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Switch to DTG + RPV

Switch to DTG + RPV. Switch to DTG + RPV SWORD Study Switch to CAB LA + RPV LA IM LATTE-2 Study. SWORD-1 & 2 Studies : Switch to DTG + RPV. Design. Randomisation 1:1 Open-label. W48. W148. HIV+ ≥ 18 years On stable cART ≥ 6 months (2 NRTI + INSTI or PI/r or NNRTI)

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Switch to DTG + RPV

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  1. Switch to DTG + RPV • Switch to DTG + RPV • SWORDStudy • Switch to CAB LA + RPV LA IM • LATTE-2 Study

  2. SWORD-1 & 2 Studies: Switch to DTG + RPV • Design Randomisation 1:1 Open-label W48 W148 HIV+ ≥ 18 years On stable cART ≥ 6 months (2 NRTI + INSTI or PI/r or NNRTI) 1st or 2ndcART with no prior change for virologic failure HIV RNA < 50 c/mL ≥ 12 months HBs Ag negative N = 513 N = 511 • Endpoint • Primary: proportion of patients maintaining HIV RNA < 50 c/mL at W48 (ITT-exposed, snapshot) ; non-inferiority if lower margin of a two-sided 95% CI for the difference = - 8% for pooled studies (- 10% for each individual study) Llibre JM. Lancet. 2018 ; 391:839-49 SWORD

  3. SWORD-1 & 2 Studies: Switch to DTG + RPV Baseline characteristics and patient disposition Llibre JM. Lancet. 2018 ; 391:839-49 SWORD

  4. SWORD-1 & 2 Studies: Switch to DTG + RPV Virologic outcome at W48 (ITT-E, snapshot) Other virologic results at W48 DTG + RPV Continuation cART • HIV RNA < 50 c/mL (ITT-E snapshot) • SWORD-1 • 95% DTG + RPV • 96% continuation cART • Adjusted ≠: - 0.6% (95% CI: - 4.3 to + 3.0) • SWORD-2 • 94% DTG + RPV • 94% continuation cART • Adjusted ≠: 0.2% (95% CI: - 3.9 to + 4.2) • Confirmed virologic failure: HIV RNA ≥ 50 c/mL, retest ≥ 200 c/mL • DTG + RPV, N = 2 • Emergence of NNRTI resistance mutation (K101K/E) • Continued cART, N = 2 • No mutations % 94.9 94.7 100 80 60 40 20 4.7 3.9 0.6 1.2 0 Success HIV RNA < 50 c/mL Virologic non-response No virologic data Difference (95% CI)= - 0.2% (- 3.0 to 2.5) Llibre JM. Lancet. 2018 ; 391:839-49 SWORD

  5. 80 SWORD-1 & 2 Studies: Switch to DTG + RPV HIV RNA of subjectwith NNRTI-resistant mutation • 41-year-old female • Pre-cART HIV RNA > 2 millions c/mL ; 1stcART: TDF/FTC/EFV • Randomised to DTG + RPV • Documented non-adherence before W36 K101K/E on genotype (fold change RPV = 1.2) ; phenotype: sensitive to RPV HIV RNA, c/mL Screening D1 W4 W8 W12 W24 W36 W39 W45 Resuppressed on DTG + RPV Llibre JM. Lancet. 2018 ; 391:839-49 SWORD

  6. SWORD-1 & 2 Studies: Switch to DTG + RPV Adverse events, % * (some participants have more than 1 AE) ; anxiety (N = 4), depression (N = 3), insomnia (N = 2), depressed mood (N = 1), headache (N = 1), panic attack (N = 1), suicidal ideation (N = 1), tremor (N = 1), drug-induced liver injury (N = 1), eosinophilic pneumonia, acute (N = 1), abdominal distension (N = 2), dyspepsia (N = 2), peptic ulcer (N = 1), gastrointestinal haemorrhage (N = 1), pancreatitis, acute (N = 1), Hodgkin’s disease (N = 1), Kaposi sarcoma (N = 1), plasmablastic lymphoma (N = 1) Llibre JM. Lancet. 2018 ; 391:839-49 SWORD

  7. SWORD-1 & 2 Studies: Switch to DTG + RPV Fasting lipids at baseline and W48 DTG + RPV Continuation cART mg/dL Baseline Baseline 5 200 W48 W48 188.1 187.6 185.9 186 4 3.8 3.8 150 3.7 3.7 133.1 133.1 132.0 121.3 3 108.1 108.3 107.1 107.3 100 2 54.9 54.2 53.6 52.7 50 1 0 0 Totalcholesterol HDL cholesterol LDL cholesterol,calculated Triglycerides Total cholesterol:HDL ratio Llibre JM. Lancet. 2018 ; 391:839-49 SWORD

  8. SWORD-1 & 2 Studies: Switch to DTG + RPV • Conclusion • A switch to a novel, once-daily 2 drug-regimen of DTG + RPV demonstrated high efficacy and was non-inferior to the continuation of a combined antiretroviral therapy in virologically suppressed HIV-1–infected adults • The safety profiles of both DTG and RPV were consistent with their respective labels • Switching to DTG + RPV had a neutral effect on lipids, while significantly improving bone turnover biomarkers  Llibre JM. Lancet. 2018 ; 391:839-49 SWORD

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