HIV competitive landscape

Treatment

• The EMA issued separate EU approvals for both Vocabria (cabotegravir) and Rekambys (rilpivirine)  for extended use in VS adolescents 
  • Both Vocabria and Rekambys are now indicated for the treatment of VS adults and adolescents aged ≥12 y/o and weighing ≥35 kg.
  • Extension was based on interim data from the Ph1/2 MOCHA clinical trial (NCT03497676), which assessed CAB+RPV in HIV-infected children and adolescents.
  • Following this label expansion, the Vocabria and Rekambys EU labels now match the indicated population in ViiV’s CAB+RPV US and Canada labels.

• Trial Update: The ViiV-sponsored Ph3 study evaluating the safety, tolerability, and PK of switch to CAB+RPV from current ART in VS PWH has advanced its SCD by 1 year to December 2025 from December 2026 (NCT02951052). (1/24)

Prevention

• ViiV listed a new Ph1 study assessing the PK, safety and tolerance of CAB Q4M following the administration of CAB Q2M in healthy adults (NCT06786520)
  • The trial started with 1 US site on January 22, 2025 with a target of 60 participants; PCD is February 10, 2027 and SCD is March 3, 2028.
  • In this single-arm study, participants will receive CAB Q2M injections up to Month 9, then CAB Q4M up to Month 23.
  • The primary outcome measure compares CAB plasma concentrations at Month 9 (end of the CAB Q2M phase) to Month 23 (end of the Q4M phase).
  • Secondary outcome measures include plasma concentration assessments at each Q4M assessment timepoint (up to Month 23), and AEs including ISRs (up to Month 32).

Pipeline

• Trial Update: Merck listed a new Ph1 trial (completed), which assessed DDIs of oral MK-8527 with a combined oral contraceptive (LNG/​EE) in healthy adult postmenopausal or ovariectomized female participants (NCT06783192). (1/21)
  • The trial included 14 participants in a single US site. The trial started on August 14, 2023 and was completed on October 11, 2023.

LMIC

• A Cambodian news outlet reported that Cambodia is preparing for the phased CAB for PrEP implementation in the country, which was revealed at a workshop on CAB for PrEP organized by the Cambodian Ministry of Health. (1/24)
  • The first phase of CAB for PrEP implementation will consist of 1000 doses “in the coming months”.
     
• NY times reported that the Trump administration halted disbursement of funds from a program that supplies most of the HIV treatment in Africa and developing countries worldwide, including the President’s Emergency Plan for AIDS Relief (PEPFAR) for at least 90 days. (1/24)

Franchise

• ViiV shared a video on its LinkedIn, demonstrating the use of AI in an initiative by ViiV Canada to ‘imagine the bright futures’ of three Canadian PWH. 
  • The video was centered around the topic of aging with HIV, emphasizing that with modern treatment options, PWH can lead healthy and fulfilling lives.