H4. Treatment
Oral Abstract Submission
Paula Teichner, PharmD
Field Medical Director
ViiV Healthcare
Research Triangle Park, NC
Disclosure: ViiV Healthcare: Employee
Amy Cutrell, MS
Director Statistics
ViiV Healthcare
Research Triangle Park, NC
Disclosure: ViiV Healthcare: Employee
Ronald D'Amico, DO, MSc
Medical Director
ViiV Healthcare
Research Triangle Park, NC
Disclosure: ViiV Healthcare: Employee
David Dorey, MMATH
Statistician
GSK
Mississauga, ON, Canada
Disclosure: GlaxoSmithKline: Employee, Shareholder
Sandy Griffith, PharmD
Director Clinical Development
ViiV Healthcare
Research Triangle Park, NC
Disclosure: ViiV Healthcare: Employee, GSK shareholder
Conn M. Harrington, BA
Clinical Investigation Lead
ViiV Healthcare
Research Triangle Park, NC
Disclosure: ViiV Healthcare: Employee
Krischan J. Hudson, PhD, MPH
Director of Clinical Development
ViiV Healthcare
Research Triangle Park, NC
Disclosure: ViiV Healthcare: Employee
David Margolis, MD, MPH
Director of HIV Drug Development
ViiV Healthcare
Research Triangle Park, North Carolina
Disclosure: ViiV Healthcare: Employee, Shareholder, Other Financial or Material Support, Salary and stock options
Joseph Mrus, MD, MSc
Executive Medical Director
ViiV Healthcare
Cary, NC
Disclosure: ViiV Healthcare: Employee
Joseph Polli, PhD, FAAPS
Director, Medical Information and Scientific Communications
ViiV Healthcare
Research Triangle Park, NC
Disclosure: ViiV Healthcare: Employee, Shareholder
William Spreen, PharmD
R&D, Medicine Development Leader
ViiV Healthcare
Research Triangle Park, North Carolina
Disclosure: ViiV Healthcare: Employee
Peter Williams, Ph.D.
Dr
Janssen Research & Development, LLC
Beerse, Antwerpen, Belgium
Disclosure: Johnson & Johnson: Employee, Shareholder
Rodica Van Solingen-Ristea, MD
Clinical Leader
Janssen Research & Development, LLC
Beerse, Antwerpen, Belgium
Disclosure: Janssen: Employee
Mark S. Shaefer, PharmD
Global Medical Lead, Cabotegravir
ViiV Healthcare
Chapel Hill, NC
Disclosure: ViiV Healthcare: Employee
Background :
Cabotegravir (CAB) and rilpivirine (RPV) are under development as a novel long acting (LA) regimen for maintenance of HIV virologic suppression. Pooled Week 48 data from pivotal Phase 3 trials demonstrated non-inferiority of CAB LA + RPV LA vs. current antiretroviral regimen (CAR) on the primary endpoint, proportion of subjects with HIV-1 RNA ≥50 c/mL (1.9% and 1.7%, respectively). Adherence to dosing visits, use of oral dosing (bridging) to cover planned missed injections and injection tolerability were examined for subjects in the ATLAS & FLAIR studies.
Methods :
Virologically suppressed subjects (HIV-1 RNA < 50 c/mL) were randomized to switch to CAB LA + RPV LA or to continue CAR. On-time injections occurred Q4 weeks within a + 7-day dosing window of the projected dosing date. Adherence to LA therapy was calculated as the number of on-time injection visits divided by the number of expected dosing visits through Week 48. Injection visits outside the pre-specified window and missed injection visits with/without use of oral dosing were quantified. Injection tolerability was assessed via adverse event reporting.
Results :
14,682 injections of CAB and RPV were administered to 581 subjects during 6,920 injection visits. 98% of injection visits took place within the allowed ± 7-day dosing window with 3194 (46%) on the projected dosing date. 46 (<1%) injection visits were early and 106 (2%) were late. Oral bridging was used in 16 subjects overall; 8 planned missed injection visits were successfully covered, with no change to virologic suppression status. No subject with HIV-1 RNA ≥ 50 c/mL at Week 48 had missed/late injection visits. 25% (3663/14,682) of injections were associated with local injection site reactions (ISRs). The most common ISR was pain (3087/3663=84%). Most ISRs were grade 1-2 (99%), short duration (median 3 days), with few associated discontinuations (<1%).
Conclusion :
Subjects receiving CAB LA + RPV LA demonstrated high rates of adherence to injection visits through week 48, with 98% of injections occurring within the ± 7-day dosing window. Oral bridging with CAB and RPV was an effective strategy for maintaining viral load suppression to cover missed injection visits. Injections were well-tolerated with few associated discontinuations.
