Gilead's Biktarvy® Shows High Efficacy and No Treatment-Emergent Resistance Over Four Years in HIV-1 Patients; Approved in China

March 08, 2021 /BioonBIOON/ -- Gilead Sciences recently at the 2021 Conference on Retroviruses and Opportunistic InfectionsMeeting(CRIO) announced new long-term data from the open-label extension (OLE) phases of two randomized, double-blind, active-controlled Phase III studies (Study 1489 and Study 1490) evaluating Biktarvy® (Chinese brand name: Bictovi®; generic name: bictegravir, emtricitabine, and tenofovir alafenamide tablets; bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a novel three-in-one combination therapy. These two studies were conducted in treatment-naïve adults with HIV-1 infection, comparing Biktarvy with dolutegravir (DTG)-containing regimens. The latest data from both studies confirmed the sustained efficacy and safety of Biktarvy in the treatment of HIV-1 infection, demonstrating high rates of virologic suppression through four years of treatment, with no emergence of treatment-emergent resistance.

In two studies, 1,274 treatment-naïve adult patients were randomized to receive Biktarvy or dolutegravir/abacavir/lamivudine (50/600/300 mg; DTG/ABC/3TC) (Study 1489) or DTG plus emtricitabine/tenofovir alafenamide (50/200/25 mg; F/TAF) (Study 1490). The primary endpoint for both studies was the rate of virologic suppression at Week 48. Previously published data demonstrated that both studies met their primary endpoints of non-inferior efficacy at Week 48. Outcomes were also assessed at Week 144, showing that patients in both groups achieved undetectable viral loads with no emergence of treatment-emergent resistance. After Week 144, patients could receive Biktarvy for up to 96 weeks during an open-label extension (OLE) period. Both studies are currently ongoing.

Data presented at this conference showed that, over 4 years of follow-up, more than 98% of patients who initiated Biktarvy treatment and remained in the studies achieved and maintained undetectable viral load (HIV RNA <50 copies/mL) (Study 1489: n=235/237; Study 1490: n=241/243). During the 48-week open-label extension (OLE) phase, high and durable virologic suppression was observed monthly among patients switched from a dolutegravir (DTG)-based triple therapy to Biktarvy (Study 1489: n=212; Study 1490: n=225). No treatment-emergent resistance to any component of Biktarvy was observed in patients receiving Biktarvy.

At this conference, additional data on Biktarvy were presented, including results from a 144-week analysis of the aforementioned two studies (Study 1489 and Study 1490). The data showed that HIV-infected individuals who initiated treatment with Biktarvy achieved and maintained undetectable viral loads through Week 144, with no treatment-emergent resistance (n=634). In a subgroup analysis based on retrospective sequencing of baseline samples in patients with transmitted drug resistance (TDR, n=248), Biktarvy demonstrated similarly high rates of durable viral suppression at 144 weeks in patients with and without TDR (98% vs. 97%; post-treatment analysis).

The use of Biktarvy in individuals with known resistance to Biktarvy components is investigational; such use has not been approved by the U.S.FDAApproved; its safety and efficacy have not been established.

Diana Brainard, M.D., Senior Vice President of the Therapeutic Area of Virology at Gilead Sciences, stated: “Gilead is committed to developing innovative HIV treatments, such as Biktarvy, to help address unmet needs among people living with HIV, including achieving and maintaining an undetectable viral load over the long term. These data further demonstrate that Biktarvy provides durable viral suppression, robust efficacy, and a high barrier to resistance in both treatment-naïve adults and treatment-experienced adults who are switching from their existing regimens.”

Kimberly Workowski, MD, Professor of Medicine at Emory University, stated, “As a clinician, my goal is to initiate therapy immediately upon diagnosis with a regimen that can achieve and maintain long-term virologic control. The data presented at the Conference on Retroviruses and Opportunistic Infections (CROI) highlight that Biktarvy can achieve sustained virologic suppression for up to four years in a broad range of people living with HIV, and support further research in certain patients with transmissible drug-resistant HIV.”

Biktarvy is a once-daily, single-tablet regimen (STR) for the treatment of HIV-1 infection. This medication combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir (BIC) with the proven efficacy and safety profile of the approved drug Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg, FTC/TAF), which is a dual-nucleoside reverse transcriptase inhibitor (NRTI) backbone therapy recommended by clinical guidelines for HIV treatment. In Phase III clinical studies, the Biktarvy regimen achieved very high rates of virologic suppression in both treatment-naïve adults and virologically suppressed adults who switched to this regimen, with no emergence of treatment-emergent resistance.

In the United States, Biktarvy was approved in February 2018, becoming the third FTC/TAF-based single-tablet regimen (STR) authorized in this market over the past three years. Biktarvy is indicated as a complete regimen for adults with HIV-1 infection who have no evidence of current or prior resistance to emtricitabine or tenofovir, and who are naive to integrase inhibitors. No dosage adjustment of Biktarvy is required in patients with an estimated creatinine clearance (CrCL) ≥30 mL/min. The drug offers convenient dosing, does not require HLA-B*5701 testing, and has no restrictions related to food intake, baseline viral load, or CD4 count. Notably, the prescribing information for Biktarvy includes a boxed warning regarding the risk of acute exacerbation of hepatitis B following discontinuation of treatment.

In China, Biktarvy® was approved in Hong Kong in October 2018 and on the mainland 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 viral resistance to integrase inhibitors, emtricitabine, or tenofovir, either currently or historically.

Currently, Gilead is conducting additional studies to evaluate the efficacy and safety of Biktarvy in adolescents, children, and women living with HIV. Data presented in early March at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, USA, demonstrated that Biktarvy exhibited high efficacy in adults aged 50 years and older, women, children and adolescents, and individuals with resistance to nucleoside reverse transcriptase inhibitors (NRTIs). (Bioon.com)

Original Source: Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults in Four-Year Data Presented at CROI