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Conitec Begins Review of Injectable HIV PrEP for Brazil's SUS

Regulators will weigh Brazilian trial evidence showing high adherence with zero infections among injectable users against price concerns.

Overview

  • GSK/ViiV, backed by the Sociedade Brasileira de Infectologia, filed the request on September 12 for cabotegravir to be offered through SUS, triggering Conitec’s safety, efficacy and cost-effectiveness assessment before a Health Ministry decision.
  • Cabotegravir is administered every two months and was approved by Anvisa in 2023, reaching Brazil’s private market in August 2025.
  • Fiocruz’s ImPrEP CAB study with about 1,400 participants reported 83% preference for injections, 94% on-time dosing and no HIV infections among injectable users, compared with lower protection days and one infection in the oral-PrEP group.
  • Pricing remains a key hurdle to incorporation, with experts citing price inadequacy as a barrier, and there is no stated timeline yet for public consultation or a final decision.
  • SUS has offered daily oral PrEP since 2017 and counts about 119,000 users this year, while official data show 46,495 new HIV notifications in 2023, with more than 40% among men aged 20 to 29.