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Abstract
TB/HIV co-infected patients on rifampicin containing treatment have equivalent ART treatment outcomes, and concurrent use of nevirapine is not associated with increased hepatotoxicity
Van Cutsem G.1, Cohen K.2, Bedelu M.1, Sarunchuk P.1, Hilderbrand K.1, Coetzee D.3, Boulle A.3
1Médecins Sans Frontières, Cape Town, South Africa, 2Provincial Government of the Western Cape, Cape Town, South Africa, 3University of Cape Town, Cape Town, South Africa
Introduction: This study explores the impact of concurrent rifampicin-based tuberculosis therapy on ART treatment outcomes and nevirapine tolerability.
Methods: Prospective cohort study of all treatment-naïve adults started on ART in Khayelitsha (South Africa) by the end of 2004. Exposures include concomitant tuberculosis at the time of starting ART, the duration on tuberculosis treatment, and nevirapine presence in the ART regimen. Outcome measures include survival, virological suppression, CD4 count gain, and liver enzyme changes.
Results: Over 1,000 treatment-naïve adults had started ART by the end of 2004. Preliminary data from 670 patients started on ART by the end of 2003 revealed that being on tuberculosis treatment when starting ART (n=153) was not associated with worse survival (multivariate HR for death 0.86, IQR 0.43 – 1.31). The proportion of patients with virological suppression at 3, 6 and 12 months on ART did not differ by tuberculosis treatment status when starting ART. Increases in CD4 count were equivalent between the groups at 6 and 12 months duration on ART (142 vs. 149 cells/µl gained at 6 months). Grade 3 and 4 increases in alanine aminotransferase (ALT) in patients on nevirapine were few (5.7% cumulative proportion), and were not associated with concurrent rifampicin use in this cohort.
Conclusions: Although there are many studies reporting high rates of tuberculosis immune reconstitution syndrome, concurrent tuberculosis treatment in this cohort has not to date been associated with inferior clinical outcomes when looking at survival, and virological and immunological outcomes. There is ongoing concern about the concurrent use of rifampicin and nevirapine in terms of hepatotoxicity. The lack of an association between the concurrent use of these drugs and increases in ALT in this observational study are encouraging should pharmacokinetic studies (ongoing) endorse their use together.
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