Key result
A response-tailored course of sofosbuvir/daclatasvir was noninferior to a fixed 12-week course for achieving SVR12 in non-cirrhotic HCV genotype-4 patients (difference -1.67%; 95% CI -9.8 to +5.9).
Why the study?
Does a response-tailored duration of sofosbuvir/daclatasvir achieve non-inferior SVR12 compared to a fixed 12-week course in non-cirrhotic patients with chronic HCV genotype-4?
Population
120 non-cirrhotic Egyptian patients with chronic hepatitis C genotype-4 infection
Comparison
Response-tailored duration of sofosbuvir 400 mg… vs Fixed 12-week course of sofosbuvir 400 mg and…
Design
RCT, 1:1, open-label
Follow-up
12 weeks after end of treatment
Authors
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Supports tailored shorter sofosbuvir/daclatasvir in non-cirrhotic HCV-4; confirms non-inferiority to fixed 12-week therapy.
RCT (n=120)
Open-label
1:1
Yes
Does a response-tailored duration of sofosbuvir/daclatasvir achieve non-inferior SVR12 compared to a fixed 12-week course in non-cirrhotic patients with chronic HCV genotype-4?
Effect estimate: Difference -1.67% (95% CI -9.8 to +5.9)
Absolute Event Rate: 98.33% vs 96.67%
A response-tailored 8-to-12 week course of sofosbuvir/daclatasvir is non-inferior to a fixed 12-week course for achieving SVR12 in non-cirrhotic HCV genotype-4 patients.
Yakoot et al. (2017) conducted an RCT in Chronic Hepatitis C Genotype-4 Infection (n=120). Response-tailored duration of sofosbuvir/daclatasvir vs. Fixed 12 weeks duration of sofosbuvir/daclatasvir was evaluated on Proportions of patients achieving SVR12 (HCV RNA below lower level of quantification at week 12 after end of treatment) (Difference -1.67%, 95% CI -9.8 to +5.9). A response-tailored course of sofosbuvir/daclatasvir was noninferior to a fixed 12-week course for achieving SVR12 in non-cirrhotic HCV genotype-4 patients (difference -1.67%; 95% CI -9.8 to +5.9).
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