Switching from EFV/FTC/TDF to BIC/FTC/TAF maintains virologic suppression in people living with HIV

Switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) to the new bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) regimen maintained high rates of virological suppression in adults who are living with HIV*, according to a study presented at AIDS 2020.

The researchers conducted an open-label, single-centre, single-arm, prospective study involving 91 virologically suppressed adults with HIV-1 infection (median age 55 years, 98.0 percent male) who were switched from EFV/FTC/TDF to BIC/FTC/TAF. The participants were screened for HIV-RNA, CD4 cell count, CD4%, serum creatinine, and weight changes at every study visit until week 48. HIV Symptom Index and Pittsburgh Sleep Quality Index (PSQI) were used to assess patient-reported outcomes. [AIDS 2020, abstract PEB0359]

Of the 87 participants who completed the study, 89.7 percent had confirmed virological suppression (defined as HIV-1 RNA <50 copies/mL) at week 48. However, 6.9 percent did not meet the criteria for virological suppression (HIV-1 RNA >50 copies/mL) and 3.4 percent had no virological data.

Participants switched to BIC/FTC/TAF also had significantly improved sleep quality, as shown by a decreased PSQI score from baseline to week 48 (mean score change from 6.84 to 4.95; p=0.012). This was the most impressive change in patient-reported outcomes, said lead author Dr Erik Lowman from Midland Research Group in Oakland Park, Florida, US.

In addition, all other bothersome symptoms, such as memory issues, muscle aches, anxiety, and depression, were remarkably reduced at 48 weeks, Lowman noted.

Switching to the BIC/FTC/TAF regimen also led to significantly reduced total cholesterol (TC), LDL cholesterol, and TC:HDL** cholesterol levels (mean change from baseline, -10.9 mg/dL; p<0.01, -7.63 mg/dL; p<0.01, and -0.26 mg/dL; p=0.01, respectively).

Of note, there was only a slight increase in mean body weight from baseline to week 48 (from 87.0 to 88.1 kg; p=0.292). Four and three participants experienced weight loss and gain of ≥10 percent, respectively.

The researchers found no significant changes in CD4 cell count, CD4%, weight, serum creatinine, or triglyceride or HDL levels.

“With the evolution of potent antiretroviral therapy, virologically suppressed people living with HIV  are often switched to regimens considered simpler and safer, with improved tolerability and potentially avoiding long-term toxicities without compromising efficacy,” said Lowman.

“Switching patients from EFV/FTC/TDF to BIC/FTC/TAF is safe, well-tolerated, and maintains virologic suppression,” Lowman said. “[P]erhaps the greatest benefit is the rapid and significant improvement in sleep quality and a marked reduction in reports of bothersome symptoms,” he said.

“[However,] extrapolation of our results may be limited by the predominantly white male population,” he added.

*HIV: Human immunodeficiency virus

**LDL: Low-density lipoprotein; HDL: High-density lipoprotein