Treatment with sofosbuvir plus daclatasvir with or without ribavirin in patients with genotype 2 chronic hepatitis C virus (HCV) infection was associated with lower rates of sustained virologic response in the real-life setting, according to the results of a study published in the Journal of Viral Hepatitis.

In clinical trials of patients infected with genotype 2 HCV, treatment with sofosbuvir plus daclatasvir with or without ribavirin has demonstrated high efficacy and an acceptable safety profile. However, to address a lack of real-world data on this treatment regimen, investigators assessed information from patients in an ongoing national, multicenter, prospective, observational study (HEPATHER, Clinicaltrials.gov Identifier: NCT01953458).

Patients in the cohort who initiated treatment with sofosbuvir (400 mg/d) plus daclatasvir with or without ribavirin (1-1.2 g/d) were included and divided into 2 treatment groups based on treatment duration of 12 weeks and 24 weeks.

Sustained virologic response following 12 and 24 weeks of treatment was achieved in 88% and 91% of patients, respectively, with sofosbuvir plus daclatasvir with or without ribavirin. Common adverse events included asthenia (29%), fatigue (20%), and headache (15%), and the addition of ribavirin was associated with a higher rate of adverse events and treatment discontinuation.


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The investigators noted that small sample sizes, the uneven distribution of patients who were treatment naive, and the number of patients who had cirrhosis likely limit the ability to draw conclusions regarding the impact of treatment and duration on virologic response. However, study strengths include the fact that reported response rates in the study were similar to those seen in the clinic. Also, the patient distribution was representative of the real-life setting, improving the robustness and consistency of the study results.

According to the investigators, this is the first study showing the safety and efficacy of sofosbuvir plus daclatasvir with or without ribavirin for the treatment of patients with genotype 2 HCV in a real-world setting. They concluded that “this combination is suboptimal and shows that the addition of DCV demonstrates no significant difference to SVR rates.” However, they also acknowledge that this is a first-line, inexpensive generic combination that is frequently used in low-income countries.

Reference

Lédinghen V, Lusivika-Nzinga C, Bronowicki JP, et al; on behalf of The AFEF/ANRS Study Group. Sofosbuvir-daclatasvir is suboptimal in patients with genotype 2 chronic hepatitis C infection: real-life experience from the HEPATHER ANRS CO22 cohort [published online May 21, 2020]. J Viral Hepat. doi:10.1111/jvh.13321