Gilead's Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) Demonstrates High Efficacy and Adherence Across Diverse Patient Populations in Real-World BICSTaR Study

October 30, 2021 /BioonBIOON/ -- Gilead Sciences recently presented interim results from the ongoing multinational, observational, single-arm, non-comparative, real-world BICSTaR cohort study at the 18th European AIDS Clinical Society Conference (EACS 2021). The study enrolled 1,135Previously untreated (treatment-naïve)andPreviously treated (treatment-experienced, TE)conducted among HIV-infected individuals, aimed at evaluatingThree-in-one fixed-dose combination novel drug Biktarvy (Chinese brand name: Biktarvy®, generic name: Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, BIC/FTC/TAF)antiviral efficacy and safety. The BICSTaR study also collectedPatient-Reported Outcomes in Routine Clinical Practice, to better understand the impact of treatment on the health-related quality of life of HIV-infected individuals. The HIV-infected individuals enrolled in this study,The baseline prevalence of comorbidities is high.

In the second analysis of the BICSTaR study,After one year of treatment with Biktarvy, 97% (n=149/154) of treatment-naive adults and 96% (n=771/800) of treatment-experienced adults achieved and maintained virologic suppression (HIV-1 RNA <50 copies/mL).. Enrolled patients included adults aged 50 years or older, cisgender women, and patients with advanced disease (at baseline: CD4 count <200 cells/μL and/or ≥1 AIDS-defining event).In both the treatment-naïve and treatment-experienced groups, patient adherence to Biktarvy was high (91%, n=1032/1135).

Regarding safety, Biktarvy was generally well tolerated, with no resistance observed to any of its components. Any adverse event occurred in 148 (13%) patients, and serious adverse events occurred in 2 (<1%) patients. The most common drug-related adverse events observed to date in the BICSTaR study were weight gain (3%), nausea (1%), depression (1%), headache (1%), fatigue (1%), diarrhea (1%), and sleep disorders (1%).

Dr. Fernando Bognar, Vice President of HIV Medical Affairs at Gilead Sciences, stated: “Despite advances in antiretroviral therapy, people living with HIV continue to experience multifaceted symptoms and challenges that require person-centered care. The patient-reported outcomes observed in the BICSTaR study provide a firsthand assessment of the impact of HIV treatment and care on the quality of life of people living with HIV. As clinicians and people living with HIV seek to understand what long-term treatment means for them personally, these data presented at EAC also confirm..."Biktarvy can meet the specific treatment needs of diverse patient populations, including older men and women living with HIV and those with comorbidities.”

Biktarvy is a once-daily oral single-tablet regimen (STR) for the treatment of HIV-1 infection. It combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir (BIC) with the proven efficacy and safety of the approved drug Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg, FTC/TAF), a dual nucleoside reverse transcriptase inhibitor (NRTI) backbone regimen recommended by HIV clinical treatment guidelines. In Phase 3 clinical studies,When used in treatment-naïve patients and virologically suppressed patients switching regimens (treatment-experienced), Biktarvy achieved very high virologic suppression rates, with no treatment-emergent resistance observed.

In the United States, Biktarvy was approved for marketing in February 2018. The current indication for this drug is: as a complete regimen for the treatment of HIV-1 infection in pediatric patients (weighing ≥14 kg) and adult patients who have no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Specifically, it is indicated for: (1) treatment-naïve patients; (2) patients who have achieved virologic suppression on a stable antiretroviral regimen, to replace their current antiretroviral regimen. It should be noted that the drug label for Biktarvy includes a Boxed Warning regarding the risk of acute exacerbation of hepatitis B following treatment.

October 2021, United StatesFDAApprovalBiktarvy (BIC/FTC/TAF, 30 mg/120 mg/15 mg, low-dose tablet)Indicated for pediatric patients infected with HIV-1 weighing at least 14 kg to less than 25 kg who have achieved virologic suppression or are initiating antiretroviral (ARV) therapy. Providing a single-tablet antiretroviral regimen for children weighing at least 14 kg represents a significant milestone with the potential to save many lives. This approval expands the indication for Biktarvy to include younger pediatric patients with HIV-1 infection, which will help narrow the gap in access to HIV treatment regimens between adult and pediatric populations.

InIn China, Biktarvy® was approved in Hong Kong in October 2018 and in Mainland China in August 2019.Biktarvy® is indicated in China as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who have no evidence of current or historical viral resistance to integrase inhibitors, emtricitabine, or tenofovir. (Bioon.com)

Original Source:Clinical and Patient-Reported Outcomes in People Living With HIV on Biktarvy® in Observational BICSTaR Study Demonstrate Consistent Efficacy Profile in Real-World Setting