Nicola Squillace 1 , Elena Ricci 2 , Barbara Menzaghi 3 , Giuseppe Vittorio De Socio 4 , Simone Passerini 5 , Canio Martinelli 6 , Maria Sabrina Mameli 7 , Paolo Maggi 8 , Katia Falasca 9 , Laura Cordier 5 , Benedetto Maurizio Celesia 10 , Elena Salomoni 11 , Antonio Di Biagio 12 , Giovanni Francesco Pellicanò 13 , Paolo Bonfanti 1 , On behalf of the CISAI Study Group
15 December 2020
We aimed to investigate the effect of switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) on the hepatic safety and metabolic profile.
Consecutive HIV patients, enrolled in the Surveillance Cohort Long-term Toxicity Antiretrovirals/Antivirals (SCOLTA) project, switching from TDF to TAF were included. Changes from baseline (T0) to 6-month follow-up (T1) were evaluated using paired t-test and signed rank test.
A total of 190 patients switched from TDF to TAF and had one 6-month follow-up visit. They were 80% male, 74.2% at CDC stage A–B, 93.7% with undetectable HIV-viral load. Mean age was 46.7±10.7 years, body mass index was 25.0±3.9 kg/m 2, median CD4 cell count was 634 cell/µL (interquartile range [IQR]=439–900), aspartate aminotransferase (AST) was 23 (IQR=19–30) IU/L, and alanine aminotransferase (ALT) was 24 (IQR=17–34) IU/L. At T1, both AST (median=−1, IQR=−5–2 IU/L, P=0.004) and ALT (median=−2, IQR=−7–3 IU/L, P=0.0004) showed a significant decrease. Among 28 patients with ALT >40 at baseline, reduction was significant both clinically (−17, IQR=−32–−1) and statistically ( P=0.0003). Total cholesterol levels (TC) increased (+13.4±3.8 mg/dL, P=0.0006), as well as HDL-cholesterol (HDL-C) (+3.8±1.2 mg/dL, P=0.02), LDL Cholesterol (LDL-C) (+7.6±3.4, P=0.03) and glucose (+4.0±1.8 mg/dL, P=0.02). D:A:D: and Framingham risk score did not change at 6 months after switch.