Competitive Highlights at EACS 2023
EACS Guidelines Update
EACS released an update to its guidelines v12; the new guidelines added recommendations for CAB+RPV as a switch strategy.
Factors associated with CAB+RPV virologic failure, release of drug from the muscle, and recommendation for missed doses were summarized, and OLI made optional.
Guidelines recommend CAB for PrEP through a compassionate use program, for individuals for whom TDF/FTC is contraindicated.
Concerns about DTG & TAF were deleted from the pregnancy treatment options section.
HIV Treatment
DTG/3TC (Dovato) low forgiveness on variable dosing, using results from the DUETTO study
The French DUETTO study determined that 4/7 day dosing of DTG/3TC failed to achieve non-inferiority compared to 7/7 day dosing, highlighting the limited forgiveness to missed doses on the 2DR.
DTG/3TC (Dovato) in pregnant women, using results from the PREGNANCY study
A small pilot study concluded that DTG/3TC is safe and effective in pregnant women; however, KOLs believed this data to be premature and likely requires a larger follow-up trial to influence regulations and guidelines.
CAB+RPV (Cabenuva) risk of failure, resistance, and discontinuation in real-world studies - Dutch ATHENA national observational cohort, Swiss HIV Cohort Study
Real world cohorts in Europe have highlighted additional evidence for breakthrough VF and emergence of resistance on CAB+RPV, despite previously stably suppressed individuals with low risk factors and on-time injections.
Additional real-world evidence for CAB+RPV versus BIC/FTC/TAF continued to support non-inferiority yet excluded participants missing to follow-up from analysis.
CAB+RPV (Cabenuva) implementation, using results from the CARISEL study
ViiV’s latest CARISEL analyses provide insight into outcomes, and patient and clinician perceptions on a country level in the EU, providing insight into the LAI compatibility of various healthcare systems, and potential launch sequencing of CAB for PrEP.
N6LS (bNAb) monotherapy outcomes and PK/PD data from the BANNER study
The latest analyses from ViiV’s BANNER study supported continued development of N6LS as a CAB partner in the Ph2b EMBRACE study, demonstrating SC compatibility with Halozyme’s Enhanze delivery platform.
HIV Prevention
CAB for PrEP (Apretude) market shaping, using analysis of oral PrEP discontinuation
ViiV presented data from a European clinician survey which described high satisfaction with current oral PrEP options, but highlighted adherence to daily orals as the key reason for discontinuation, using results to underscore need for LA PrEP.
LA PrEP is highlighted as an alternative option addressing some of the limitations of current PrEP options, including stigma, fear of inadvertent disclosure and the requirement of taking daily oral pills. ViiV is likely to utilize this study to target PrEP users and non-PrEP users, with messaging focused on lifestyle benefits of CAB for PrEP, highlighting all the perceived negative reasons for daily orals.