Fig. 1
Design of the ENABLE trials* and timing of the SF-36v2 and CLDQ-HCV (HRQoL) assessments. *Each study included an open-label initiation phase, with patients receiving eltrombopag 25–100 mg for up to 9 weeks, with dose escalations being guided by platelet response. Patients whose platelet counts increased to a prespecified threshold to initiate AVT (ENABLE-1, 90 × 109/L; ENABLE-2, 100 × 109/L) were randomized 2:1 to receive either the same dose of eltrombopag they had received during the initiation phase or matching placebo. Hepatocellular carcinoma and portal vein thrombosis were assessed between screening and baseline and every 6 months thereafter through Doppler ultrasound of the abdomen. During the AVT phase, patients in ENABLE-1 were administered PEG-2a at 180 μg/week with RBV at 800 mg/day if they were infected with genotypes 2/3. If they were infected with genotypes other than 2/3, RBV doses were determined by body weight, with patients weighing <75 kg being given 1000 mg/day and patients weighing ≥75 kg being given 1200 mg/day. The weekly PEG-2b dose in ENABLE-2 was 1.5 μg/kg, while RBV doses were 800 mg/day, 1000 mg/day, 1200 mg/day, or 1400 mg/day based on body weights of ≤65 kg, 65–80 kg, 81–105 kg, or >105 kg, respectively. †Twenty-four weeks for genotypes 2/3 and 48 weeks for other genotypes of hepatitis C virus. ‡PEG-2a in ENABLE-1 and PEG-2b in ENABLE-2. AVT, antiviral therapy; CLDQ-HCV, Chronic Liver Disease Questionnaire–Hepatitis C Virus version; HRQoL, health-related quality of life; PEG, pegylated interferon; RBV, ribavirin; SF-36v2, Short-Form 36 Health Survey version 2; SVR, sustained virologic response