– New 5-Year Clinical and Real-World Data Reinforce Biktarvy® as a Long-Term Treatment Option for a Diverse Range of People with HIV, Including Those with Comorbidities –
– Investigational, Once-Daily, Once-Weekly and Twice-Yearly Dosing Frequencies Across Administration Methods Aim to Expand Options, Advance Public Health and Help Address Unmet Needs in HIV Treatment –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data from its innovative HIV treatment portfolio and research pipeline, including a broad range of investigational and marketed agents with varied dosing frequencies and administration methods. The findings presented at the 25th International AIDS Conference (AIDS 2024) reflect a portfolio and future-looking pipeline focused on person-centered drug development strategies to help address unmet needs in HIV treatment.
"People are at the center of all we do in HIV treatment research at Gilead. We strive to support people with HIV throughout their lifetimes, with research to maximize the impact of current treatment options and diligent work to develop treatment options for the future,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head. “Durable viral suppression is the primary goal of HIV care and treatment, resulting in longer, healthier lives for people with HIV and, when undetectable, eliminating the risk of transmitting the virus to partners. Long-term success includes rigorous innovation so that each person can be on the right treatment for them that will support long-term treatment outcomes.”
Five-Year Data Shows Biktarvy Maintains High Rates of Virologic Suppression in Hispanic/Latine People with HIV
New research presented at AIDS 2024 demonstrated the durability and long-term safety profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in Hispanic/Latine people with HIV, who often experience disparities in health outcomes and are often under-represented in HIV clinical trials. Specifically, results of the subgroup analysis showed that at five years, Biktarvy treatment was generally well tolerated and maintained high virologic suppression. Based on a Missing=Excluded (M=E) analysis, 100% of the Hispanic/Latine participants and 98.1% of the non-Hispanic/Latine participants maintaining undetectable status and a viral load of less than 50 copies/mL at Week 240. No treatment-emergent resistance was detected. This analysis evaluating Biktarvy includes a pooled analysis of two Phase 3 randomized studies (Study 1489 and Study 1490) in Hispanic/Latine people with HIV who were initiating treatment with Biktarvy in the 144-week randomization phase and in the 96-week open-label extension phase.
“HIV affects some communities more significantly and deeply than others, and the Hispanic/Latine community specifically needs the results of long-term studies that examine differences in outcomes and treatment nuances," said Santiago Moreno Guillen, MD, Head of the Infectious Diseases Service at the Ramón y Cajal Hospital in Madrid. "These long-term findings will help us determine the best treatment approach and can make a very big difference in the lives of our community. The robust efficacy shown in Hispanic/Latine participants at five years provides remarkable long-term insight and reinforces the role of Biktarvy as an effective treatment option for Hispanic/Latine people living HIV."
Biktarvy was generally well tolerated in both groups, with similar metabolic and safety outcomes and few TEAEs leading to treatment discontinuation. The most common study drug-related TEAEs in Hispanic/Latine or non-Hispanic/Latine participants, respectively, were diarrhea (2%, 6%), headache (5%, 5%), and nausea (3%, 5%).
Switch Data From Real-World BICSTaR Study Shows Biktarvy Maintains High Levels of Virologic Suppression in Older Adults With Comorbidities
Additional new long-term data from the Bictegravir Single Tablet Regimen (BICSTaR) study evaluated the effectiveness and safety of Biktarvy in people aged 50 years and older with HIV who switched to the single-tablet regimen and currently have or have had at least one additional medical condition. Outcomes at two years included viral suppression rates, treatment-emergent resistance, drug-drug interactions and patient satisfaction (survey conducted 12 months after switching).
BICSTaR (NCT03580668) is an ongoing, multinational, observational single-arm, non-comparative real-world cohort study, which aims to evaluate the effectiveness, safety, tolerability, and patient-reported outcomes of treatment with Biktarvy in treatment‐naïve and treatment‐experienced people with HIV. Among the people with HIV enrolled in the BICSTaR study, there is a high baseline prevalence of comorbidities.
Results showed high rates of effectiveness two years after switching to Biktarvy, with 96% (315/328) of individuals maintaining an undetectable viral load of less than 50 copies/mL based on a Missing=Excluded (M=E) analysis. Viral suppression rates at 24 months were similar regardless of age, sex and race at the time of the switch, ranging from 93-100% across subgroups. Patient-reported treatment satisfaction based on the HIVSTQc score increased through one year. No treatment-emergent resistance to Biktarvy was observed throughout the 24 months after switching.
The BICSTaR population included 401 people with a median age of 56 years, with 86% male, 81% White and 18% aged 65 years or older. Most common baseline comorbidities were cardiovascular (48%), metabolism and nutrition disorders (48%), infections (34%), and psychiatric disorders (34%), and 22% were taking five or more comedications. Switching to Biktarvy was generally well tolerated. Treatment-related adverse events (TRAEs) occurred in 13% (54/401) of patients, with serious TRAEs occurring in 0.2% (1/401). Discontinuation due to TRAEs occurred in 7% (27/401) of patients. Those who switched to Biktarvy remained clinically stable, with no significant worsening in lipid, kidney or liver measures.
The data presented at AIDS 2024 complement those observed in multiple Phase 3 clinical trials, which demonstrated the sustained efficacy, safety profile, and high barrier to resistance of Biktarvy.
Once-Daily Oral Combination of Bictegravir and Lenacapavir Demonstrates Sustained Viral Suppression
ARTISTRY-1 (NCT05502341) is an ongoing, open-label, multicenter Phase 2/3 study being conducted to compare the investigational once-daily combination of bictegravir, an integrase strand transfer inhibitor, and lenacapavir, a first-in-class capsid inhibitor, versus current therapy in people with HIV who require a complex treatment regimen to maintain virologic suppression, primarily due to a history of resistance. It is estimated that up to 8% of people with HIV take a complex treatment regimen, defined as two or more pills each day, although single-tablet regimens have become standard of care for HIV treatment due to their simplified dosing and potential benefits for adherence.
In ARTISTRY-1, 128 participants on a stable baseline regimen for six or more months prior to screening were randomly allocated in a 2:2:1 ratio to receive once-daily oral bictegravir 75 mg + lenacapavir 25 mg, bictegravir 75 mg + lenacapavir 50 mg or continue their current stable baseline regimen (n=25). The 24-week primary efficacy and safety outcomes for bictegravir + lenacapavir in people with HIV who are virologically suppressed on a complex regimen have been previously presented and demonstrated that all three treatment groups had robust virologic suppression at six months, with consistently low viral loads throughout the study.
Week 48 outcomes presented at AIDS 2024 show that 90% of participants (n=52) treated with once-daily oral bictegravir 75 mg + lenacapavir 50 mg and 92% of participants (n=51) treated with once-daily oral bictegravir 75mg + lenacapavir 25 mg were virologically suppressed (HIV viral load