HIV competitive landscape UPDATES

Treatment

• Theratechnologies shared that the FDA has issued a refusal to file letter (RTF) regarding its supplemental Biologics License Application (sBLA) for the ibalizumab (Trogarzo) IM maintenance dose based on a preliminary review. (2/27)
  • The outcome was due to the Trogarzo sBLA “not [being] sufficiently complete” for a substantive review, with the RTF specifically stating that “the submitted data did not establish the pharmacokinetic bridge between the IM and the IV infusion route of administration”.
  • Additional Context: The sBLA filing for the Trogarzo IM maintenance dose was previously announced in January 2024, despite previously published results demonstrating that it failed to meet its primary endpoint measuring the ratio of IM injection to IV infusion.
• ViiV shared a press release on the NIAID-funded, ViiV-partnered Ph3 LATITUDE interim trial data, which demonstrated superior efficacy of CAB+RPV vs daily oral SOC in PLWH with adherence challenges (NCT03635788). (2/21)
  • Enrolled participants in the LATITUDE study received adherence support while taking 3DR oral ART to achieve viral suppression. They were then randomized to QM CAB+RPV or continued daily oral ART.
  • Based on interim results, the ACTG’s Data Safety Monitoring Board (DSMB) recommended that the LATITUDE study be modified to stop randomization and all eligible participants should be offered the option to transition to CAB+RPV.
    • The DSMB considered the totality of all study endpoints measuring efficacy, safety and durability in a planned interim review last week, and concluded that the evidence supported superior efficacy of CAB+RPV vs oral SOC.
  • A subsequent press release confirmed that LATITUDE interim data will be presented at CROI 2024.
  • Additional Context:
    • ViiV could leverage this data to support superiority claims, further bolster patient preference and adherence/persistence messaging. However, translation of economic incentives may be difficult to implement in the RW setting.
    • These results are also most likely not sufficient to influence guidelines or facilitate a label update.

Prevention

• The ANRS-sponsored Ph3 CABOPrEP trial comparing CAB for PrEP with oral TDF/FTC in MSM in France was listed on Clinicaltrials.gov (NCT06273943), with a PCD of October 30, 2025. (2/23)
  • The trial aims to recruit 322 participants from the ANRS-Prévenir cohort, who have previous experience on TDF/FTC, across 8 centers in the Paris region. Participants will be randomized 1:1 into TDF/FTC or CAB for PrEP arms.
  • The sole primary outcome measure is measuring adherence as the number of protocol visits completed at Month 12, with several secondary outcome measures including adherence at Month 24, discontinuation, safety, at-risk sexual activity, PROs, STIs, AEs, weight and metabolic outcomes, lipids, ISRs, efficacy and mental well-being.
  • The study protocol includes three ancillary studieswhich investigate participant perceptions, rectal tissue HIV-1 permissibility, and cost-effectiveness analysis for CAB for PrEP.

CROI 2024         

• ViiV shared a press release on the key data to be presented at CROI 2024, covering both its “innovative” pipeline and portfolio
  • The PR confirmed presentations on the CAB+RPV Ph3 LATITUDE trial, Ph1 Q4M CAB400 data, N6LS SC efficacy data from the Ph2a BANNER trial, and RWE across both treatment and prevention portfolios
  • ViiV had also previously launched a CROI 2024 microsite, highlighting ViiV’s focus on research and innovation, and developing medicines to suit patient need. This is supported by a short video with ViiV scientists discussing their commitment and passion for patients and HIV research. (2/26)

Franchise

• ViiV heavily promoted its new Dovato packaging on social media, emphasizing its impact on stigma, convenience, and patient choice, while also promoting stigma-related content from its #HIVinView campaign:
  • ViiV promoted its Dovato blister packaging option on its US Twitter, highlighting the stigma reduction, patient optionality and convenience benefits provided, based on its “small and discreet packaging”. (2/5-6)
• ViiV launched a new campaign to promote Apretude use:
  • Endpoints News shared an article on ViiV’s latest HIV PrEP awareness campaign called “Backseat Hotseat”, which features celebrity comedians as rideshare drivers chatting to passengers about their dating lives and ViiV PrEP options. (2/12)
    • The new 6-episode video series will be shared on the Apretude YouTube channel (Example episode).
    • The series aims to normalize PrEP, “especially among people disproportionately affected by HIV” according to Bithiah Lafontant, (Director of HIV prevention products and community communications, ViiV).

Label Updates

• Updates were made to the Rukobia label (Letter, Label), specifically regarding fostemsavir and ibalizumab cross resistance, temsavir activity, and updates to lactation and patient counselling (2/16)
  • Recommendations against breastfeeding have been removed from both the ‘Lactation’ and ‘Patient Information’ sections.
  • Under the ‘Resistance in Clinical Subjects’ section, E202 (glutamic acid (E) substitution at position 202 in gp120) was identified as a treatment-emergent substitution observed in a BRIGHTE study participant that can reduce susceptibility to temsavir and in some cases ibalizumab.
    • Temsavir was found to be “active against viruses resistant to enfuvirtide” and had “reduced activity against some CCR5-tropic, maraviroc-resistant viruses” though no “absolute correlation” was identified.