6.2 Justification and evidence

The recommendation in this section addresses one PICO question:

PICO question 12 (DR-TB, 2011): In patients with HIV infection and drug-resistant TB receiving antiretroviral therapy, is the use of drugs with overlapping and potentially additive toxicities, compared with their avoidance, more or less likely to lead to cure or other outcomes?⁵⁶

Evidence was reviewed from 10 studies (100–109) to assess patient treatment outcomes when ART and second-line antituberculosis drugs were used together. None of the data were from RCTs. Individual patient data were available for 217 drug-resistant TB patients in total, of whom 127 received ART. The level of evidence in individual observational studies varied from a low to a very low quality.

⁵⁶ The outcomes considered for this question comprised: 1. Cure (treatment failure), 2. Prompt initiation of appropriate treatment, 3. Avoiding the acquisition or amplification of drug resistance, 4. Survival (death from TB), 5. Staying disease-free after treatment; sustaining a cure (relapse), 6. Case-holding so the TB patient remains adherent to treatment (default or treatment interruption due to non-adherence), 7. Population coverage or access to appropriate treatment of drug-resistant TB, 8. Smear or culture conversion during treatment, 9. Accelerated detection of drug resistance, 10. Avoidance of unnecessary MDR-TB treatment, 11. Population coverage or access to diagnosis of drug-resistant TB, 12. Prevention or interruption of transmission of drug-resistant TB to other people, including other patients and health care workers, 13. Shortest possible duration of treatment, 14. Avoiding toxicity and adverse reactions from antituberculosis drugs, 15. Cost to the patient, including direct medical costs and other costs such as transportation and lost wages due to disability, 16. Resolution of TB signs and symptoms; ability to resume usual life activities, 17. Interaction of antituberculosis drugs with non-TB medications, and 18. Cost to the TB control programme.

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