that evaluated the safety and efficacy of switching to once-daily, single tablet regimen, Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) from baseline regimens at the 2020 Asia Pacific AIDS & Co-Infections Conference (APACC).
A post-hoc pooled analysis from three studies demonstrated efficacy of switching to B/F/TAF from integrase strand transfer inhibitor (INSTI) based antiretroviral therapy, or a boosted protease inhibitor (PI) with two Nucleotide Reverse Transcriptase Inhibitors (NRTIs) baseline regimens, among virologically-suppressed Asian adults living with HIV. In the analysis, 100 percent of the 63 Asian adults who switched to B/F/TAF maintained virologic suppression (defined as HIV-1 RNA <50 copies/mL) with no emergent resistance, vs 95.9 percent (70/73) in those stay on baseline regimen (SBR) group, through a maximum of 48 weeks. B/F/TAF was well tolerated with no adverse events leading to discontinuation among Asian participants in the studies.
Similarly, an open-label, randomized, phase 3 study of women with HIV who were virologically suppressed (HIV-1 RNA < 50 copies/mL) on a baseline regimen (elvitegravir (E)/cobicistat (C)/F/TAF, E/C/F/tenofovir disoproxil fumarate (TDF), or atazanavir + ritonavir + F/TDF), found that virologic suppression was maintained in 100 percent of the subgroup of Asian women participants (n=48) vs 98 percent in the SBR group (53/54). B/F/TAF was well tolerated with no adverse events leading to discontinuation.
"These results further demonstrate the well-established efficacy and safety profile of Biktarvy. No participant on B/F/TAF developed treatment-emergent resistance. The additional data can further support healthcare providers in making the appropriate treatment choice for HIV patients in Asia," said Dr Kuan-Yeh Lee, Director of HIV Medical Affairs, Asia, Gilead Sciences.
Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; B/F/TAF) is approved in Hong Kong, Singapore, South Korea, Taiwan and Thailand as a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults. B/F/TAF is indicated for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir*.
*Please refer to specific country label. In Singapore and Taiwan, Biktarvy is also indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 25kg.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company's website at www.gilead.com.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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