Abstract
Hepatitis C virus (HCV) infection is one of the primary causes of liver cirrhosis and hepatocellular carcinoma. In hemodialysis patients, the rate of HCV infection is high and is moreover associated with a poor prognosis. In liver transplantation patients with HCV infection, recurrent HCV infection is universal, and re-infected HCV causes rapid progression of liver fibrosis and graft loss. Additionally, in patients with HCV and human immunodeficiency virus (HIV) co-infection, liver fibrosis progresses rapidly. Thus, there is an acute need for prompt treatment of HCV infection in these special populations (i.e., hemodialysis, liver transplantation, HIV co-infection). However, until recently, the standard anti-HCV treatment involved the use of interferon-based therapy. In these special populations, interferon-based therapies could not achieve a high rate of sustained viral response and moreover were associated with a higher rate of adverse events. With the development of novel direct-acting antivirals (DAAs), the landscape of anti-HCV therapy for special populations has changed dramatically. Indeed, in special populations treated with interferon-free DAAs, the sustained viral response rate was above 90%, with a lower incidence and severity of adverse events.
Highlights
Worldwide, it is estimated that 130–150 million people are currently infected with hepatitis C virus (HCV)
CT clinical trials, RW real-world data, IFN interferon, DAAs direct-acting antivirals, PTV paritaprevir, OBV ombitasvir, DSV dasabuvir, SOF sofosbuvir, RBV ribavirin, RTV ritonavir, Peg-IFN pegylated interferon, SMV simeprevir, DCV daclatasvir, ASV asunaprevir, eGFR estimated glomerular filtration rate, GT genotype, SVR sustained viral response, SAE serious adverse event, HD hemodialysis, CKD chronic kidney disease, DDI drug–drug interactions a All-treatment discontinuation due to unrelated adverse events (AEs) contraindicated in patients with severe renal dysfunction [46, 48]
In the same study, which enrolled 21 hemodialysis patients with Hepatitis C virus (HCV) GT1 infection, we reported the efficacy and safety of daclatasvir/asunaprevir combination therapy [65], with an overall SVR rate at 12 weeks (SVR12) rate of 95.5% (20/21)
Summary
It is estimated that 130–150 million people are currently infected with hepatitis C virus (HCV). One patient (4.8%) discontinued treatment due to AEs. Toyoda et al [66] reported the efficacy and safety of daclatasvir/asunaprevir combination therapy for HCV GT1b-infected dialysis patients (overall SVR12 rate, 100%; 28/28), and treatmentrelated AEs were similar to those noted among patients with normal renal function. 98% of patients (95% CI 89–100%; 49/50) achieved SVR12 and no patients discontinued the treatment due to AEs. In the phase 3 ION4 trial, 335 patients co-infected with HIV and HCV (75, 23, and 2% were GT1a, GT1b, and GT4, respectively; 20% had liver cirrhosis) receiving ART were treated with a 12-week sofosbuvir/ledipasvir regimen [36]. Author contributions GS conceived the topic of the review article, GS, KO, KM, and NS collected and reviewed articles, GS and NS wrote the manuscript and reviewed the final version, and GS collected the data and created the tables
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