Table 2.

Incidence and relative risk of severe hepatotoxicity associated with highly active antiretroviral therapy^*

Antiretroviral drug regimen	n	Cases	Person- time (100 person- months)	Incidence (cases/ persons exposed) (95% CI)	Incidence (cases/100 person-months) (95% CI)	Relative risk (95% CI)
Dual nucleoside analogue	87	5	246	5.7 (1.2–12.9)	2.0 (0.7–4.7)	1.0
Protease inhibitor (all)	112	26	795	12.3 (8.2–17.5)	3.3 (2.1–4.8)	2.2 (0.9–5.4)
Ritonavir (single protease inhibitor)	22	6	96	27.3 (10.7–50.2)	6.3 (2.3–21.6)	4.8 (1.6–14.1)
Ritonavir plus saquinavir	28	9	79	32.1 (15.9–52.4)	11.4 (5.2–21.6)	5.6 (2.1–15.3)
Saquinavir†	17	1	98	5.9 (0.15–28.7)	1.0 (0.7–4.8)	1.0 (0.1–8.2)
Indinavir	117	8	520	6.8 (3.0–13.1)	1.5 (0.7–3.0)	1.2 (0.4–3.5)
Nelfinavir	51	3	153	5.9 (1.2–16.2)	2.0 (0.4–5.7)	1.0 (0.3–4.1)
Total	298	31	1041	10.4 (7.2–14.4)	3.1 (2.1–4.3)	NA

Reprinted with permission from Sulkowski et al. [35].

CI, confidence interval; NA, not applicable; PEG-IFN, pegylated interferon; RBV, ribavirin.

^*Because use of individual drugs was studied, some overlap occurred during the study period; thus, the individual numbers of patients and cases and the person-time for specific protease inhibitor categories do not equal the ‘Total.’

^†Saquinavir hard gelatin capsule formulation without concurrent ritonavir prescription. The case occurring in a patient receiving saquinavir alone (i.e. not in combination with ritonavir) is also counted in the indinavir category because the patient was taking both drugs at the time of the toxicity.