Sofosbuvir Adverse Events Profile in a Subset of Pakistani Population

To determine frequency and pattern of adverse events reporting in a subset of Pakistani population being treated for chronic hepatitis C with sofosbuvir combination therapy.

Descriptive study.

Department of Medicine, Gastroenterology Division, Shalamar Hospital, Lahore, from September 2015 to May 2016.

Patients who were offered sofosbuvir therapy for treatment of chronic hepatitis C were randomly enrolled. The study subset included both treatment nave as well as retreatment groups. Patients were screened for subjective as well as objective evidence of adverse events at regular intervals. Frequency was determined.

Among 196 patients with chronic hepatitis C, 192 patients received dual therapy consisting of ribavirin and sofosbuvir. The most frequent complaints in these subjects were fatigue, fever, myalgias and nausea accounting for 55%, 42%, 44.2% and 50%, respectively. Twenty-seven percent of patients reported with drop in hemoglobin of >2g/dl, while absolute neutropenia and moderate to severe thrombocytopenia was observed in 3% and 5% of patients, respectively. One patient died as a result of severe pancytopenia. Later derangements were all observed in patients with decompensated disease.

Sofosbuvir showed less severe adverse effects in terms of symptomatology and less frequent neutropenia and thrombocytopenia as compared to previous regimens. Careful monitoring is required, especially in those with decompensated liver disease.