Gilead Presents New Biktarvy Data at CROI 2020, Including Race-Specific Treatment Responses in Black and African American Patients

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The 2020 Conference on Retroviruses and Opportunistic Infections (CROI) is being held in Boston, USA. At this conference, Gilead Sciences announced the latest clinical data for its triple-combination new drug, Biktarvy, including data from the Phase III BRAAVE 2020 study conducted among Black and African American people living with HIV, as well as three-year pooled analysis data from two Phase III studies evaluating first-line treatment in individuals aged 50 years and older living with HIV.

Biktarvy is a once-daily, single-tablet regimen that combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir (BIC) with the proven efficacy and safety of the marketed drug Descovy (emtricitabine and tenofovir alafenamide tablets, FTC/TAF), which is a dual-nucleoside reverse transcriptase inhibitor (NRTI) backbone therapy recommended by HIV clinical treatment guidelines.

Biktarvy was approved for marketing in February 2018 and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg, including: (1) first-line therapy for treatment-naïve individuals; and (2) second-line therapy to replace the current antiretroviral regimen in virologically suppressed individuals who are on a stable antiretroviral regimen, have no history of treatment failure, and have no known resistance to any component of Biktarvy.

In China, Biktarvy (Biktarvy®) was approved in August 2019 as a complete regimen for the treatment of HIV-1 infection in adults, with no current or historical evidence of viral resistance to integrase inhibitors, emtricitabine, or tenofovir.

The following are the key summary data presented at this conference:

—Efficacy and Safety of Biktarvy in Black/African American Adults with HIV-1: In the BRAAVE 2020 study, 495 Black or African American adults with HIV-1 who had achieved virologic suppression on a baseline regimen consisting of two NNRTIs and a third agent were randomized in a 2:1 ratio to either switch to open-label, once-daily Biktarvy or remain on their baseline regimen. Patients with a history of prior treatment failure and pre-existing resistance to NNRTIs, PIs, and/or NRTIs were eligible for enrollment. Individuals with tenofovir resistance, primary INSTI resistance, or a history of treatment failure on an INSTI-based regimen were excluded. Among the evaluable patients, 32% were cisgender women and 2% were transgender women. The primary endpoint was non-inferior virologic response at Week 24 of treatment. The secondary endpoint was the change in CD4 count from baseline.

The results showed that patients switching to Biktarvy from various regimens, including those with pre-existing NRTI resistance, demonstrated non-inferior antiviral efficacy. At Week 24 of treatment, 96.3% of patients receiving Biktarvy maintained virologic suppression, compared to 94.5% of patients who remained on their baseline regimen; no treatment-emergent resistance was detected. The most common adverse events in the study were headache, diarrhea, and insomnia. Most treatment-related adverse events were Grade 1. The incidence of adverse events leading to discontinuation of the study drug was 1.8% among patients receiving Biktarvy and 0% among those maintaining their baseline regimen.

Debbie P. Hagins, Principal Investigator of the BRAAVE 2020 study, stated, “As an African American and a frontline clinician, I am acutely aware of the race-specific complications affecting Black people living with HIV in the United States. Furthermore, there is currently limited understanding of how race influences the efficacy and side effects of HIV medications. BRAAVE 2020 is a landmark study in HIV treatment that investigated race-specific treatment responses among Black and African American populations, who bear the highest burden of HIV infection in the United States. These findings provide further evidence supporting Biktarvy as a highly effective and well-tolerated treatment regimen for Black Americans living with HIV, and they support the need for further research in individuals with pre-existing drug resistance.”

—Long-term Efficacy and Safety of Biktarvy as First-line Therapy in Treatment-naïve Adults Aged ≥50 Years with HIV-1 Infection: Two Randomized, Double-blind Phase III Studies (1489 and 1490)A total of 1,274 treatment-naïve adult patients with HIV-1 infection were randomized to evaluate the efficacy and safety of Biktarvy. Study 1489 compared Biktarvy with the DTG/ABC/3TC regimen, while Study 1490 compared Biktarvy with the DTG + F/TAF regimen. A pooled analysis of these two studies assessed efficacy (defined as maintained virologic suppression: HIV-1 RNA <50 copies/mL) and adverse events over 144 weeks of treatment in participants aged ≥50 years and those aged <50 years at study entry. Across both studies, 196 patients were aged ≥50 years (96 in the Biktarvy group, 41 in the DTG/ABC/3TC group, and 59 in the DTG + F/TAF group); 17% were female, 27% were Black, and 15% were Hispanic/Latino.

Results showed that over 144 weeks of treatment, Biktarvy was highly effective and well tolerated in adults aged ≥50 years, with no clinically significant differences from baseline in bone mineral density or renal safety, fasting lipid profiles, or weight gain. Across all treatment groups, the most common adverse events in patients aged ≥50 years were nasopharyngitis, diarrhea, and upper respiratory tract infections; most treatment-related adverse events were Grade 1. The incidence of study drug discontinuation due to adverse events in patients aged ≥50 years was 2% in the Biktarvy group, 5% in the DTG/ABC/3TC group, and 7% in the DTG + F/TAF group.

In Study 1489, the mean percentage changes in hip and spine bone mineral density, proteinuria, and renal biomarkers were similar between the Biktarvy group and the DTG/ABC/3TC group. Fasting lipid levels showed minimal changes from baseline across all treatment groups. At Week 144, the median weight increased from baseline, with no significant differences observed among the groups. The study is ongoing; after Week 144, all patients will have the option to receive 96 weeks of Biktarvy treatment in an open-label extension phase.

Diana Brainard, M.D., Senior Vice President of HIV and Emerging Viruses at Gilead Sciences, stated, “These data confirm that once-daily Biktarvy is an effective and well-tolerated first-line option for patients switching their treatment regimen. These results highlight Biktarvy’s ability to meet the specific treatment needs of diverse populations of people living with HIV, including older men and women.”

Reference Source: New Data on Gilead’s Biktarvy® Presented at CROI 2020, Including Data in Black Americans and Older Adults