Table 3.

Clinical trial evaluation of hepatic toxicity and incidence for nucleoside reverse transcriptase inhibitors.

Reference	Drug(s)	No. of Study Patients	Hepatic Evaluation	Overall Incidence of Cases/100 Persons Exposed	Study Design	Patient Population
Soni 2008 [26]	Abacavir	2	Patient 1: ALT > 10× ULN Patient 2: ALT > 10× ULN	-	Case report	Patient 1: Female; HLA B*5701 negative; baseline ALT 21 IU/L Patient 2: Female; HLA B*5701 negative; baseline ALT 10 IU/L
Di Filippo 2014 [27]	Abacavir	1	AST: < 5× ULN ALT: > 10× ULN	-	Case report	Male; HLA B*5701 negative; baseline AST 27 IU/L and ALT 85 IU/L
Pezzani 2016 [28]	Abacavir	1	AST: 5× ULN ALT: > 10× ULN	-	Case report	Female; HLA B*5701 negative; baseline AST/ALT normal
Schiano 1997 [29]	Lamivudine	1	Total bilirubin: > 10× ULN ALT: > 10× ULN	-	Case report	Male; HBV co-infection; cirrhosis
Ormseth 2001 [30]	Lamivudine	1	Total bilirubin: >10× ULN ALT: > 10× ULN	-	Case report	HBV co-infection; baseline ALT 171 IU/L, bilirubin 3.1 mg/dL
Mayer 2020 DISCOVER [31]	Tenofovir		Combined grade 3 and 4 AST grade 3: >5.00 to 10.00× ULN grade 4: >10.00× ULN ALT grade 3: >5.00 to 10.00× ULN grade 4: >10.00× ULN	AST: 2 ALT: 1	Prospective	HIV-uninfected; PrEP

Abbreviations: ALT, alanine transaminase; AST, aspartate aminotransferase; HBV, hepatitis B virus; HCV, hepatitis C virus; HLA*B, major histocompatibility complex, class I, B; PrEP, pre-exposure prophylaxis; ULN, upper limit of normal.