B/F/TAF keeps HIV RNA levels suppressed at 24 months

Implementing the bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) treatment regimen in routine clinical care can effectively suppress HIV in people living with HIV over 24 months of follow-up, reports a study presented at HIV Glasgow 2022.

In a cohort of 838 patients, 135 (median age 39 years, 87 percent men) were treatment-naïve, while the remaining 703 (median age 49 years, 86 percent men) had undergone previous regimens. The current study drew from BICSTaR, a large, ongoing, prospective observational study with nearly 2,400 enrolled patients. Data for the present analysis were from study participants with available 24-month readings.

B/F/TAF was given as a single-tablet regimen once daily. At 24 months, patients were assessed for HIV-1 RNA levels and treatment persistence. Among treatment-naïve patients, 1 percent had HIV-1 RNA levels <50 c/mL at baseline, which grew to 97 percent at 24 months when excluding those with missing data from the analysis. [HIV Glasgow 2022, abstract P067]

When considering missing data as treatment failure, 89 percent of treatment-naïve patients achieved low levels of HIV-1 RNA at 24 months.

Among treatment-experienced patients, the proportion with HIV-1 RNA <50 c/mL increased from 92 percent at baseline to 95 percent at 24 months. When considering discontinuations as treatment failures, this proportion dropped slightly to 81 percent.

“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, lead study author and director of research at Clinique de Médecine Urbaine du Quartier Latin, Montreal, Canada.

In terms of safety, 128 patients (15 percent) developed drug-related adverse events, two of whom (<1 percent) had serious episodes. Sixty-two (7 percent) patients discontinued B/F/TAF due to toxicities.

The researchers also documented no negative impact of the treatment regimen on weight. Median body weight increased from 69 to 75 kg in treatment-naïve patients, while treatment-experienced counterparts gained a median of 1 kg over 24 months, growing from 76 to 77 kg.

The researchers then assessed whether differences in background factors affected optimal treatment impacts. They found that among treatment-naïve patients, 96 percent of those who received late diagnosis (<350 cells/µL) reached HIV-1 RNA <50 c/mL at 24 months, as opposed to 98 percent of patients diagnosed early.

Among treatment-experienced patients, men also saw slightly lower rates of the principal efficacy endpoint than women (95 percent vs 97 percent), as did those who were younger than 50 years of age (95 percent vs 96 percent). Rates of HIV-1 RNA <50 c/mL were also lower among patients with regimen adherence <95 percent vs ≥95 percent (93 percent vs 96 percent).

While none of these subgroup differences were statistically significant, Trottier noted that “factors such as ageing and comorbidities are vital components of long-term health discussions.”

“The BICSTaR study reinforces the real-world effectiveness of B/F/TAF across populations with a range of comorbidities and the findings are consistent with evidence from randomized clinical trials of B/F/TAF treatment,” he added.