Switching PEG-RBV to DAAs in Patients Chronically Infected with GT1b HCV

 

　　In today’s Free Paper Session, Dr Guofeng Chen from Beijing 302 Hospital of PLA, China will present their results of Switching PEG-RBV to DAAs for Chinese with Chronic Hepatitis C GT1b.

 

　　Chronic hepatitis C is prevalent in China and the major genotype is 1b. Standard treatment is pegylated interferon plus RBV (PR). Beijing 302 Hospital of PLA and the Humanity & Health Medical Center (Hong Kong) jointly established the HCV Diagnosis and Treatment Center in 2013. New regimens have becoming increasingly available since 2013.

 

　　Some patients have used the PR therapy and have attained RVR or EVR, but they suffered and could not tolerant adverse reactions as well as the long duration of treatment. Dr Chen and her colleagues switched PR to DAAs to treat those patients who gave informed consent.

 

　　This clinical study was prospective, real-life research. 129 consecutive CHC GT1b Chinese patients who were initiated with PR and had completed early virologic response were studied. 20 (16%) discontinued PR therapy, due to PR-intolerance and were switched to 4 (n=10) or 8 (n=10) weeks of Harvoni?? (ledipasvir/sofosbuvir) at the patient’s discretion. The first aim was to identify the SVR of Chinese chronic hepatitis C patients treated with PR therapy after switching to a pan-oral direct-acting antiviral agents strategy. The second aim was to evaluate the safety and cost-effectiveness of a DAA strategy.

 

　　A simplified Markov model was used for decision analysis. It simulated the progression of a 50-year-old chronic hepatitis C, genotype 1b cohort, under different SOF-based therapeutic strategies. The initial population consisted of both treatment-na??ve and -experienced patients by sex and fibrosis stages (F0-F4 and decompensate cirrhosis defined by METAVIR score). Subjects can progress through fibrosis stages F0-F4, DC based on natural progression rates. Fibrosis regression after SVR is possible for subjects in stage F3 and F4. Further fibrosis progression to HCC and liver transplant after SVR is possible for subjects in stages F4 and DC at lower rates. An annual discount rate of 3% was applied.

 

　　The authors used real-world data from their centers to evaluate clinical effect and costs. Disease progression and QALYs data were taken from literature. A cycle of 4-weeks was applied in the first 52 weeks and yearly cycle was applied afterwards. Outcome measures include discounted cost (in 2014 US$), quality-adjusted-life-year (QALY), and incremental cost-effectiveness ratio (ICER).

 

　　The results shows that for PR therapy in CHC GT1b patients with cEVR, switching to 4-8 weeks Harvoni?? is safe, effective and cost-effective. All CHC patients treated with Harvoni?? had SVR12 as compared to 52/109 who continued PR therapy (100 % vs. 48%, P<0.0001). Compared to PR48, PR12+ 4 weeks Harvoni and PR12+ 8 weeks Harvoni gained 1.173 and 1.168 QALYs, PR12+ 4 weeks Harvoni?? have a cost saving.

 

　　The authors concluded that when CHC patients got EVR on PR treatment but were intolerant to the severe side effects, we can switch therapy to DAAs. They also noted the limitation of the small size of this study and the undefined equivalence between 4-week and 8-week treatments.

 

(From: Chen GF, Second Liver Cirrhosis Diagnosis and Treatment Center, 302 Hospital, Beijing, China)