116 - Antiviral Activity and Safety of Long-acting Cabotegravir (CAB LA) Plus Long-acting Rilpivirine (RPV LA), Administered Every 2 Months (Q2M), in Hiv-positive Subjects: Results from the POLAR Study

Background: Long-acting (LA) cabotegravir (CAB) and rilpivirine (RPV) injectable suspensions have demonstrated efficacy in phase III studies. POLAR assessed antiviral activity and safety of CAB LA+RPV LA, administered every 2 mos (Q2M), in HIV-1 infected, antiretroviral therapy–experienced adults who completed LATTE and received once-daily oral CAB30mg+RPV25mg treatment.

Methods: POLAR is a phase IIb, multicenter, open-label, rollover study in 97 virologically suppressed, HIV-infected adults. LATTE participants who completed ≥312 weeks on study, with plasma HIV-1RNA< 50c/mL at screening, were eligible for POLAR and offered the option to switch to CAB LA+RPV LA Q2M or to the oral fixed dose combination of dolutegravir (DTG)/rilpivirine (RPV) once daily, for continued maintenance of HIV-1RNA suppression. 90 participants chose CAB LA+RPV LA and 7 participants chose oral DTG/RPV. The primary outcome measure was proportion of participants with plasma HIV-1RNA≥50c/mL after 12 mos (M12) of therapy. Safety and laboratory measures were assessed throughout the study. Participants selecting LA treatment completed satisfaction and quality-of-life questionnaires at Day 1, M6, and M12.

Results: At M12, no participant had HIV-1RNA≥50c/mL or protocol defined virologic failure (confirmed plasma HIV-1RNA > 200c/mL). Excluding injection-site reactions (ISRs), nasopharyngitis (11%), upper respiratory tract infection (11%), diarrhea (10%), and pyrexia (10%) were the most commonly reported adverse events (AEs) in the Q2M arm. 10% (9/90) of Q2M participants reported AEs ≥grade 3; 0 were drug related. 2% (2/90) of Q2M participants had AEs leading to withdrawal. 6% (5/90) of participants reported serious AEs (1 considered drug-related). Over 12 mo, 1534 injections were administered; 463 ISRs were reported (30%; all grade 1/2 [84%/16%]); resolution of ISRs occurred after a median of 3 days. Minimal changes in lab parameters were observed in participants across 12 mo. 88% of participants who received LA therapy preferred CAB LA+RPV LA vs oral therapy.Table 1
Table 2


Conclusion: CAB LA+RPV LA, administered Q2M, resulted in durable virologic suppression, an acceptable tolerability profile, and high levels of participant satisfaction over the first 12 mo of treatment in POLAR.

Presenting Author(s)

• 

  Anthony Mills, MD

  Chief Executive Officer/ Principal Investigator
  Men’s Health Foundation/ Mills Clinical Research
  Los Angeles, CA

  Disclosure: Gilead (Grant/Research Support, Advisor or Review Panel member)Janssen Pharmaceutica (Grant/Research Support, Advisor or Review Panel member)Merck (Grant/Research Support, Advisor or Review Panel member)Shionogi (Grant/Research Support)ViiV Healthcare (Grant/Research Support, Advisor or Review Panel member)

  Slides Slides and Audio

Co-Author(s)

• GR

  Gary J. Richmond, MD, FACP, FCCP

  Clinical Assistant Professor
  Nova Southeastern University
  Fort Lauderdale, Florida

  Disclosure: Gilead (Scientific Research Study Investigator)TaiMed (Scientific Research Study Investigator)Viv (Scientific Research Study Investigator)
• CN

  Cheryl Newman, MD

  Professor of Medicine
  Augusta University
  Augusta, Georgia

  Disclosure: Gilead (Grant/Research Support)GlaxoSmithKline (Grant/Research Support, Speaker's Bureau)ViiV Healthcare (Research Grant or Support, Speaker's Bureau)
• OO

  Olayemi Osiyemi, M.D

  President
  Triple O Research Institute PA
  West Palm Beach, Florida

  Disclosure: GlaxoSmithKline (Advisor or Review Panel member, Speaker's Bureau)ViiV Healthcare (Advisor or Review Panel member, Speaker's Bureau)
• JC

  Jerry Cade, MD

  Medical Director
  University Medical Center of Southern Nevada
  Las Vegas, Nevada

  Disclosure: Gilead (Consultant, Research Grant or Support, Speaker's Bureau)Janssen Pharmaceutica (Consultant)Merck (Consultant, Research Grant or Support, Speaker's Bureau)ViiV Healthcare (Consultant, Research Grant or Support)
• CB

  Cynthia Brinson, MD

  Medical Director
  Central Texas Clinical Research
  Austin, Texas

  Disclosure: Gilead (Advisor or Review Panel member, Speaker's Bureau)ViiV Healthcare (Advisor or Review Panel member, Speaker's Bureau)
• JD

  Jerome De Vente, MD

  Principle Investigator
  Long Beach Education and Research Consultants
  Long Beach, California

  Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
• NA

  Nisha Andany, MD, MPH, FRCPC

  Infectious Disease Specialist
  Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada

  Disclosure: Gilead Sciences (Scientific Research Study Investigator)GlaxoSmithKline (Scientific Research Study Investigator)Janssen (Scientific Research Study Investigator)
• DM

  David Margolis, MD, MPH

  Director of HIV Drug Development
  ViiV Healthcare
  Research Triangle Park, North Carolina

  Disclosure: GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)
• KS

  Kenneth Sutton, MA

  Clinical Development Manager
  ViiV Healthcare
  Research Triangle Park, North Carolina

  Disclosure: GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)
• VW

  Viviana Wilches, HBSc, MBiotech

  Clinical Development Manager
  GlaxoSmithKline
  Collegeville, Pennsylvania

  Disclosure: GlaxoSmithKline (Employee, Shareholder)
• JR

  Jeremy Roberts, MSc

  Manager, Statistics
  GlaxoSmithKline
  Mississauga, Ontario, Canada

  Disclosure: GSK (Employee)
• CM

  Cynthia C. McCoig, MD

  Director, R&D
  ViiV Healthcare
  Tres Cantos (Madrid), Madrid, Spain

  Disclosure: ViiV Healthcare (Employee)
• KV

  Kati Vandermeulen, M.SC.

  Senior Director
  Janssen R&D
  Beerse, Antwerpen, Belgium

  Disclosure: Janssen Pharmaceutica (Employee, Shareholder)
• WS

  William Spreen, PharmD

  R&D, Medicine Development Leader
  ViiV Healthcare
  Research Triangle Park, North Carolina

  Disclosure: ViiV Healthcare (Employee, Shareholder)