LATTE-2第48周数据.ppt

Most common ISR events overall were pain (67%), nodules (7%), and swelling (6%) The number of subjects reporting ISRs decreased over time, from 86% (Day 1) to 29% (Week 48)a 2/230 subjects (1%) withdrew as a result of ISRs (Q8W) Injection-Site Reactions—Maintenance Period Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. aRepresents percent of subjects with a Week 48 visit (n=215). Q8W IM (n=115) Q4W IM (n=115) IM subtotal (N=230) Number of injections 2126 3585 5711 Number of ISRs 1275 1568 2843 Grades Grade 1 1017 (80%) 1321 (84%) 2338 (82%) Grade 2 245 (19%) 234 (15%) 479 (17%) Grade 3 12 (1%) 10 (1%) 22 (1%) Grade 4 0 0 0 Duration, days ≤7 1135 (89%) 1414 (90%) 2549 (90%) Median 3.0 3.0 3.0 Day 1 Induction Outcomes (ITT-E) Margolis et al. AIDS 2016; Durban, South Africa. Abstract THAB0206LB. Day 1 Snapshot outcome Oral CAB(N=309) Virologic success 282 (91%) Virologic non-response 14 (5%) Data in window not 50 c/mL 9 (3%) Discontinued for lack of efficacy 2 (1%) Discontinued for other reason while not 50 c/mL 3 (1%) No virologic data in window 13 (4%) Discontinued due to AE or death 6 (2%) Discontinued for other reasons 7 (2%) Day 1 drug-related AEs Oral CAB (N=309) Preferred term ≥3% Nausea 27 (9%) Dyspepsia 9 (3%) Headache 9 (3%) Fatigue 8 (3%) ITT-E Snapshot 50 c/mL 91% Arthralgia Injection-site nodule Insomnia Influenza Injection-site erythema Anxiety Back pain Pyrexia Injection-site pruritus Injection-site pain Gastroenteritis Headache Syphilis Abdominal pain Upper respiratory tract infection Gonorrhoea Injection-site bruising Pharyngitis Injection-site induration Injection-site warmth Bronchitis Diarrhoea Nasopharyngitis Injection-site swelling Respiratory tract infection Anogenital warts Cough Fatigue Influenza-like illness Common On-Treatment Maintenance Period AEs (≥5% in Any Arm): Q8W vs Q4W Relative risk with 95% CI Favors Q8W Favors Q4W Percent Q4W IM (n=115) Q8W IM (n=115) 0 1