New data presented at IDWeek 2024 highlights the sustained efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), marketed as Biktarvy, in Black adults living with HIV (PWH) over a five-year period. The findings, presented by Dr. Anson K. Wurapa, an infectious disease specialist, suggest that Biktarvy maintains high rates of virologic suppression in this population, even with slightly lower adherence compared to non-Black individuals. This research underscores the importance of inclusive clinical trials in addressing healthcare disparities and improving treatment outcomes for Black communities affected by HIV.
Long-Term Efficacy and Safety
The analysis pooled data from two Phase 3 randomized, double-blind studies (1489 and 1490), comparing B/F/TAF with other regimens in adult PWH. It included outcomes from Black and non-Black participants during a 144-week randomization phase and a 96-week open-label extension, examining demographics, virologic outcomes, adherence, TEAEs, and changes in CD4 counts and metabolic parameters. By the fifth year of the study, 97.2% of Black PWH and 99.3% of non-Black PWH had HIV-1 RNA levels below 50 copies/mL, demonstrating the drug's potent antiviral activity.
Adherence and Adverse Events
While Biktarvy demonstrated high efficacy in both Black and non-Black participants, adherence rates differed slightly between the two groups. Approximately 11.2% of Black PWH had low adherence (less than 85%), compared to 5% of non-Black PWH. Dr. Wurapa attributed this difference to social and economic factors, including access to care, mental health issues, and substance abuse, which can impact medication adherence.
Despite the slightly lower adherence rates, Biktarvy was well-tolerated among Black participants. Only 20.4% of Black PWH experienced treatment-emergent adverse events (TEAEs) related to the study drug, compared to 31.8% of non-Black PWH. Baseline data showed that rates of hypertension and diabetes were similar in both groups, and treatment with Biktarvy did not increase the risk of developing these conditions in Black patients compared to non-Black patients.
Implications for Clinical Practice
These findings have important implications for clinical practice, particularly in the treatment of HIV in Black communities. Black individuals are disproportionately affected by HIV and may face greater lifetime risks of comorbidities compared to non-Black PWH. Historically, they have been underrepresented in clinical studies, which can impact the effectiveness of treatment strategies. Dr. Wurapa emphasized the importance of encouraging adherence and providing culturally competent care to improve treatment outcomes in this population.
"From the patient standpoint, I think it improves their confidence and trust in what they're being asked to take, knowing that it has actually been looked at in their specific demographic," Dr. Wurapa stated. He also highlighted the clinician's perspective, noting that having data specific to Black patients helps clinicians feel more comfortable with medication choices and allows them to have more informed discussions with their patients.
This study reinforces the importance of inclusive research in developing effective treatment protocols and improving health outcomes in Black communities, paving the way for future studies to address healthcare disparities and enhance patient care.
