Background and aim For years,
interferon-based treatment has been offered to patients with
chronic hepatitis C virus (HCV)
infection; however, the complexity of the treatment, efficacy, and adverse effects were the primary concerns. All these concerns were addressed with the introduction of directly acting
antivirals (DAAs) to treat chronic HCV.
Sofosbuvir and
velpatasvir are second-generation DAAs used in combination for the treatment of chronic HCV
infection. The aim of our study was to determine and compare the efficacy and safety profile of the
sofosbuvir and
velpatasvir combination in treating patients with
chronic hepatitis C with or without
cirrhosis. Materials and methods This descriptive study was conducted at the Department of Medicine, Khyber Teaching Hospital, Peshawar, from March 15th to September 15th, 2021 after approval from the Institution Research and Ethical Review Board (IREB). Diagnosis of HCV was based on the detection of
hepatitis C ribonucleic acid (
RNA) fragments by reverse transcription-polymerase chain reaction (RT-PCR). Liver status was assessed with liver function tests and imaging.
Sofosbuvir (400 mg) and
velpatasvir (100 mg) were administered once daily for 12 weeks, followed by polymerase chain reaction (PCR) for HCV
RNA after 12 weeks of completion of treatment for determination of sustained virologic response at 12 weeks (SVR12). Patients with
cirrhosis also received weight-based
ribavirin. Adverse events experienced by the study participants during the course of treatment were recorded. Data were collected regarding patients' demographics, laboratory parameters, SVR12, and adverse events, and were then analyzed using SPSS, version 22 (IBM SPSS Statistics, Armonk, NY). Results A total of 58 patients with
cirrhosis and 58 patients without
cirrhosis with chronic HCV were enrolled. The rate of SVR12 in patients with
cirrhosis was 89.7% (52 patients achieved SVR12), compared to 98.3% in patients without
cirrhosis (57 patients achieved SVR12). Subgroup analysis of patients with
cirrhosis revealed that patients who have failed to achieve SVR12 were mostly males, had prolonged disease duration, and low
hemoglobin at baseline; however, the association of these factors with SVR12 was not significant. The incidence of adverse events among all study participants was 46.5%. Among the cirrhotic cohort, 37 (63.8%) patients experienced adverse events, while only 17 (29.3%) patients among the non-cirrhotic cohort had adverse events. A total of 24 patients with
cirrhosis (41.37%) reported mild complaints. The most commonly reported adverse event was gastrointestinal (GI) upsets (46.2%), followed by
fatigue (33.9%), while 19.9% developed miscellaneous adverse events such as
headaches,
rash, and
insomnia. Conclusion The combination of
sofosbuvir and
velpatasvir is highly effective and safe in patients with HCV with or without
cirrhosis. However, this combination's efficacy was slightly higher in non-cirrhotic patients (98.3%) than in cirrhotic patients (89.7%).