Adverse events and treatment interruption in tuberculosis patients with and without HIV co-infection RAM

Rationale: Serious treatment-associated adverse events are thought to occur more frequently in individuals with tuberculosis who are co-infected with HIV. Objectives and Methods: To assess the frequency of serious (Grade III/IV) adverse events and interruption of anti-tuberculosis treatment in the era of effective anti-retroviral therapy. We retrospectively compared the incidence of serious (Grade III/IV) adverse events in 312 individuals treated for tuberculosis, of whom 156 were co-infected with HIV. Results: 111 (71%) of HIV-infected individuals received highly active antiretroviral therapy at the same time as anti-tuberculosis treatment. Serious (Grade III/IV) adverse events were recorded in 40% HIV infected and 26% HIV-uninfected individuals respectively (p=0.008). Peripheral neuropathy and persistent vomiting were more common in co-infected patients (p<0.001; p=0.006); although all cause interruption of anti-tuberculosis therapy occurred with similar frequency within each group (13% in the HIV-infected and 15% in the HIV-uninfected groups; p=0.74). In 85% of HIV-infected and 87% of HIVuninfected individuals respectively this was due to hepatotoxicity, which typically presented within two months of starting treatment. The median delay in restarting therapy was 4 weeks; thus most individuals required full tuberculosis re-treatment. Conclusion: Despite a greater rate of serious (Grade III/IV) adverse events among HIV infected individuals, we found that discontinuation of antituberculosis treatment occurred with similar frequency in HIV-infected and HIV-uninfected individuals. Word Count: 214