REKAMBYS (rilpivirine) - HIV-1 infection only in adolescents at least 12 years of age and weighing at least 35 kg

The clinical benefit of REKAMBYS (rilpivirine) 900 mg, suspension for injection, in combination with cabotegravir, is substantial only in adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen for at least six months, with a CD4 count of more than 200 cells per mm³, without present or past evidence of viral resistance to, and no prior virological failure with, agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class.

Considering:

• data previously assessed at the time of initial listing and reassessment (CT opinions of 21 April 2021 and 1 February 2023) having demonstrated non-inferiority of a switch from conventional triple therapy (oral triple therapy) to monthly prolonged-release injectable cabotegravir + rilpivirine dual therapy in adult patients who are virologically suppressed and with no history of failure or resistance, in terms of virological failure and immuno-virological response after 48 weeks of treatment;
• new pharmacokinetic data (MOCHA clinical study) having demonstrated:
  • equivalent exposure to treatment between adolescents and adults enabling the efficacy data to be extrapolated from adults to adolescents, in line with European guidelines on the clinical development of medicinal products for the treatment of HIV,
  • a long half-life of the products enabling an interval between doses,
  • a relatively favourable safety profile, despite being marked by a higher frequency of injection site reactions,
• the relatively low genetic barrier, particularly with respect to rilpivirine, with a risk of the emergence of resistance (>50%) to the medicinal products in the combination in the event of virological failure and cross-resistance to the 2 therapeutic classes (INI and NNRT);
• the lack of evidence of an impact of this simplification strategy in terms of improvement of morbidity and mortality, quality of life and compliance compared to continuation of conventional oral triple therapy or dual therapy;
• the absence of clinical data enabling assessment of the benefit of this dual therapy in patients with compliance difficulties, who could theoretically benefit from this strategy;

the Committee deems that REKAMBYS (rilpivirine) 900 mg suspension for injection provides no clinical added value (CAV V) in the treatment of HIV-1 infection in adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen for at least six months, with a CD4 count of more than 200 cells per mm³, without present or past evidence of viral resistance to, and no prior virological failure with, agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class compared to the available alternatives (oral triple therapies and dual therapies).