by Jeffrey T. Kirchner, DO, AAHIVS, AAHIVM Chief Medical Officer
May 12, 2020
Mills A et al. 144-WEEK EFFICACY AND SAFETY OF B/F/TAF IN TREATMENT-NAIVE ADULTS ≥50 YRS. CROI, 2020 | Boston, MA Abstract # 477
A substantial number of people are living with HIV and advancing in age, therefore having ART regimens that are effective and safe for older patients is important. Few clinical trials of ART have included persons over the age of 50. This study included data from two phase 3, treatment-naive studies of bictegravir. One study (GS-1489) compared BIC/FTC/TAF to dolutegravir, abacavir, and lamivudine (DTG/ABC/3TC) and the second (GS-1490) compared it to DTG + F/TAF. A pooled analysis measured the proportion of subjects with a viral load of <50 c/mL and also assessed safety data at week 144. There was a total of 1,274 patients in the two trials of whom 196 were > age 50. At 144 weeks, virologic suppression was high for all treatment arms with approximately 99% of all subjects for which there was data, having viral loads < 50 copies/mL by FDA snapshot analysis. Regarding adverse events, the most common in persons > age 50 years were nasopharyngitis, diarrhea, and URIs. Adverse events leading to study drug discontinuation for participants > 50 occurred in only 2% on B/F/TAF, 5% on DTG/ABC/3TC and 7% on DTG + F/TAF. Only 1% of all patients < age 50 stopped treatment due to AEs. Mean changes in hip and spine BMD (only study 1489) were similar in both age groups. There were small increases in fasting lipids with all three drug regimens but these were not clinically significant. Regarding renal function, there were no cases of proximal renal tubulopathy and levels of proteinuria and renal biomarkers were similar between groups and did not differ by age. The authors conclude that through almost three years of treatment, B/F/TAF is very effective, safe, and well-tolerated in adults > 50 years of age.
As the use of bictegravir increases among patients, including those with advanced age, it is important to have this data. I believe there are no concerns regarding the efficacy of BIC/FTC/TAF. However, long-term drug safety, including renal and bone, is important for patients. In addition, the absence of a pharmacokinetic booster makes this combination regimen safer for patients who are taking other medications such as statins, anticonvulsants, and direct-acting anticoagulants.
The author has no conflicts of interest to disclose.
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