Abstract
BackgroundAdministration of rifampicin along with nevirapine reduces the plasma concentration of nevirapine in human immunodeficiency virus positive individuals with concomitant tuberculosis (HIV-TB patients). Nevirapine is a much cheaper drug than its alternative efavirenz, and might be beneficial in resource constrained settings.MethodsA randomised open label trial was conducted at All India Institute of Medical Sciences, New Delhi, India. During the regimen of an antiretroviral therapy (ART), naive HIV-TB patients were randomly assigned to receive either nevirapine or efavirenz based ART with concomitant rifampicin based anti-tubercular therapy (ATT). Participants were followed for 24 months after starting ART. The end points were virological, immunological and clinical responses, and progression of HIV disease marked by failure of ART.ResultsOf the 135 HIV-TB patients, who were receiving rifampicin based ATT, 68 were selected randomly to receive efavirenz based ART and 67 to receive nevirapine based ART. The virological failure rates in the overall population, and the nevirapine and efavirenz groups were 14.1% (19/135); 14.9% (10/67) and 13.2% (9/68), respectively (p = 0.94). No significant difference was found between the groups in the rate of clinical, immunological or virological failures. The overall mortality was 17% with no significant difference between the two groups. Except for the lead in period on day 14, the mean nevirapine concentration remained above 3 mg/L. No association was found between plasma levels of nevirapine and incidence of unfavourable outcomes in this group.ConclusionsOutcome of ART in HIV-TB patients on rifampicin based ATT showed no significant difference, irrespective of whether efavirenz or nevirapine was used. Therefore, nevirapine based ART could be an alternative in the resource limited settings in patients with HIV and tuberculosis co-infection.Trial registrationNCT No. 01805258.
Highlights
Administration of rifampicin along with nevirapine reduces the plasma concentration of nevirapine in human immunodeficiency virus positive individuals with concomitant tuberculosis (HIV-TB patients)
According to the current WHO HIV treatment guidelines and the National AIDS Control Organisation (NACO) guidelines for India, efavirenz-based Antiretroviral therapy (ART) is a preferred first-line regimen in HIV/TB co-infected patients already receiving rifampicin-containing anti-tubercular therapy (ATT) regimen, because of the lower drug-drug interactions when compared with nevirapine or protease inhibitors (PIs) [4,5]
Nevirapine is frequently used in India in HIV/AIDS patients as a component of first line regimens, which is available as fixed drug combinations
Summary
Administration of rifampicin along with nevirapine reduces the plasma concentration of nevirapine in human immunodeficiency virus positive individuals with concomitant tuberculosis (HIV-TB patients). According to the current WHO HIV treatment guidelines and the NACO guidelines for India, efavirenz-based ART is a preferred first-line regimen in HIV/TB co-infected patients already receiving rifampicin-containing ATT regimen, because of the lower drug-drug interactions when compared with nevirapine or protease inhibitors (PIs) [4,5]. Rifampicin, a potent cytochrome P450 enzyme inducer, which reduces the plasma concentrations of nevirapine, is still an important drug prescribed for the treatment of TB in many resource limited countries like India. This drug is usually administered for 6 to 8 months as a part of ATT to reduce the relapse of TB in HIV-TB co-infected patients. Rifabutin has fewer problematic drug interactions, it is not available in many resource limited countries including India
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