A double‐blind controlled trial of recombinant interferon‐α2b in haemodialysis patients with chronic hepatitis C virus infection and abnormal aminotransferase levels

Abstract

The efficacy and safety of recombinant interferon-alpha 2b (rIFN-alpha 2b) was evaluated in a double-blind controlled trial comprising 23 haemodialysis patients with antibodies to hepatitis C virus (anti-HCV), detectable serum HCV RNA by polymerase chain reaction and chronic alanine aminotransferase elevation. The patients were randomly assigned to receive rIFN-alpha 2b at a dose of 1.5 MU (increasing to 3 MU if no response was observed) (Group I: n = 14) or identical placebo (Group II: n = 9), for 6 months. A biochemical response (normal alanine aminotransferase) was observed in 10 patients (71.4%) from Group I and in one patient (11.1%) from Group II (P < 0.01) at the end of therapy, and in four patients from Group I (28.6%) and in none from Group II (NS) 12 months after therapy. Virological response (HCV RNA negative) was observed in four patients (28.6%) from Group I and in none from Group II (NS) at the end of therapy, and in two patients (14.2%) from Group I and in none from Group II (NS) 12 months after therapy. Interferon doses were 1.5 MU in 12 patients and 3 MU in two patients. Therapy interruption owing to severe side-effects was necessary in three patients (21.4%) from Group I and in two patients (22.2%) from Group II. Although long-term statistical differences were not observed, these results suggest that rIFN-alpha 2b at a low dose is a reasonable and well tolerated therapeutic approach for haemodialysis patients with chronic hepatitis C.

Meta‐analysis: interferon for the treatment of chronic hepatitis C in dialysis patients

“…In the majority of trials interferon was administered subcutaneously; in one study it was given by an intramuscular route. 44 Two (14.3%) studies were randomized clinical trials 41,48 while the others were prospective, cohort studies.…”

“…In other words, these studies may not be measuring the same underlying quantity from the same base population. The summary estimates may not Chan TM, et al [43] Campistol J.M, et al [48] Hanrotel C, et al [52] Espinosa M, et al [49] Huraib S, et al [51] Fernandez J.L, et al [41] Mean overall estimate Koenig P, et al [33] Izopet J, et al [42] Casanovas-Taltavull T, et al…”

“…Uchihara M, et al [44] Benci A, et al [45] Chan T.M, et al [43] Izopet J, et al [42] Campistol J.M, et al [48] Hanrotel C, et al [52] Espinosa M, et al [49] Fernandez J.L, et al [41] Huraib S, et al [51] Mean overall estimate Koenig P, et al [33] Casanovas-Taltavull T, et al [50] Raptopoulou-Gigi M, et al [39] Pol S, et al [38] Degos F, et al [53] Patients discontinued treatment (%) -10% 10% 20% 30% 40% 50% 60% 70% 80% 90% 0% be the best descriptive analysis, since they assume that all estimates from individual studies are from the same population. The sources of between study heterogeneity are unclear.…”

Interferon for Hepatitis C Virus in Hemodialysis—an Individual Patient Meta-analysis of Factors Associated with Sustained Virological Response

“…Limited data based on inclusion criteria were imputed for the remaining four studies (43)(44)(45)(46), but no further data were provided despite multiple attempts to contact authors.…”

The Evaluation of the Renal Transplant Candidates: Clinical Practice Guidelines

“…Several small trials have examined the safety and efficacy of interferon alpha-2a treatment of hemodialysis patients (566)(567)(568)(569)(570)(571)(572)(573)(574)(575). Two of the trials were randomized and controlled (569,574).…”