638 - Safety, Efficacy, and Durability of Long-Acting CAB and RPV as Maintenance Therapy for HIV-1 Infection: LATTE-2 Week 256 Results

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Presenting Author(s)

GS

Graham Smith

Dr
Maple Leaf Medical CLinic
Toronto, Ontario, Canada
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Co-Author(s)

KH

Keith Henry

Staff MD
Hennepin County Medical Center
Minneapolis, Minnesota
Disclosure: Gilead (Research Grant or Support, Paid to institution)GSK/ViiV (Research Grant or Support, Paid to institution)Janssen (Research Grant or Support, Paid to institution)Merck (Research Grant or Support, Paid to institution)
DP

Daniel Podzamczer

Chief, HIV Unit
Hospital Bellvitge
Barcelona, Catalonia, Spain
Disclosure: Gilead (Grant/Research Support, Advisor or Review Panel member)Janssen Pharmaceutica (Grant/Research Support, Advisor or Review Panel member)Merck Sharp & Dohme (Grant/Research Support, Advisor or Review Panel member)ViiV Healthcare (Grant/Research Support, Advisor or Review Panel member)
MM

Mar Masiá

Infectious Disease Specialist
Hospital General Universitario de Elche
Elche, Comunidad Valenciana, Spain
Disclosure: Janssen Pharmaceutica (Consultant, Other Financial or Material Support, Travel/accommodations/meeting expenses)Merck Sharp & Dohme (Consultant, Other Financial or Material Support, Travel/accommodations/meeting expenses)ViiV Healthcare (Consultant, Other Financial or Material Support, Travel/accommodations/meeting expenses)
CB

Christopher Bettacchi

Infectious Diseases Physician
North Texas Infectious Disease Consultants
Dallas, Texas
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
KA

Keikawus Arasteh

Priv. Dr. med
EPIMED
Berlin, Berlin, Germany
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
HJ

Hans Jaeger

Medical Director
MVZ Karlsplatz - HIV Research and Clinical Care Centre
Munich, Bayern, Germany
Disclosure: Abbvie (Consultant, Speaker's Bureau)Gilead Sciences (Consultant, Speaker's Bureau)Janssen (Consultant, Speaker's Bureau)MSD Sharp & Dohme (Consultant, Speaker's Bureau)ViiV Healthcare (Consultant, Research Grant or Support, Speaker's Bureau)
MK

Marie-Aude Khuong-Josses

MD
Hopital Delafontaine
Saint-Denis, Ile-de-France, France
Disclosure: Viiv HC (Advisor or Review Panel member)
KS

Kenneth Sutton

Clinical Development Manager
ViiV Healthcare
Research Triangle Park, North Carolina
Disclosure: GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)
FZ

Feifan Zhang

Statistician
GlaxoSmithKline
Collegeville, Pennsylvania
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
CM

Cynthia C. McCoig

Director, R&D
ViiV Healthcare
Tres Cantos (Madrid), Madrid, Spain
Disclosure: ViiV Healthcare (Employee)
KV

Kati Vandermeulen

Senior Director
Janssen R&D
Beerse, Antwerpen, Belgium
Disclosure: Janssen Pharmaceutica (Employee, Shareholder)
RV

Rodica Van Solingen-Ristea

Clinical Leader
Janssen Research & Development, LLC
Beerse, Antwerpen, Belgium
Disclosure: Janssen R&D (Employee)
WS

William Spreen

R&D, Medicine Development Leader
ViiV Healthcare
Research Triangle Park, North Carolina
Disclosure: ViiV Healthcare (Employee, Shareholder)
DM

David Margolis

Director of HIV Drug Development
ViiV Healthcare
Research Triangle Park, North Carolina
Disclosure: GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)

Background: Long-acting (LA) injectable suspensions of cabotegravir (CAB) & rilpivirine (RPV) are in phase III development. LATTE-2 W160 results demonstrated high rates of virologic response & overall tolerability. This W256 analysis evaluated long-term efficacy, safety, & tolerability of every 8-week (Q8W) & 4-week (Q4W) intramuscular (IM) dosing.

Methods: LATTE-2 is a phase IIb, multicenter, parallel arm, open-label study in antiretroviral therapy–naive adults with HIV. After a 20-week Induction Period on oral CAB+abacavir/lamivudine, participants (pts) with plasma HIV-1 RNA< 50c/mL were randomized 2:2:1 to IM CAB LA+RPV LA Q8W, Q4W, or continue oral (PO) regimen in the Maintenance Period (MP). After W96, pts on IM regimens continued their current MP regimen. Pts randomized to PO in MP chose a Q8W or Q4W IM regimen in the Extension Period (EP). W256 analysis of MP & EP included virologic success with HIV-1 RNA< 50 c/mL (Food & Drug Administration Snapshot analysis), protocol-defined virologic failure (PDVF), & safety (intention-to-treat–Maintenance Exposed population).

Results: At W256, 88% (101/115; Q8W) & 74% (85/115; Q4W) of randomized IM pts had HIV-1 RNA< 50 c/mL, as did 93% (41/44) of PO to IM pts. No pt developed PDVF after W48. In the randomized IM arm (MP & EP), excluding injection-site reactions (ISRs), nasopharyngitis (45%), diarrhea (28%), & headache (24%) were the most common adverse events (AEs), with 34% (39/115; Q8W) & 33% (38/115; Q4W) of pts reporting AEs ≥grade 3, of which 12% (14/115; Q8W) & 11% (13/115; Q4W) were drug related. 3% (3/115; Q8W) & 17% (20/115; Q4W) of pts had AEs leading to withdrawal. 22% (25/115; Q8W) & 23% (27/115; Q4W) reported serious AEs (3 were drug related). In the PO to IM arm (EP only), most common AEs excluding ISRs were nasopharyngitis (25%), influenza (23%), & back pain (18%). 23% (10/44) reported AEs ≥grade 3 & 5% (2/44) had AEs leading to withdrawal. Majority of ISRs were mild/moderate pain & discomfort. < 1% of ISRs were severe, with 5 pts discontinuing due to ISRs.Table 1

Table 2

Conclusion: CAB+RPV LA injectable therapy, administered Q8W or Q4W, demonstrated high rates of virologic response & tolerability through 5 years. W256 results add to previous results & demonstrate long-term durability of CAB+RPV LA for people living with HIV.