Double-dose lopinavir-ritonavir in combination with rifampicin-based anti-tuberculosis treatment in South Africa.

BACKGROUND: The optimal treatment for tuberculosis (TB) in human immunodeficiency virus (HIV) infected patients in resource-poor settings receiving lopinavir-ritonavir (LPV/r) based second-line antiretroviral therapy (ART) has yet to be determined. In South Africa clinicians are advised to use double-dose LPV/r dosed at 800 mg/200 mg twice daily during anti-tuberculosis treatment. METHODOLOGY AND PRINCIPLE FINDINGS: We conducted a retrospective study of HIV-infected patients who received >/=2 months of double-dose LPV/r-based ART during concomitant rifampicin-containing anti-tuberculosis treatment. We used standard definitions for TB and HIV outcomes; virological failure was defined as a viral load >1000 copies/ml. During co-administration gastro-intestinal toxicity occurred in 9/25 (36%) patients a symptomatic rise in aspartate aminotransferase or alanine aminotransferase of any grade was noted in 3 (12%) with two Grade 3 events and 3 (12%) patients required treatment discontinuation. Outcomes were favourable with 20/25 (80%) patients achieving TB treatment success and virological failure observed among 3 (12%) patients during co-administration. CONCLUSION: We found the use of double-dose LPV/r during simultaneous standard anti-tuberculosis treatment to be an effective and reasonably well tolerated interim strategy.