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The treatment did not improve sustained virologic response but did increase the rate of treatment-related adverse events.
In new data presented during the Digestive Disease Week (DDW) 2022 Meeting in San Diego, investigators find that ribavirin is not a suitable option for patients with genotype 3 hepatitis C virus (HCV) and compensated cirrhosis.
A team, led by Wen Xin Flora Xu, National University of Singapore, evaluated the efficacy and safety of sofosbuvir/velpatasvir with or without ribavirin in genotype 3 compensated patients with cirrhosis.
The current guidelines for genotype 3 HCV care for patients with compensated cirrhosisthat were treated with 12 weeks of Sofosbuvir/Velpatasvir call for the use of ribavirin for unless baseline resistant-associated substitution mutations were excluded.
However, this testing is not yet widely available and the clinical differentiation between compensated cirrhosis from advanced fibrosis is challenging in the primary care setting.
“A safe and simplified regimen is crucial for global hepatitis C Virus (HCV) elimination,” the authors wrote.
The investigators suggest balancing the risk of treatment-related adverse events and the need for closer monitoring in adding ribavirin to a sofosbuvir/velpatasvir regimen.
In the systematic review and analysis, the investigators identified studies from inception to June 2021 involving HCV genotype 3 compensated patients with cirrhosis treated with sofosbuvir/velpatasvir with and without ribavirin.
The team sought secondary outcomes of treatment-related adverse events, defined by symptomatic anemia requiring transfusion or a drop in hemoglobin beyond 2 g/dL.
Overall, the final analysis included 7 studies involving 1088 patients.
Sustained virologic response at 12 weeks was similar in both intention-to-treat (RR, 1.03; 95%CI, 0.99-1.07; I2 = 0%) and per-protocol analysis (RR, 1.03; 95%CI, 0.99-1.07; I2 = 48%) of patients treated with sofosbuvir/velpatasvir.
The overall pooled rate of treatment-related adverse events was 7.2%.
In addition, ribavirin use increased the overall pooled risk of treatment-related adverse events (RR, 4.20; 95%CI, 1.29-13.68; I2 = 0%). In the subgroup analysis, the investigators found ribavirin wax related to an increased sustained virologic response at weeks in patients with baseline resistant-associated substation mutation, but it did not significantly increase the sustained virologic response at 12 weeks among treatment-experienced patients.
“In GT3 compensated cirrhosis patients treated with 12 weeks of SOF/VEL, RBV was associated with higher adverse events without significant improvement in SVR12,” the authors wrote. “Our findings suggest routine RBV is not mandatory for GT3 compensated cirrhosis patients treated with SOF/VEL.”
The study, “EP1198: EFFICACY AND SAFETY OF ADDING RIBAVIRIN FOR GENOTYPE 3 HCV COMPENSATED CIRRHOSIS RECEIVING 12-WEEKS OF SOFOSBUVIR/VELPATASVIR: A META-ANALYSIS,” was published online by DDW 2022.