Four-Year Biktarvy® Data Presented at IAS 2021 Demonstrate High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults
Jul 19, 2021 01:39
CST Updated
01:39
Gilead Sciences
Antiviral Drug Developer
July 19, 2021 /BioonBIOON/ -- Gilead Sciences recently at the 11th International AIDS Society (IAS) Conference on HIV Science in 2021Conferencepresented the pooled analysis data from the 48-week open-label extension (OLE) period of two randomized, double-blind, active-controlled Phase III studies (Studies 1489 and 1490) for the novel three-drug fixed-dose combination Biktarvy (Chinese brand name: 必妥维®, generic name: bictegravir/emtricitabine/tenofovir alafenamide tablets, bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, BIC/FTC/TAF).
Biktarvy is a guideline-recommended single-tablet regimen for patients with HIV-1. Pooled analysis data show that,In HIV-1-infected adults who have not previously received HIV treatment (treatment-naive)，Biktarvy treatment for 4 years (192 weeks) demonstrated high efficacy and durable viral suppression, with 99% of patients achieving and maintaining virologic suppression, and no cases of treatment-emergent resistance to any component of Biktarvy were observed.
In two studies, 1,274 treatment-naïve adult patients were randomized to receive Biktarvy (n=634) or a dolutegravir (DTG)-based triple regimen (n=640) for 144 weeks. In Study 1489, the DTG triple regimen consisted of dolutegravir/abacavir/lamivudine (50/600/300 mg; DTG/ABC/3TC); in Study 1490, the DTG triple regimen consisted of DTG + emtricitabine/tenofovir alafenamide (50/200/25 mg; DTG+F/TAF). The primary endpoint for both studies was the virologic suppression rate at Week 48.
Previously reported data indicated that both studies met their primary endpoints at Week 48: in treatment-naïve adults with HIV-1 infection, Biktarvy demonstrated non-inferior efficacy compared to two dolutegravir (DTG)-based triple regimens (DTG/ABC/3TC and DTG + F/TAF). Treatment outcomes were also evaluated at Week 144, similarly confirming the non-inferior efficacy of Biktarvy versus the two DTG-based triple regimens: patients in both groups achieved undetectable viral loads, and no treatment-emergent resistance was observed. Following unblinding after 144 weeks of treatment, all patients entered an open-label extension (OLE) phase to receive Biktarvy for up to 96 weeks. Both studies are currently ongoing.
4-Year Treatment Data in Treatment-Naïve Adult Patients
At this conference, pooled results were presented for patients from initial randomization to Biktarvy treatment through Week 192 (Week 144 + Week 48) across two studies, specifically the pooled results at Week 48 of the open-label extension (OLE) phase. The data show that,Through 4 years (192 weeks, n=476/480, missing=excluded) of follow-up, 99.2% of patients maintained an undetectable viral load (i.e., virologic suppression, HIV-1 RNA <50 copies/mL).、The median CD4 cell count increased by 289 cells/μL from baseline, with no patients experiencing treatment failure due to resistance.
Regarding safety, 79% of treatment-emergent adverse events (TEAEs) were Grade 1 or 2, with the most common being diarrhea, nasopharyngitis, headache, upper respiratory tract infection, and syphilis. Adverse events led to treatment discontinuation in 1% (n=7) of patients.From baseline to Week 192, the median change in body weight (Q1, Q3) was an increase of 4.9 kg (1.3, 9.9), and weight increased by 3 kg (0.3, 5.8) during the first year of treatment.
Conclusion: After 4 years of follow-up, treatment with Biktarvy demonstrated high efficacy and durable virologic suppression, with no treatment-emergent resistance, a low incidence of adverse events, and low discontinuation rates.
Biktarvy is a once-daily, single-tablet regimen (STR) for the treatment of HIV-1 infection. The drug combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir (BIC) with the proven efficacy and safety of the already marketed Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg, FTC/TAF), a two-drug nucleoside reverse transcriptase inhibitor (NRTI) backbone therapy recommended by HIV clinical treatment guidelines. In Phase 3 clinical trials, Biktarvy achieved very high virologic suppression rates in both treatment-naive patients and virologically suppressed patients switching regimens, with no treatment-emergent resistance observed.
In the United States, Biktarvy was approved for marketing in February 2018. The indications for this drug are: as a complete regimen for the treatment of HIV-1 infection in pediatric patients (weighing ≥25 kg) and adult patients with no history of treatment failure and with no known substitutions associated with resistance to the individual components of Biktarvy. Specifically: (1) antiretroviral treatment-naïve patients; and (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 carries a black box warning regarding the risk of acute exacerbation of hepatitis B following treatment discontinuation.
In 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 with no evidence of current or historical viral resistance to integrase strand transfer inhibitors, emtricitabine, or tenofovir. (Bioon.com)