Efficacy and Safety of Sofosbuvir and Velpatasvir Combination for the Treatment of Chronic Hepatitis C in Patients With or Without Cirrhosis

Abstract

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 patient...

Treatment with Sofosbuvir/Velpatasvir of the most difficult to cure HCV-infected population

“…The impact of male sex on the odds of response to DAA therapies, including the SOF/VEL option, has been evaluated in numerous RWE analyses supporting our findings. 11, [40][41][42] Finally, the list of factors that reduce the chances of successful SOF/VEL therapy established in the current study is closed by a failure of previous treatment. Adding it to the combination of previously-described negative predictors lowered the cure rate to 67%.…”

Effectiveness of Sofosbuvir and Velpatasvir Combination in Chronic Hapatitis C

“…Results of our study was comparable to the studies conducted in past. [23,24] Comorbidities were hypertension found in 37 (55.2%) cases, diabetes in 15 (22.4%), ischemic heart disease in 10 (14.9%) cases and 5 (7.5%) patients. [21][22][23][24] Our research demonstrated sofosbuvir and velpatasvir to be extremely efficient against chronic HCV in 94.03%.…”

“…[23,24] Comorbidities were hypertension found in 37 (55.2%) cases, diabetes in 15 (22.4%), ischemic heart disease in 10 (14.9%) cases and 5 (7.5%) patients. [21][22][23][24] Our research demonstrated sofosbuvir and velpatasvir to be extremely efficient against chronic HCV in 94.03%. In a study by Wong et al in Asia, individuals with chronic hepatitis C had a 99.5% SVR rate with sofosbuvir and velpatasvir with or without ribavirin.…”

Combine treatment of Sofosbuvir and Velpatasvir in Patients of Chronic Hapatitis C

“…Findings of current research showed comparable outcomes to the previous studies. [18,19] Efficacy of sofosbuvir and velpatasvir with or without ribavirin in patients with chronic hepatitis C was investigated at 99.5 percent by Wong et al in Asia, but only 88 percent by patients with decompensated cirrhosis, according to the research. SVR patterns were found to be comparable to those seen in our research [20].…”