Background:  In the developing countries, the patients often present late with advanced AIDS and very low CD4 cell count. The efficacy of antiretroviral therapy in advanced AIDS is noted but that and tolerability in very advanced cases with CD4 <50 cells/mm³ is scanty.

Methods:  A reprospective cohort study was conducted in HIV-infected patients who had been initiated HAART when CD4 <50 cells/mm³. Adverse events from medications, occurrence of opportunistic infection, and CD4 and HIV RNA at every 12 weeks until week 60 were studied.

Results: There were 159 patients (109 males) with mean age 36.6±8.5 years. 60.4% of the patients had previous major opportunistic infections. Baseline mean CD4 and median HIV RNA were 22 cells/mm³ and 260,000 or log 5.4 copies/mL, respectively. Majority (80%) of the patients had HIV RNA >100,000 copies/mL. Of 9 patients who developed opportunistic infections during the HAART, 6 were suspected of having immune reconstitution syndrome, and discontinued HAART; 22 patients had adverse drugs events, half of whom discontinued HAART; 5 patients were lost to follow-up; and 2 patients died of pancreatitis and PCP. Of the remainder, 148, 139, 138, 136, and 136 patients continued HAART and were followed at 12, 24, 36, 48, and 60 weeks, respectively. Mean CD4 at 12, 24, 36, 48, and 60 weeks were 95, 125, 166, 201, and 225 cells/mm³, respectively. The percentage of patients with HIV RNA <400 (<50) copies/mL at 12, 24, 36, 48, and 60 weeks were 88.5% (50%), 92.8% (71.2%), 92.8% (79.7%), 91.2% (79.4%), and 88.2% (80.1%), respectively. Adverse drug events included rash, dizziness, anemia, nausea/vomiting, fever, pancreatitis, and Steven-Johnson syndrome. Half of these needed to switch their HAART regimens to continue treatment.

Conclusions:  Initiation of HAART in advanced HIV-infected patients with CD4 <50 cells/mm³ is effective, safe, and well-tolerated. The antiretroviral therapy should not be delayed in these patients. However, adverse drug events and opportunistic infections during treatment should be aware and closed monitored.

Keywords: initiation; HAART; advanced