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Explore the efficacy & safety of Sofosbuvir-Velpatasvir in Decompensated HCV Cirrhosis with participants who are treatment-naïve & experienced. Study features, results by genotype, MELD score changes, adverse events, and conclusions.
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Phase 3 TreatmentNaïve & Experienced Sofosbuvir-Velpatasvir in Decompensated HCV CirrhosisASTRAL-4 Curry MP, et al. N Engl J Med. 2015;373:2618-28.
Sofosbuvir-Velpatasvir in Decompensated HCV CirrhosisASTRAL-4: Study Features Source: Curry MP, et al. N Engl J Med. 2015;373:2618-28.
Sofosbuvir-Velpatasvir in Decompensated HCV CirrhosisASTRAL-4: Study Design 0 12 36 24 Week Treatment-naïve & experiencedGT 1, 2, 3, 4, 6 CTP Class B SOF-VEL N=90 SVR12 SOF-VEL + RBV SVR12 N=87 SOF-VEL SVR12 N=90 Abbreviations: SOF-VEL = sofosbuvir-velpatasvir; RBV = ribavirin Drug DosingSofosbuvir-velpatasvir (400/100 mg): fixed-dose combination; one pill once dailySofosbuvir: 400 mg once dailyRibavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Source: Curry MP, et al. N Engl J Med. 2015;373:2618-28.
Sofosbuvir-Velpatasvir in Decompensated HCV CirrhosisASTRAL-4: Participants Source: Curry MP, et al. N Engl J Med. 2015;373:2618-28.
Sofosbuvir-Velpatasvir in Decompensated HCV CirrhosisASTRAL-4: Participants Source: Curry MP, et al. N Engl J Med. 2015;373:2618-28.
Sofosbuvir-Velpatasvir in Decompensated HCV CirrhosisASTRAL-4: Results ASTRAL-4: SVR12 Results by Genotype 75/90 82/87 77/90 60/68 65/68 65/71 7/14 11/13 6/12 8/8 6/6 6/7 Source: Curry MP, et al. N Engl J Med. 2015;373:2618-28.
Sofosbuvir-Velpatasvir in Decompensated HCV CirrhosisASTRAL-4: Change in MELD Scores on Treatment 27% Worsened 52% Improved Baseline MELD <15 n=208 n= Change in MELD 84% Improved 8% Worsened Baseline MELD >15 n=26 n= Change in MELD Source: Curry MP, et al. N Engl J Med. 2015;373:2618-28.
Sofosbuvir-Velpatasvir in Decompensated HCV CirrhosisASTRAL-4: Adverse Events Source: Curry MP, et al. N Engl J Med. 2015;373:2618-28.
Sofosbuvir-Velpatasvir in Decompensated HCV CirrhosisASTRAL-4: Conclusions Source: Curry MP, et al. N Engl J Med. 2015;373:2618-28.