Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide as maintenance treatment in HIV/HBV-coinfected patients.

BACKGROUND The efficacy and safety of switching from tenofovir disoproxil fumarate (TDF)-based antiretroviral therapy to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) has not been widely investigated in HIV/HBV-coinfected Asian population. METHODS Between February and October 2018, HIV/HBV-coinfected patients who had achieved HIV viral suppression with TDF-containing regimens were switched to E/C/F/TAF. Assessments of plasma HBV and HIV viral load, HBV serology, renal function, lipid profiles, and bone mineral density (BMD) were performed at weeks 24 and 48 after switch. RESULTS A total of 274 HIV/HBV-coinfected participants were enrolled, with 12.8% testing HBeAg-positive and 94.2% having plasma HBV DNA <20 IU/mL at baseline. At weeks 24 and 48, 92.7% and 89.8% achieved plasma HBV DNA <20 IU/mL; 4.7% and 5.1% had HBV DNA ≥20 IU/mL; and 2.6% and 5.1% had no data, respectively. At weeks 24 and 48, 95.6% and 94.2% of participants maintained HIV RNA <50 copies/mL, respectively. Compared with baseline, the median urine β2-microglobulin-to-creatinine ratio at week 48 decreased significantly from 241 to 134 μg/g (p<0.001). The mean BMD of the spine and hip improved at week 48 (+1.77% and +1.33%, respectively). Significantly higher lipid profiles were observed after switch to E/C/F/TAF. Thirteen (4.7%) patients withdrew from the study before week 48, with 7 (2.6%) due to adverse effects. CONCLUSIONS Switch to E/C/F/TAF maintained HBV and HIV viral suppression and resulted in improvement of proteinuria and BMD of the spine and hip, but increased lipid levels in HIV/HBV-coinfected patients at week 48.