– Clinical Data Across a Diverse Range of People Living With HIV on Biktarvy Treatment in the International BICSTaR Study Showed High Effectiveness and High Levels of Adherence –
– Long-Term Switch Data Presented at EACS 2021 Further Establish the Robust and Durable Efficacy Profile of Biktarvy –
Gilead Lores,Inc. (Nasdaq GILD) moment blazoned interim results from the ongoing, transnational, experimental single-arm,non-comparative real- world cohort BICSTaR study, which is designed to estimate the antiviral effectiveness and safety profile of Biktarvy ® (bictegravir 50 mg/ emtricitabine 200 mg/ tenofovir alafenamide 25 mg tablets, B/ F/ TAF) in people living with HIV. The BICSTaR study also collected case- reported issues in routine clinical practice to more understand the impact of treatment on health- related quality of life in people living with HIV. These data were presented at the 18th European AIDS Conference (EACS 2021).
Gilead presented an analysis of case- reported issues after 12 months of treatment with Biktarvy from the BICSTaR study. During the study, conducted at spots in Europe, Canada and Israel, people living with HIV who initiated treatment with Biktarvy between June 2018 and September 2020 completed questionnaires at birth and 12 months. The questionnaires assessed case- reported issues covering a range of measures. The results accentuate the significance of collecting case- reported issues in order to understand the impact on internal health status, health- related quality of life and treatment satisfaction of people living with HIV.
“ Despite advances in antiretroviral remedy, people living with HIV experience burdensome multidimensional symptoms and enterprises taking person- centered care,” said Fernando Bognar, MD, Vice President, Medical Affairs, HIV at Gilead Lores. “ The case- reported issues observed in the BICSTaR study give a first- hand assessment of the impact of HIV treatment and care on the quality of life that people living with HIV experience. As croakers and people living with HIV look to understand what long- term treatment means to them collectively, these data presented at EACS also support that Biktarvy can meet the specific treatment requirements of different groups of people, including men and women growing with HIV and those with being comorbid conditions.”
In a alternate analysis of the BICSTaR study, 97 (n = 149/154) of treatment-naïve grown-ups and 96 (n = 771/800) of treatment-educated grown-ups achieved and maintained virologic repression (HIV-1 RNA< 50 clones/ mL) after one time of treatment. Actors included grown-ups 50 times of age or aged, cisgender women, and late presenters (CD4< 200 cells/ μl and/ or ≥ 1 AIDS- defining event at birth). Both treatment-naïve and treatment- endured actors had high continuity with Biktarvy (91, n = 1032/1135) across both groups, Biktarvy was generally well- permitted and no resistance to the factors of Biktarvy surfaced. 148 (13) actors had any adverse event and 2 (< 1) had a serious adverse event. The most common medicine- related adverse events observed to date in the BICSTaR study were weight increase (3), nausea (1), depression (1), headache (1), fatigue (1), diarrhoea (1) and sleep complaint (1). These large cohort findings continue to support the real- world effectiveness of Biktarvy across populations and are harmonious with substantiation from randomized clinical trials.
Fresh Biktarvy data presented at EACS 2021 include a Phase 3 trial ( Study 1878) that demonstrated the durable efficacity of Biktarvy. In the study, 99 of people living with HIV who switched to Biktarvy from a boosted protease asset- grounded authority maintained and achieved long- term viral repression through a standard of 101 weeks (n = 525/532), including 98 of actors withpre-existing resistance (n = 212/217; standard of 108 weeks) and 98 of actors with viral blips (n = 39/40; standard of 109 weeks), with no treatment-emergent resistance to Biktarvy. A pooled analysis of five Phase 3 studies (1844, 1878, 4030, 4449, 4580) also plant that anyhow ofpre-existing TAMS (thymidine analog- associated mutations M41L, D67N, K70R, L210W, T215Y/ F, and K219Q/ E), a high proportion of those on Biktarvy were suitable to maintain virologic repression and had an absence of treatment-emergent resistance. These data support the continued evaluation of Biktarvy as a implicit option for virologically suppressed people living with HIV with known resistance. The use of Biktarvy in individualities with a history of treatment failure or known resistance to the factors of Biktarvy is investigational, and the safety and efficacity of Biktarvy for this use haven’t been established.
Please see below for theU.S. Suggestion and Important Safety Information, including Boxed Warning, for Biktarvy.
There’s presently no cure for HIV or AIDS.
The Bictegravir Single Tablet Authority (BICSTaR) Study is an ongoing, transnational, experimental single-arm,non-comparative real- world cohort study, which aims to estimate the effectiveness, safety, tolerability, and case- reported issues of treatment with Biktarvy in treatment ‐ naïve and treatment ‐ educated people living with HIV. Among the people living with HIV enrolled in the BICSTaR study, there’s a high birth frequence of comorbidities.
Biktarvy is a complete HIV-1 treatment that combines three important drugs to form the lowest integrase beachfront transfer asset (INSTI)- grounded single- tablet authority (STR) available, offering simple once-diurnal dosing with or without food, with a limited medicine commerce eventuality and a high hedge to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy ® (emtricitabine 200 mg/ tenofovir alafenamide 25 mg tablets, F/ TAF) backbone. Biktarvy is a complete single- tablet authority and shouldn’t be taken with other HIV-1 drugs.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.
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