Gilead Touts Long-Term Efficacy And Safety Data For HIV Drug

Gilead has revealed real-world results from the two-year BICSTaR study on Biktarvy, touting the drug as a well-tolerated and effective treatment for HIV patients regardless of prior treatment or comorbidity status. 

Biktarvy is a complete standalone regime for HIV that combines three drugs: the integrase strand transfer inhibitor (INSTI) bictegravir, emtricitabine 200 mg, and tenofovir alafenamide 25 mg. It is indicated for HIV treatment in adult and pediatric patients who have no antiretroviral treatment history or virally-suppressed patients who are switching to another therapy. 

Results from two other trials, Study 1489 and Study 1490, highlighted Biktarvy’s efficacy and safety for patients switching to the treatment from a dolutegravir-based regime. 

Gilead presented the latest data at the 30th International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2022). 

Related Article: A Cure for HIV Could Be Here Sooner Than You Think – Future of Health

High Viral Suppression And Low Discontinuation Rate 

The BICSTaR study follows up with patients across nine countries and considers age, race, sex, adherence, and late diagnosis. Many patients enrolled in the study also presented with comorbidities. In the study, 24 months of Biktarvy led to viral suppression in 97% of treatment-naive patients and 95% in the treatment-experienced, meaning the drug reduced the viral load to a point where patients no longer transmit HIV. 

Treatment discontinuations are low (14%), Gilead said, while 7% discontinued Biktarvy due to drug-related side effects such as weight change and depression. 

“These latest data demonstrate how innovation and improvement in HIV treatment options can help people living with HIV and their clinicians identify an HIV treatment regimen that supports their treatment over the long term,” said Benoit Trottier, MD, Physician, and Director of Research at Clinique de Médecine Urbaine du Quartier Latin, Montreal, Canada.

“Factors such as aging and comorbidities are vital components of long-term health discussions. The BICSTaR study reinforces the real-world effectiveness of Biktarvy across populations with a range of comorbidities, and the findings are consistent with evidence from randomized clinical trials of Biktarvy treatment,” he said.

A Safe And Efficacious Switch 

Meanwhile, data from Study 1489 and Study 1490 showed Biktarvy’s safety and efficacy in patients switching to the treatment from dolutegravir + 2 nucleoside reverse transcriptase inhibitors (NRTIs). Furthermore, patients did not develop resistance to Biktarvy following the switch. 

At week 240, more than 99% of patients in both studies achieved viral suppression. Over 96% maintained viral suppression following the switch to Biktarvy. The drug was well-tolerated, with 0.4% of patients discontinuing treatment due to drug-related side effects, which included diarrhea (0.6%) and weight change (0.6%).

The five-year data in BICSTaR, Study 1489, and Study 1490 has led to an FDA-approved label change for Biktarvy to include the efficacy data from the three studies. 

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Joy Lin

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