Objective: To study the safety and antiretroviral efficacy of concomitant use of rifampicin (RMP) and efavirenz (EFV) in antiretroviral-naïve tuberculosis (TB) co-infected HIV-1 patients (pts) in India.

Background: Tertiary care HIV clinic, Ahmedabad, India. Observational, longitudinal, cohort study. TB co-infected HIV-1 pts have limited options for protease inhibitor-containing antiretroviral therapies (ARTs). Concomitant use of RMP (an anti-TB drug) and EFV (an NNRTI) is possible. However, limited data exist on the clinical experience of co-administration of RMP with EFV.

Methods: Two (2) groups of ART-naive HIV-infected subjects were initiated on 2NRTIs [d4T/3TC (n = 166) or AZT/3TC (n = 31)] + EFV (generic antiretroviral agents). Group A subjects with TB co-infection receiving RMP-based anti-TB therapy and Group B without TB. Clinical evaluations were performed monthly and CD4/CD8 counts quarterly. The main outcome measurement was CD4 count at 9 months (mos).

Results: We further analyzed 197 out of 211 subjects who completed a minimum of 9 mos of follow-up (9 and 5 subjects from Gp A and Gp B, respectively, were lost). The subject characteristics are as follows:

Group	Male/ Female	Age (yrs)	Initial CD4	3 mo CD4	6 mo CD4	9 mo CD4
A (n = 98)	79/19*	35	104**	247	276	306***
B (n = 99)	67/32	38	130	273	278	270

*male/female, p = 0.056, Chi-square test; **initial CD 4, p = < 0.0001; *** 9 mo CD4, p = < 0.0001, ANOVA test.

 

The results show that in TB group, there were more men then women and baseline CD4 count was low. Significant increase in CD4 count was seen in both the groups with ART, and at 9 mos CD4 counts in the TB subjects were higher than non-TB subjects. EFV-related side effects were observed in 34 subjects (16.24%) (giddiness = 12, headache = 12, night dreams = 8, skin rash = 2). Paradoxical worsening was observed in 8 pts (8.16%) in-group A.

Conclusions: This is the first observational study to date from India documenting the safety and antiretroviral efficacy of concomitant use of RMP and EFV amongst TB co-infected pts in clinical practice. Co-administration of RMP with EFV is well tolerated and doesn’t affect antiretroviral potency as measured by rise in CD 4 counts. In India and other countries where TB is a common opportunistic infection, EFV-based therapy can be offered along with RMP-based anti-TB treatment.