2.2. Study Design and Population

It was a prospective cohort hospital-based study. The study population was naïve HIV/AIDS, naïve TB, and HIV/TB-coinfected patients, who accepted to be put on treatment. We enrolled 183 participants consecutively, from which the 125 involved in the study were selected based on the inclusion and exclusion criteria. The expected sample size was 173 using 13.6% prevalence of abnormal liver enzymes among HIV-infected patients on ATD taken from a similar setting [16], 95% confidence interval, and the margin of error 0.05.

We had three groups from the study participants: HIV/AIDS, TB, and TB/HIV.

Inclusion criteria: patients aged ≥15 years, newly diagnosed HIV/AIDS patients who accepted to be initiated on HAART, and patients newly diagnosed with TB with positive sputum smear.

Exclusion criteria: all those who had abnormal levels of the renal function test and liver function test (greater than two times the ULN) and hepatitis before the start of treatment, pregnant and lactating women, patients receiving any other hepatotoxic drugs parallel with HAART and antituberculosis drugs (ATD), and patients who are not willing to give useful and truthful information.

The participants were on the first-line regimen of HAART (TDF, 3TC, and EFZ) or ATD (INH, PZA, RIF, and EMB), and also, all the participants on HAART were on cotrimoxazole and TB prophylaxis (INH).