RESUMEN
Objective:To compare the clinical efficacy and safety of ledipasvir/sofosbuvir (LDV/SOF) and elbasvir/grazoprevir (EBR/GZR) in treatment of patients with chronic hepatitis C (CHC).Methods:The clinical data of 143 patients with genotype 1b CHC treated in Huzhou Central Hospital from January 2020 to December 2021 were retrospectively analyzed, including 74 cases treated with LDV/SOF and 69 cases treated with EBR/GZR. The virological response after 4 and 12 weeks of treatment and 12wk after drug withdrawal was determined; and the serological and liver inflammation indexes before and after treatment in two groups were compared. SPSS 25.0 software was used for statistical analysis of the data.Results:The virological response rates of the LDV/SOF group and EBR/GZR group were 97.30% and 98.55%, 98.65% and 100.00%, 97.30% and 98.55% after 4 and 12 weeks of treatment and 12 weeks after the end of treatment, respectively (all P > 0.05). At the end of treatment, the liver inflammation indexes ALT, AST and GGT in the two groups were significantly lower than the baseline levels ( Z=-7.470 and -6.974, -9.757 and -6.832, -3.578 and -4.054, P<0.01). Adverse reactions in both groups were mild, and no serious adverse events occurred. Conclusion:Both LDV/SOF and EBR/GZR have good clinical efficacy in the treatment of genotype 1b CHC patients. And the patients are well tolerated.
RESUMEN
OBJECTIVE：To evalua te the economics of glecaprevir/pibrentasvir （G/P）versus elbasvir/grazoprevir （EBR/GZR） in chronic hepatitis C genotype 1b（GT1b）treatment-naive patients without cirrhosis ，and to provide evidence support for medical and health decision-making. METHODS ：Under assuming the bid price of G/P and EBR/GZR therapy schemes before medical insurance negotiation was adopted （scenario 1）and assuming that the price of EBR/GZR was reduced by 85％ and the price of G/P was reduced by 80％（scenario 2），Markov model was developed to simulate the lifetime cost and health outcomes progress of 10 000 untreated chronic hepatitis C GT 1b treatment-naive patients without cirrhosis and calculate incremental cost-effectiveness ratio（ICER）. Single factor sensitivity analysis and probability sensitivity analysis were conducted to verify the results. The highest price（price reduction ratio ）of G/P scheme was analyzed with cost-effectiveness advantage ，when other parametes kept stable under scenario 2. RESULTS ：Under 2 kinds of scenarios ，compared with EBR/GZR scheme ，G/P scheme had higher cost （scenario 1：68 800 yuan vs. 62 338 yuan；scenario 2：13 760 yuan vs. 11 490 yuan）and healty utility （scenario 1：14.97 QALY vs. 14.90 QALY；scenario 2：14.97 QALY vs. 14.90 QALY），and ICER value of G/P was lower than willingness-to-pay threshold （scenario 1：92 314 yuan/QALY；scenario 2：32 428 yuan/QALY）. The change of most parameters in single factor sensitivity analysis didn ’t influence the results of base-case analysis ，and the findings from the base-case analysis were confirmed by probability sensitivity analyses. The price of G/P scheme needed to be reduced by at least 62％ to realize cost-effective advantage. CONCLUSIONS ： Under the set price scenario ，G/P scheme has cost-effectiveness advantages than EBR/GZR scheme in chronic hepatitis C GT 1b treatment-naive patients without cirrhosis.