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Background:   Generic production of ART in India has resulted in significant price reductions. With TB being endemic to the region, EFV+3TC+d4T is the most economical option in HIV/TB co-infection (USD 1/day), followed by EFV+3TC+AZT (USD 1.5/day). With better awareness of treatment options and health care worker education, patients are detected in relatively earlier stage of HIV disease (CD4 >250) as compared with earlier (CD4 <200 with varying degrees of bone marrow suppression), allowing use of AZT in place of d4T. This study compares outcome of AZT vs d4T along with 3TC+EFV plus rifampicin-based ATT.

Methods:  This is a comparative observational longitudinal study of cohorts comprising of patients with HIV/TB co-infection who opted for either d4T+3TC+EFV (n = 36) or AZT+3TC+EFV (n = 24)  along with rifampicin-based ATT with respect to tolerability and clinical and immunological success followed for 24 months in our tertiary HIV referral center in Mumbai. Clinical assessment was monthly and CD4/CD8 lymphocyte enumerations half yearly; we used Wilcoxon signed rank to compare paired CD4 counts within patients and Mann-Whitney to compare CD4 counts from baseline between the 2 study groups.

Results:  There was no mortality in either arm. A significant rise in serially enumerated CD4 lymphocyte counts was seen in both groups over baseline values with median increments of 53 cells (n =36, p  <0.001), 92 (n = 34, p <0.001), 148 cells (n = 29, p <0.01), and 163 cells (n = 32, p <0.001); over median baseline value of 160 (range 93 to 343) in the d4T group and median increments of 69 cells (n = 24, p <0.001), 85 cells (n = 24, p <0.001), 130 cells (n = 23, p <0.001), and 197 cells (n = 22, n <0.001);  over median baseline value of 194 (range 160 to 310) in the AZT group at the end of 6, 12, 18, and 24 months, respectively. There was no significant difference in CD4 increments between 2 treatment arms. In the AZT group adverse events included:  gastritis (3), anemia (2), giddiness and bad dreams (2), and hepatitis (1). In the d4T arm, adverse events included:   peripheral neuropathy (6); giddiness and bad dreams (3); by the end of 1 year, lipoatrophy (12); and, by end of 2 years,  lipodsytrophy (28:  26 lipoatrophy, 2 central adiposity and lipoatrophy).

Conclusions:  Even though d4T-based regimen is more economical than the AZT-based regimen, with comparable immunological and clinical outcome, the consequent high incidence of lipoatrophy  limits long-term use.

Keywords: lipoatrophy; d4T