IDWeek 2023: Key Conference Themes and Highlights - HIV Treatment & Prevention

Sunday, October 15^th, marked the conclusion of the IDWeek 2023 congress. A summary of the key competitive takeaways on HIV treatment & prevention is presented below.

HIV TREATMENT 

• CAB+RPV (Cabenuva) real world evidence regarding use in viremic populations, using data from the OPERA, TRIO, and BEYOND studies - ViiV presented the first real-world evidence for CAB+RPV in PLWH who were unsuppressed at baseline, demonstrating the existing clinician appetite to prescribe the regimen off-label. This observational data may not be able to support approval or guidelines inclusion, however, ViiV has indicated it is engaging with the FDA to explore ways to expand the label into this population. This builds off the Ward 86 data presented at CROI2023; however, KOLs expressed concern that in these real-world cohorts, CAB+RPV is being used in patients with high CD4 counts who have other treatment options, and unnecessarily exposes them to potential dual class resistance.

  • Real world studies assessed the utilization, effectiveness, and clinical outcomes of CAB+RPV in viremic populations, up to ≥ 200 copies/mL at baseline.

  • Off-label use of CAB+RPV in these populations demonstrated similar efficacy and adherence levels compared to those on the label. However, there was continued concern over cases of dual-class resistance. 

• CAB+RPV (Cabenuva) adherence and persistence, using results from the ABOVE study - ViiV is beginning to build adherence and persistence data for CAB+RPV, which could be leveraged to support its existing PRO-based messaging on patient benefit, while also building quantitative evidence to support payer negotiations. Though ViiV may not choose to highlight the 72% adherence to CAB+RPV in its communication of this data, it is probable that it will qualitatively emphasize the superior adherence of the LAI regimen versus orals.
• ViiV began crafting a narrative around the adherence and persistence benefits of CAB+RPV with data showing that that cohort had significantly higher adjusted odds of being adherent, compared to those taking daily orals.

• DTG/3TC (Dovato) vs BIC/FTC/TAF (Biktarvy) switch data, using interim data from the SOUND and DYAD studies
• As with the registrational studies, data demonstrated non-inferiority of DTG/3TC in VS adults, but failed to identify any points of competitive differentiation for switching to the 2DR.

HIV PREVENTION  

• CAB for PrEP (Apretude) implementation and market shaping, using data from EBONI and PILLAR - With no visibility on the designed implementation tools, ViiV’s choice to present EBONI and PILLAR SSP perspectives across 3 posters was likely a strategic decision to maximize its visibility at the conference and provide an opportunity to discuss the patient-centered trial design, specifically the focus on diverse populations, which is key messaging pillar for ViiV’s CAB for PrEP. Perceptions on CAB for PrEP implementation were generally positive, with ViiV showcasing their efforts to increase PrEP administration in high-risk populations. Despite ViiV’s efforts, the impact of its planned implementation program cannot be determined from current data. 

• • First implementation data from these trials were presented by ViiV across 3 posters, focused on identifying tools to support uptake in high-risk groups.
  • In collaboration with George Washington University, ViiV also presented a shared decision-making tool designed to mediate patient-provider discussions and systematize PrEP initiation across a broad scope of PWBP.

• CAB for (Apretude) access, using real world evidence from the CAN Community Health network - ViiV has acknowledged the financial barriers to CAB for PrEP access highlighted in this poster through the recent expansion and continued investment in its field reimbursement manager (FRM) team. FRMs work within ViiV’s patient assistance platform, ViiV Connect, to provide insurance negotiation and acquisition support to clinics. 

• • Early RWE revealed access and reimbursement barriers. Out of 293 people prescribed CAB for PrEP, only 52.9% were able to receive their first injection, with further discontinuations (4.5%) due to insurance coverage within the first 16 months of Apretude’s availability