盐酸可洛派韦联合索磷布韦治疗慢性丙型肝炎的真实世界研究OA

Objective To evaluate the efficacy and safety of a 12-week regimen of coblopasvir hydrochloride capsules combined with sofosbuvir tablets in patients with chronic hepatitis C(CHC).Methods CHC patients who visited our hospital and received a 12-week regimen of coblopasvir hydrochloride capsules combined with sofosbuvir tablets were enrolled as the study subjects.All patients received oral coblopasvir hydrochloride capsules(60 mg)and sofosbuvir tablets(400 mg)once daily for 12 weeks.Some patients with genotype 3b additionally received ribavirin tablets for 12 weeks at a dose of 1 000 mg·d-1 for those weighing＜75 kg and 1 200 mg·d-1 for those weighing≥75 kg.Hepatitis C virus(HCV)ribonucleic acid and relevant laboratory indicators were measured before and after treatment.The sustained virological response at 12 weeks post-treatment(SVR12)rate was observed in all patients.Changes in liver and renal function before and after treatment were compared,and safety was evaluated.Results A total of 110 CHC patients were enrolled.After treatment,97.27％(107 cases/110 cases)of patients achieved SVR12.Specifically,the SVR12 rate was 93.33％(14 cases/15 cases)in patients with decompensated cirrhosis,92.86％(13 cases/14 cases)in patients with genotype 3b CHC,87.50％(7 cases/8 cases)in patients with moderate-to-severe renal impairment,and 83.33％(5 cases/6 cases)in genotype 3b patients receiving ribavirin combination therapy.The alanine aminotransferase levels before and after treatment were 58.70(31.85,100.45)and 20.60(13.30,31.33)U·L-1,respectively;the aspartate aminotransferase levels were 52.75(28.68,82.13)and 23.30(17.78,33.73)U·L-1,respectively;the total bilirubin levels were 13.90(9.60,20.25)and 11.70(8.78,18.85)μmol·L-1,respectively;the albumin levels were 42.80(38.10,45.30)and 45.10(42.13,46.73)g·L-1,respectively.After treatment,the aforementioned indicators showed statistically significant differences compared to before treatment(P＜0.05,P＜0.001).The estimated glomerular filtration rates before and after treatment were 102.09(87.66,108.68)and 99.23(84.00,104.28)mL·min-1,respectively,with no statistically significant difference(P＞0.05).The main adverse drug reactions were fatigue(6.36％),decreased appetite(4.55％),abdominal distension(1.82％)and abdominal pain(1.82％).The overall incidence of adverse drug reactions was 10.91％(12 cases/110 cases),and the incidence in patients with decompensated cirrhosis was 13.33％(2 cases/15 cases).No serious adverse drug reaction occurred.Conclusion The 12-week regimen of coblopasvir hydrochloride capsules combined with sofosbuvir tablets demonstrated favorable efficacy and high safety in real-world CHC patients,including those with genotype 3b,decompensated cirrhosis,or moderate-to-severe renal impairment.