Original Title: Rifapentina + isoniazida para o tratamento da infecção latente pelo mycobacterium tuberculosis (ILTB)

Authors' objectives: The 3-month regimen of rifapentine plus isoniazid (3HP) is effective, safe and cost-effective, when compared to the 9-month regimen of isoniazid (9H), for the treatment of patients with Latent Mycobacterium Tuberculosis Infection (LTBI)?

Authors' results and conclusions: The Conitec’s members present at the 87th Ordinary Meeting, on June 3rd, 2020, unanimously decided to recommend the incorporation of rifapentine, to be used in combination with isoniazid in the 3HP regimen, for the treatment of patients with Latent Mycobacterium Tuberculosis Infection (LTBI), in the scope of SUS. The Deliberation Record No. 518/2020 was signed.

Authors' recommendations: Scientific evidence: Seven studies were retrieved: two randomized controlled trials (RCTs) and five observational studies. These studies showed statistically significant results favouring the 3HP regimen compared to the 9H regimen for the outcome of treatment completion (odds ratio [OR]=2.92; 95% confidence interval [CI]=2.07-4.12; I2=57%; p=0.03). For the outcome of reactivation of tuberculosis, the results were in favour of 3HP, but without statistical significance (risk ratio [RR]=0.47; 95% CI=0.2-1.12; p=0.09). As for the outcome of discontinuation due to Adverse Events (AE), flu-like symptoms were the most common AE in patients receiving 3HP, while hepatotoxicity was the most common AE for the 9H regimen. The results of the studies indicated rates of clinically relevant hepatotoxicity (Grade 3 and 4) in patients receiving 3HP regimen ranging from 0% to 1.5%, and higher rates in patients receiving 9H regimen ranging from 1.2% to 5.3% (Appendix 1). Budget impact analysis: A budget impact model was developed to estimate the costs associated with the incorporation of 3HP into SUS over a five-year time horizon (2020 to 2024). In the first scenario, the incremental budget impact of incorporating 3HP was estimated to be approximately BRL 1 million in 2020 and BRL 7.6 million after five years, in comparison with the baseline scenario. In the scenario with an overall discount for rifapentine, the incremental budget impact of incorporating 3HP was estimated to be approximately BRL 40,000 in 2020 and BRL 292,000 after five years (Appendix 3). Considerations: The use of 3HP is associated with a higher rate of LTBI treatment completion, and it has been shown to be a safe alternative to the treatment available in SUS. Moreover, the incorporation of 3HP appears to be feasible, cost-effective, with a low incremental budget impact, and without important limitations regarding implementation and acceptability.

Project Status: Completed

URL for project: http://conitec.gov.br/images/Consultas/Relatorios/EN2020/20201119_Report526_RifapentineIsoniazid_LatentMycobacteriumTuberculosisInfection.pdf

Year Published: 2020

URL for published report: http://conitec.gov.br/images/Consultas/Relatorios/2020/Relatorio_Rifapentina-Isoniazida_ILTB_526_2020_Final.pdf

URL for additional information: http://conitec.gov.br/recomendation-reports

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Brazil

Organisation Name: National Committee for Technology Incorporation (CONITEC)

Contact Address: Esplanada dos Ministérios, Bl. G, Ed. Sede, 8º andar, CEP: 70058-900

Contact Name: Clarice Moreira Portugal

Contact Email: clarice.portugal@saude.gov.br

Copyright: 2021 Conitec