Efficacy and safety of sofosbuvir/velpatasvir in a real‐world chronic hepatitis C genotype 3 cohort

Abstract

Background and Aim Real‐world data on sofosbuvir/velpatasvir with and without ribavirin (SOF/VEL ± RBV), particularly among patients with genotype 3 (GT3) decompensated cirrhosis, prior treatment, coinfection, and hepatocellular carcinoma (HCC), are scarce. We aimed to assess the efficacy and safety of SOF/VEL ± RBV in a real‐world setting that included both community and incarcerated GT3 hepatitis C virus (HCV) patients. Methods We included all GT3 HCV patients treated with SOF/VEL ± RBV in our institution. The primary outcome measure was the overall sustained virological response 12 weeks after treatment (SVR12), reported in both intention‐to‐treat (ITT) and per‐protocol analyses. The secondary outcome measures were SVR12 stratified by the presence of decompensated cirrhosis, prior treatment, HCC, and HIV/hepatitis C virus coinfection and the occurrence rate of serious adverse events requiring treatment cessation or hospitalization. Results A total of 779 HCV patients were treated with 12 weeks of SOF/VEL ± RBV, of which 85% were treated during incarceration. Among the 530 GT3 HCV patients, 31% had liver cirrhosis, and 6% were treatment‐experienced. The overall SVR12 for GT3 was 98.7% (95% confidence interval: 97.3%, 99.5%) and 99.2% (95% confidence interval: 98.1%, 99.8%) in ITT and per‐protocol analyses, respectively. High SVR12 was also seen in ITT analysis among GT3 HCV patients with decompensated cirrhosis (88%), prior treatment (100%), HCC (100%), and HIV/hepatitis B virus coinfection (100%). Apart from one patient who developed myositis, no other serious adverse events were observed. Conclusion The SOF/VEL ± RBV is a safe and efficacious treatment option for GT3 HCV patients in a real‐world setting. SOF/VEL with RBV may be considered for decompensated GT3 HCV patients.

Orally delivered MK-4482 inhibits SARS-CoV-2 replication in the Syrian hamster model

“…The incorporation of ribonucleosides has also been shown to be highly selective for RNA compared to host DNA 33 . For example, the guanosine ribonucleoside analog, ribavirin, which has several mechanisms of action including one of RNA mutation/error catastrophe, has been used in the past in patients, including children with severe lower respiratory tract infections and is still used in combination for the treatment of hepatitis C 34,35 . If deemed safe, MK-4482 would join GS-5734 as the second broadly direct acting antiviral to target emerging RNA viruses, and in this case, specifically SARS-CoV-2.…”

The impact of unrestricted access to direct-acting antiviral among incarcerated hepatitis C virus-infected patients

“…CGH is the main public hospital to provide medical care for the incarcerated population in Singapore. All HCV patients treated were prospectively included in a treatment database since 2013, as described in our previous study [ 25 ]. Our health service research officer conducted an additional comprehensive search on all HCV patients using pharmacy prescription database in order to ensure all HCV patients treated were included.…”

“…Patients were monitored in a dedicated clinic following international guidelines [ 26 , 27 ]. Liver cirrhosis was defined based on histological, radiological and clinical findings, which included liver stiffness measurement (LSM) ≥12kPa [ 25 ]. In subjects without clinical or radiological evidence of liver cirrhosis, non-invasive assessment of fibrosis stage was performed using fibrosis-4 index (Fib-4) and transient elastography (Fibroscan; Echosens, Paris, France), followed by liver biopsy in patients with discordant non-invasive fibrosis assessment [ 27 ].…”

“…The options of DAA among incarcerated GT1 HCV patients included ombitasvir/paritaprevir/ritonavir, SOF/ ledipasvir or SOF/VEL for 12 weeks. Ribavirin was added for HCV patients who with liver cirrhosis, prior treatment, clinically significant portal hypertension or stable hepatocellular carcinoma, as per physician’s discretion [ 25 ].…”

Long-term albumin infusion in decompensated cirrhosis: A review of current literature

“…Besides, only 3.2% (14/431) of patients with hepatitis C related cirrhosis received direct-acting antiviral therapy in the ANSWER study. As the treatment with direct-acting viral therapy is expected to improve the clinical outcomes in these patients[ 73 , 74 ], whether this specific subset of decompensated patients would benefit from long-term albumin infusion following sustained virological response remains unanswered.…”