Study evaluates safety and efficacy of glecaprevir/pibrentasvir in chronic hepatitis C adults

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Created On: 07/11/2020

Study evaluates safety and efficacy of glecaprevir/pibrentasvir in chronic hepatitis C adults

A multicenter, phase III, open-label (EXPEDITION-3) study was conducted to explore the safety and efficacy of glecaprevir/pibrentasvir therapy in treatment-naïve Brazilian adults having hepatitis C infection genotype 1-6.

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Key take away

In treatment-naive adults suffering from hepatitis C infection with compensated liver cirrhosis (F4) or without liver cirrhosis (F2 or F3), glecaprevir/pibrentasvir was found to be well-tolerated and demonstrated high efficacy.

Background

Method

Participants without cirrhosis and with compensated cirrhosis were recruited in this study and were administered eight or 12 weeks of glecaprevir/pibrentasvir therapy respectively. Among the 100 patients enrolled, 75 received 8 weeks’ treatment, and 25 received 12 weeks’ treatment.

The rate of sustained virologic response after treatment was the primary outcome parameter and the on-treatment virologic failure and decline rates were the secondary outcome parameters. The baseline polymorphisms were precisely evaluated in nonstructural viral protein 5A (NS5A) and nonstructural viral protein 3 (NS3). Lab abnormalities and noxious events were also examined.

Result

The sustained virologic response at week 12 after the treatment was high (98/100 [98%]), as shown below:

Data are n (%) unless stated otherwise. ^†2-sided 95% CI based on the Wilson score method. CI, confidence interval; ITT, intention-to-treat; mITT, modified ITT; N/A, not applicable; OTVF, ontreatment virologic failure; SVR12, sustained virologic response at post-treatment Week 12

It remained elevated despite host factors and baseline viral factors including hepatitis C virus RNA levels, demographics, polymorphisms in NS3 and/or NS5A, genotype, and comorbidities.

Only 55% of patients were found to report ≥1 adverse event (the most common being headache [18%]). No serious adverse effect was found to be related to the drug. There were no hepatic decompensations reported.

Conclusion

Glecaprevir/pibrentasvir is a well-tolerated and efficient therapy in treatment-naïve Brazilian patients who are suffering from hepatitis C infection with compensated cirrhosis and without cirrhosis.