A study published in the Journal of Antimicrobial Chemotherapy sought to generate real-life clinical data on the use of bictegravir/emitricitabine/tenofovir alafenamide (BIC/FTC/TAF) for the treatment of people living with human immunodeficiency virus (PLWH). Juan Ambrosioni, MD, PhD, and colleagues from the Infectious Disease Service, HIV unit of the Hospital Clínic-IDIBAPS at the University of Barcelona in Barcelona, Spain, demonstrated that BIC/FTC/TAF had high rates of viral suppression, as well as good tolerability and safety profiles, and persistent responses. Dr. Ambrosioni further noted that the effective virological suppression was also observed “in PLWH carrying lamivudine/emtricitabine resistance substitutions.”
The trial retrospectively analyzed 1,584 PLWH, of which 213 were treatment-naïve (TN) and 1,371 were treatment-exposed (TE). The researchers assessed tolerability and safety, and calculated effectiveness for on treatment (OT), modified intention-to-treat (mITT) and intention-to-treat (ITT) enrolled patients who completed six months of follow-up.
The full cohort had a median follow-up of 16 months (interquartile range [IQR] = 7–21), with 81% and 53% of participants reaching six and 12 months of follow-up, respectively. For OT patients who were TN, the rates for HIV-RNA <50 copies/mL were 77% at month six and 92% at month 12. The rates for OT TE patients were 94% at month six and 93% at month 12. For mITT patients, the month six rates were 70% and 89%, and the month 12 rates were 77% and 85% for the TN and TE groups, respectively. For ITT PLWH, the TN group rates were 62% at month six and 63% at month 12, while ITT TE PLWH had rates of 83% and 78% at month six and month 12, respectively.
Among OT PLWH carrying an M184V/I substitution, the six month rate of RNA <50 copies/mL was 89.5%. Lastly, the median CD4 cell count had increased from 329 to 511/μL in TN PLWH, and from 630 to 683/μL in TE PLWH after six months.
Given that seven cases were considered virological failures (0.6% of OT cohort at month six) and no emergent resistance substitutions were observed in their real-life data, the authors ultimately assessed that BIC/FTC/TAF was an effective treatment option for PLWH.
Source: Journal of Antimicrobial Chemotherapy