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Effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir for hepatitis C virus in clinical practice: A
Maya Leventer-Roberts1,2, Ariel Hammerman3, Ilan Brufman1
1Clalit Research Institute, Tel Aviv, Israel.
Background:
Direct acting antivirals for hepatitis C virus have shown dramatic results in clinical trials. However, their effectiveness has yet to be demonstrated within observational cohorts which lack exclusion criteria found in randomized control trials.
Aim:
To determine the effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir in achieving sustained virological response.
Methods:
Retrospective observational cohort study of all Clalit Health Services members with hepatitis C virus genotype 1 who were dispensed dasabuvir/ombitasvir/paritaprevir/ritonavir from January 1, 2015 to-November 31, 2015.
Results:
There were 564 participants during the study period. The average age was 61.9 years, 52.0% were male, and 61.5% were born Eastern/Central Europe or Central Asia. The prevalence of diabetes was 31.7% and 70.3% were overweight/obese. Cirrhosis was present in 41.0% of participants, of whom 52.8% had stage 4 fibrosis. Of the cohort, 416 (74.8%) had follow-up viral load testing at 10 or more weeks after the end of treatment. We report a sustained virological response of 98.8% among those tested.
Conclusions:
Treatment with dasabuvir/ombitasvir/paritaprevir/ritonavir demonstrated a near universal effectiveness in achieving a sustained virological response among HCV patients in a large cohort.
Insights
Direct acting antivirals, specifically dasabuvir/ombitasvir/paritaprevir/ritonavir, show high effectiveness for hepatitis C virus (HCV) treatment. This real-world study confirms near-universal sustained virological response in a large patient cohort.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Direct-acting antivirals (DAAs) have revolutionized hepatitis C virus (HCV) treatment.
- Randomized controlled trials (RCTs) demonstrate high efficacy, but real-world data from observational cohorts are crucial.
- Observational studies are needed to validate DAA effectiveness in patient populations with diverse characteristics and fewer exclusion criteria.
Purpose of the Study:
- To evaluate the real-world effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir in achieving sustained virological response (SVR) in HCV genotype 1 patients.
- To assess treatment outcomes in a large, unselected patient cohort treated in a routine clinical setting.
Main Methods:
- Retrospective observational cohort study design.
- Inclusion of all Clalit Health Services members diagnosed with HCV genotype 1 treated with dasabuvir/ombitasvir/paritaprevir/ritonavir between January 1, 2015, and November 31, 2015.
- Analysis of sustained virological response based on viral load testing 10 or more weeks post-treatment.
Main Results:
- A cohort of 564 participants was analyzed, with a mean age of 61.9 years.
- The cohort exhibited significant comorbidities, including 31.7% with diabetes and 70.3% overweight/obese.
- Cirrhosis was present in 41.0% of participants, with 52.8% having stage 4 fibrosis.
- Among the 416 participants (74.8%) with follow-up viral load testing, a sustained virological response rate of 98.8% was achieved.
Conclusions:
- Dasabuvir/ombitasvir/paritaprevir/ritonavir treatment is highly effective in achieving SVR in a large, real-world HCV patient cohort.
- The findings support the use of this DAA regimen in diverse patient populations, including those with comorbidities and advanced liver disease.
- Real-world effectiveness closely mirrors the high efficacy observed in clinical trials.
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