The Effect of Switching from Tenofovir Disoproxil Fumarate (TDF) to Tenofovir Alafenamide (TAF) on Liver Enzymes, Glucose, and Lipid Profile

Abstract

Objective

We aimed to investigate the effect of switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) on the hepatic safety and metabolic profile.

Methods

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.

Results

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/m², 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.

Conclusion

A significant reduction of liver enzymes was observed after switching from TDF to TAF, especially in subjects with initial level of ALT >40 IU/L. Glucose, TC, HDL-C, and LDL-C increased, with no effect on cardiovascular risk scores.

Keywords:

• HIV
• TDF
• TAF
• liver enzymes

Acknowledgments

We thank all the members of Coordinamento Italiano Studio Allergie e Infezione da HIV (CISAI).

Coordinators: Paolo Bonfanti (Monza), Antonio Di Biagio (Genova).

Data Management: Elena Ricci (Monza).

Participating centers: G. Chichino, C Bolla, A. Parisini, E. Sarchi (Alessandria); A. Saracino, D. Bavaro, G. Angarano (Bari); L. Calza (Bologna); B. Menzaghi, M. Farinazzo (Busto Arsizio); G. Angioni (Cagliari); P. Maggi (Caserta); M. Gussio, B. M. Celesia (Catania); K. Falasca (Chieti); A. Mastroianni, G. Guadagnino (Cosenza); F. Vichi, E. Salomoni (Firenze); C. Martinelli (Firenze); S. Ferrara (Foggia); A. Di Biagio, L. Taramasso, M. Berruti, M. Bassetti (Genova); C. Molteni, S. Piconi (Lecco); G. F. Pellicanò, G Nunnari (Messina); L. Valsecchi, L. Cordier, S. Parisini, G. Rizzardini (Milano); S. Rusconi, F. Conti (Milano); A. Bandera, A. Gori (Milano); D. Motta, M. Puoti (Milano); N. Squillace, P. Bonfanti (Monza); S. Martini (Napoli); O. Bargiacchi, P. L. Garavelli (Novara); A. Cascio, M. Trizzino (Palermo); R. Gulminetti (Pavia); G. V. De Socio, M. Nofri, D. Francisci (Perugia); D. Cibelli, G. Parruti (Pescara); C. Dentone, G. Cenderello (Sanremo); G. Madeddu, M. S. Mameli (Sassari); G. Orofino, M. Guastavigna (Torino).

The abstract of this paper was presented at “HIV Drug Therapy” October 28–31, 2018, Glasgow, Scotland, UK as an abstract presentation with preliminary findings. The poster’s abstract was published in “Poster Abstracts” in the conference’s website (http://hivglasgow.org/wpcontent/uploads/2018/11/P218.pdf).

Disclosure

Nicola Squillace reports personal fees from ViiV Healthcare and grants from Gilead science, outside the submitted work. Benedetto Maurizio Celesia reports personal fees and non-financial support from MSD, Janssen cilag grants, personal fees, non-financial support, consultancy from Gilead sciences, grants, personal fees, non-financial support, consultancy from ViiV healthcare, outside the submitted work. Paolo Bonfanti reports personal fees from ViiV, Gilead, Jannsen, and Merck, outside the submitted work. The authors report no other potential conflicts of interest for this work.