Summary of evidence and Expert Committee recommendations
The WHO Department of HIV has submitted a proposal for the inclusion of a new strength FDC containing sulfamethoxazole 800 mg and trimethoprim 160 mg, for the prevention of P. jiroveci in adults living with HIV. The proposal is generally consistent with WHO treatment guidelines for use of sulfamethoxazole-trimethoprim (co-trimoxazole). Several strengths of the FDC are already included on the EML.
The application provides a summary of three clinical trials in adults infected with HIV, comparing treatment with sulfamethoxazole 800 mg and trimethoprim 160 mg with placebo. At 46 months, those receiving active treatment had a significantly lower risk of mortality compared with placebo (RR 0.65; 95% CI 0.56–0.76). The overall quality of evidence for the benefits of the intervention is assessed as high. Adverse events from treatment were not significantly different between the two groups. Costs for the FDC tablet range from US$ 0.0186 to US$ 0.0308 per day.
The Committee noted that the proposal is supported by the Director of the Stop TB Department, WHO.
The Committee recommended inclusion of the additional strength FDC on the EML.