638. Safety, Efficacy, and Durability of Long-Acting CAB and RPV as Maintenance Therapy for HIV-1 Infection: LATTE-2 Week 256 Results
Bibliographic record
Abstract
Abstract 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. Disclosures Keith Henry, MD, 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) Daniel Podzamczer, MD, PhD, 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) Mar Masiá, MD, PhD, 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) Hans Jaeger, MD, 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) Marie-Aude Khuong-Josses, MD, Viiv HC (Advisor or Review Panel member) Kenneth Sutton, MA, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Cynthia C. McCoig, MD, ViiV Healthcare (Employee) Kati Vandermeulen, MSC, Janssen Pharmaceutica (Employee, Shareholder) Rodica Van Solingen-Ristea, MD, Janssen R&D (Employee) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".