Original Title: Dolutegravir para o tratamento de gestantes vivendo com HIV

Authors' objectives: Is the use of dolutegravir 50 mg, in combination with other antiretroviral drugs, effective, safe and cost-effective for the treatment of pregnant women living with HIV in initiation of ART, when compared with raltegravir 400 mg?

Authors' results and conclusions: The CONITEC’s members present at the 85th Ordinary Meeting, on February 5th, 2020, unanimously decided to recommend the expansion of the use of dolutegravir for the treatment of pregnant women living with HIV from the second trimester of pregnancy. The Deliberation Record No. 506/2020 was signed.

Authors' recommendations: Scientific evidence: The use of integrase inhibitors in pregnancy was not recommended in the Clinical Protocol and Therapeutic Guidelines for the Management of HIV Infection in Adults, 2017, due to uncertainties about their safety – initial studies had highlighted a possible link between dolutegravir (DTG) and neural tube defects in infants born to women using the drug at the time of conception. In a study conducted in Botswana by Zash et al. (2019), the prevalence of neural tube defects associated with using DTG was 0.30%. The National Cohort Study of Dolutegravir and Pregnancy Outcomes in Brazil was conducted on women living with HIV (WLHIV) who became pregnant while taking ART regimens containing DTG, efavirenz (EFZ) or raltegravir (RAL). Of the 1,468 women included in the study, 382 were DTG-exposed, compared with 1,086 EFZ- or RAL-exposed, and no neural tube defects (NTDs) were detected in either exposure group. Modeling studies on the risks and benefits of DTG in WLHIV of reproductive potential in initiation of ART suggested that the advantages of DTG of greater and more rapid maternal viral suppression, and reduction of both sexual and vertical transmission of HIV, outweigh the risks related to NTDs. Budget impact analysis: The budget impact of replacing raltegravir 400 mg twice daily with dolutegravir 50 mg once daily, in the initial ART regimen in pregnant women, has been estimated at a saving of BRL 24,908,344.38 in the first year (2020), which would continue for the next four years. Thus, at the end of five years (2020-2024), the accumulated savings would be BRL 124,846,181.19 with dolutegravir 50 mg as the drug of choice to start ART during pregnancy. Considerations: Dolutegravir 50 mg is an antiretroviral drug already incorporated into the Brazilian Public Health System (SUS) for the treatment of people living with HIV. In the study by Zash et al. (2019), dolutegravir 50 mg showed a risk of neural tube defects of 0.3%, compared with 0.1% in the general population. But according to the study of Pereira et al. (2019), in Brazil there were no NTDs among the 382 cases of periconceptional exposure to DTG, and similar results have been found in studies conducted in France and Canada. In regard to the economic evaluation, dolutegravir 50 mg replacing raltegravir 400 mg proved to be less expensive in the cost-minimization analysis.

Project Status: Completed

URL for project: http://conitec.gov.br/images/Consultas/Relatorios/EN2020/20200915_Report515_Dolutegravir_Pregnant-HIV.pdf

Year Published: 2020

URL for published report: http://conitec.gov.br/images/Relatorios/2020/Relatorio_Dolutegravir_Gestante_HIV_515_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

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