Gilead presents Biktarvy findings from switch studies & analysis of real-world BICSTaR study at HIV Glasgow 2020.

Gilead Sciences, Inc. announced long-term study results , which showed that people living with HIV who switched to the once-daily, single tablet regimen, Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) from a boosted protease inhibitor-based regimen consisting of atazanavir (ATV) or darunavir (DRV) plus either emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) or abacavir (ABC)/lamivudine (3TC) maintained virologic suppression (defined as HIV-1 RNA less than 50 copies/mL) with no emergent resistance, through a maximum of 156 weeks. In the study (study 1878), Biktarvy was generally well-tolerated with minimal changes to estimated glomerular filtration rate (eGFR), lipids and weight through 96 weeks. The most common drug-related adverse event was headache (two percent). The primary endpoint was at week 48; results of the open-label extension period through week 156 were presented at HIV Glasgow 2020. Additional switch data presented included a pooled analysis of six studies evaluating the efficacy of switching to Biktarvy among virologically-suppressed people living with HIV who have the most common treatment-emergent resistance mutations (M184V/I). In the analysis, of the 2,034 people living with HIV who switched to Biktarvy retrospective proviral DNA genotyping was performed on baseline samples from 90 percent (1824/2034) of study participants and preexisting M184V/I was detected in 10 percent (182/1824). In those with preexisting resistance, 98 percent (n=179/182) of participants with M184V/I maintained virologic suppression with Biktarvy at the point of last study visit (24-156 weeks), with no treatment resistance emerging. The results support the continued evaluation of Biktarvy as an effective and durable option for virologically-suppressed people living with HIV with known resistance. The use of Biktarvy in individuals with known resistance to the components of Biktarvy is investigational. Gilead also presented new findings from a Phase IIIb open-label trial showing people aged 65 years and older who switched to Biktarvy (n=86) from Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) or a TDF-based complete treatment regimen maintained high rates of virologic suppression, with no virologic failures or emergent resistance through 72 weeks. The results reinforce Biktarvy as an effective and generally well-tolerated treatment option with a high barrier to resistance in the growing population of older people living with HIV. Throughout the course of the study, there were two (two percent) Grade 3-4 study-drug related adverse events reported; no serious adverse events considered to be study-drug related were reported. Gilead also presented data from an observational, real-world, global BICSTaR study , which aims to evaluate the effectiveness, safety and patient-reported outcomes of treatment with Biktarvy in 1,400 people living with HIV in Germany, Canada, France and the Netherlands. Of the 513 participants enrolled who completed 12 months of treatment, results from the real-world clinical cohort showed effectiveness (based on virological suppression defined as HIV-1 RNA <50 copies ml) in 100 percent (n="74)" of treatment-naïve and 96 percent (n="357)" of treatment-experienced participants with available follow up at 12 months in routine clinical practice. notably, over a third of participants had more than three comorbidities at baseline. during the study, biktarvy was generally well-tolerated and no primary resistance mutations to the components of biktarvy emerged. the most common drug related adverse events were gastrointestinal (two percent) and neuropsychiatric (four percent). a preliminary, descriptive analysis of patient-reported outcomes after 12 months of treatment with biktarvy from the bicstar study was also presented at the meeting, with the results underlining the importance of collecting patient-reported outcomes in order to understand the impact on mental health status, health-related quality of life and treatment satisfaction of people living with hiv, which could inform treatment strategies for these groups.>