Background: Highly active antiretroviral therapy (HAART) has been
associated with liver toxicity. The role of monitoring for liver
toxicity has not been well studied in resource-limited settings (RLS).
Objectives: To determine the background prevalence and incidence of
liver injury and describe the associated signs and symptoms of acute
hepatitis after initiating HAART; and to determine the role of liver
enzyme tests in monitoring hepatotoxicity. Methods: In this prospective
study, in Mulago Hospital AIDS Clinics, we consecutively enrolled adult
patients initiated on one of three first line HAART regimens [Stavudine
(d4T)-Lamivudine (3TC) and nevirapine (NVP); Zidovudine (AZT)-3TC and
Efavirenz (EFV) or d4T-3TC-EFV]. We monitored ALT (alanine
aminotransferase) and clinical evidence of acute hepatitis at baseline,
2nd, 6th, 10th and 14th week of therapy. Results: Two hundred and forty
HIV-positive HAART- naïve patients were enrolled in the study. The
baseline prevalence of transaminitis was 1.7% with an incidence of 4.2%
at 14 weeks. Grade 3-4 hepatotoxicity was documented in 1.3%. Jaundice
was seen in grade 2-4 ALT elevations. Being on concurrent HAART and
antituberculous drugs was associated with grade 2-4 toxicity compared
to those who were only on HAART [OR; 16.0 (95% CI; 2.4-104.2)].
Conclusions: Incidence of severe hepatotoxicity within three months of
first-line antiretroviral therapy was low, suggesting that routine
measurement of transaminases may not be necessary in all patients
initiating HAART in RLS. Routine measurement may be important in
following patients on HAART and concurrent TB treatment as well as
those with jaundice to avoid missing hepatotoxicity