Patients Maintain Disease Suppression After One Year on Gilead HIV Drug

 

Gilead Sciences has one of the most robust HIV pipelines in the world. New real-world data from the ongoing BICSTaR study demonstrated the ongoing benefits of treatment with HIV drug Biktarvy and quality-of-life issues faced by patients who have been treated with the drug for one year.

Data from the study presented at the European AIDS Conference demonstrated that treatment with Biktarvy allowed patients to maintain control of their disease. Data showed that 97% of treatment-naïve adults and 96% of treatment-experienced adults achieved and maintained virologic suppression after one year of treatment.

Participants included adults over the age of 50, cisgender women, and late presenters. Gilead noted that both treatment-naïve and treatment-experienced participants had a 91% persistence with Biktarvy across both groups. Biktarvy was generally well-tolerated, and no resistance to the components of Biktarvy emerged.

Gilead said the findings reinforce the real-world effectiveness of Biktarvy across populations and are consistent with evidence seen in randomized clinical trials.

Gilead Sciences has three of the top four best-selling HIV drugs on the market. In 2018, Gilead initially won the approval of Biktarvy, a triple combination treatment of bictegravir and emtricitabine/tenofovir alafenamide for the treatment of HIV-1. Earlier this month, the FDA greenlit Biktarvy for pediatric HIV patients virologically suppressed or new to antiretroviral therapy.

The BICSTaR study also examined additional real-world outcomes in the study population, including patients with a high baseline prevalence of comorbidities. Patients were asked to complete questionnaires at the beginning of the study to gain a baseline reading and at the 12-month mark. The questionnaires assessed patient-reported outcomes covering a range of measures, the company noted. Gilead said the BICSTaR study underlines the importance of maintaining patient-reported outcomes to better understand the impact treatment has on mental health and health-related quality of life and treatment satisfaction.

Fernando Bognar, M.D., vice president of Medical Affairs in HIV at Gilead Sciences, said that despite significant advances in antiretroviral therapy, many HIV patients continue to experience additional symptoms that can require “person-centered care.” Bognar said the patient-reported outcomes in the BICSTaR study offer a first-hand assessment of the impact of HIV treatment and care on the quality of life of HIV patients.

“As physicians and people living with HIV look to understand what long-term treatment means to them individually, these data presented at EACS also reinforce that Biktarvy can meet the specific treatment needs of diverse groups of people, including men and women aging with HIV and those with existing comorbid conditions,” Bognar said in a statement.

Additional data presented at EACS 2021 include a Phase III trial that demonstrated the durable efficacy of Biktarvy. In the study, 99% of people living with HIV who switched to Biktarvy from a boosted protease inhibitor-based regimen maintained and achieved long-term viral suppression through a median of 101 weeks. That included 98% of participants with pre-existing resistance and 98% of participants with viral blips.

HIV has taken the lives of an estimated 35 million people over the last 40 years since it first emerged in the 1980s. Currently, about 1.1 million Americans are living with HIV infection. It is estimated that 38,000 Americans are diagnosed with the infection each year, down significantly from peak infections.