Brazil Sets Ceiling Price for Long-Acting HIV Prevention Injection
Brazil’s drug pricing regulator has established a maximum consumer price of R$20,900 per injection for lenacapavir, a long-acting injectable medication designed to prevent HIV infection, as reported by Folha de S.Paulo. The decision by the Chamber of Regulation of the Medicinal Market sets a cost ceiling for the product, which requires administration every six months. This regulatory action arrives roughly nine months after the Brazilian Health Regulatory Agency authorised the preventive use of the medication under the brand name Sunlenca. While the price now appears on the agency’s official consultation system, physical availability in pharmacies remains pending while manufacturer Gilead Sciences establishes domestic distribution and sales channels.
Clinical Trial Results Compare Injectable and Oral Prevention Options
Clinical data published in The Lancet HIV demonstrate that injectable pre-exposure prophylaxis using cabotegravir achieved high coverage rates among trial participants. By comparison, users of oral pre-exposure prophylaxis currently distributed by the public health system achieved a coverage rate of 35.5%, as reported by Observatório G and Agência Aids. The study tracked 1,201 participants aged 18 to 30 across six Brazilian capitals between October 2023 and September 2024. The research gathered gay men and other men who have sex with men, non-binary individuals, and trans men and women. Among 1,447 participants who were able to select their method, 1,201 chose the injectable option. For those who selected oral pre-exposure prophylaxis within the study, the coverage rate reached 47.3% of follow-up days. Adherence to the injections was also high, with 92% of doses administered within the scheduled study timeframe.
Public Health Integration and Ongoing Negotiations
Integration of long-acting HIV prevention into the Unified Health System depends on separate evaluations by the National Commission for the Incorporation of Technologies and subsequent decisions by the Ministry of Health, according to Folha de S.Paulo. The regulator establishes commercial price ceilings, whereas the ministry negotiates distinct acquisition costs for public distribution.
Frequently Asked Questions
Who is eligible to receive lenacapavir under the Brazilian Health Regulatory Agency approval?
The regulatory agency authorised the preventive use of lenacapavir for adults and adolescents aged 12 and older with a minimum weight of 35 kilograms, according to Folha de S.Paulo. Clinical trials presented to regulators demonstrated efficacy of up to 100% in specific research cohorts.
How are the injectable medications administered in clinical practice?
Lenacapavir requires semiannual injections administered in the abdomen by healthcare professionals. In contrast, other experimental long-acting regimens evaluated in Brazil, such as cabotegravir and rilpivirina combinations, are applied in the gluteus.
What were the infection rates observed in the Fiocruz cabotegravir study?
Researchers recorded an HIV incidence of 0.20 cases per 100 people-years among participants receiving cabotegravir, resulting in three total infections during the study period. Two of those infections occurred in individuals whose injections were up to date, with resistance to integrase inhibitors identified in only one instance. In the comparison cohort composed of users of oral pre-exposure prophylaxis provided by the public health system, 18 infections were identified, corresponding to an incidence of 1.48 cases per 100 person-years.
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