HCV Response in Patients With End Stage Renal Disease Treated With Combination Pegylated Interferon α-2a and Ribavirin

Abstract

Goals To determine the efficacy and safety of combination therapy in patients with hepatitis C virus (HCV) and end-stage renal disease (ESRD). Background There is little data on the treatment of ESRD patients with pegylated interferon and ribavirin. We designed a pilot study to determine the initial and 12-week posttreatment viral response. Study A nonrandomized, prospective observational study of adjusted-dose combination therapy. Twenty patients were enrolled and began pegylated interferon at 135 μg/wk SC, and 4 weeks later ribavirin was started at 200 mg PO weekly, increasing gradually to 3 times a week for a total of 48 weeks. Results Twenty patients: M:F 18:2; mean age 52.4 years; genotype 1: 18, non-genotype 1: 2. Of the 20 patients, 5 withdrew before starting treatment. Of the 11 patients who reached 3 months, 6 had early virologic response, defined as at least a 2-log drop in their HCV count (54.5%). Of the 5 patients who were treated for 1-year, only 1 patient had a response 12 weeks after treatment. Side effects included 4 cases of anemia and 1 patient with headache. Conclusions The initial response rate in individuals taking 3 months of treatment in our study is comparable with studies in non-ESRD patients with no serious adverse side effects. However, the sustained posttreatment rate was low. This demonstrates that combination therapy is a safe therapeutic option in the ESRD population with HCV infection which needs further testing to determine if increasing the length of treatment and/or the dose of ribavirin will affect posttreatment rates.

Pegylated interferon monotherapy of chronic hepatitis C in dialysis patients: Meta‐analysis of clinical trials

“…Few studies have evaluated combined therapy in patients receiving maintenance dialysis and the quality of evidence is very low [Mousa et al, 2004;Bruchfeld et al, 2006;Rendina et al, 2007;Schmitz et al, 2007;Carriero et al, 2008;van Leusen et al, 2008;Hakim et al, 2009]. Nephrologists have been so far reluctant to use combined therapy in dialysis patients with HCV, and ribavirin therapy in this setting is not recommended.…”

Sustained Virologic Response with Triple Therapy in a Hemodialysis Patient with Chronic HCV Infection

“…The ribavirin dose was started as 200 mg/week and increased gradually (200 mg with two week interval). The SVR rate of this study was reported to be 6.7% [16] . In light of these studies, ribavirin dose was started as 200 mg/day in our patient.…”

Hepatitis C Virus and End Stage Renal Disease

“…A few small preliminary studies showed some initial success with combined interferon and ribavirin [59]. Recently, Hakim reported a disappointing 6.7% rate of SVR in 15 patients treated with PEG-interferon and low dose ribavirin (initial dosing 200 mg weekly starting at week 4, then escalating to 200 mg three times weekly) [60]. Fabrizi [61••] performed a meta-analysis of ten studies that included 151 patients treated with combined interferon (standard or PEG) and ribavirin therapy.…”