Randomized trial of pegylated interferon α-2b monotherapy in haemodialysis patients with chronic hepatitis C

Mark W. Russo, Reem Ghalib, Samuel H. Sigal, Viren Joshi

Research output: Contribution to journalArticle

78 Citations (Scopus)

Abstract

Background. Chronic hepatitis C infection is prevalent among haemodialysis patients. The goal of our study was to determine the efficacy and safety of pegylated interferon α-2b in haemodialysis patients with chronic hepatitis C. Methods. We conducted a trial which randomized haemodialysis patients with chronic hepatitis C to 1.0 or 0.5 μ/kg of pegylated interferon α-2b subcutaneously, weekly for up to 48 weeks. End-points were sustained viral response and adverse events. Data were analysed as intention to treat and as intended per protocol. Results. After 16 patients were enrolled, the study was terminated because of adverse events and modifications needed in the study design. Nine subjects were randomized to the 1.0 μ/kg group and seven subjects were randomized to the 0.5 μ/kg group. Serious adverse events requiring discontinuation of therapy occurred in five (56%) subjects in the 1.0 μ/kg group and in two (28%) subjects in the 0.5 μ/kg group (P = 0.36). The most common adverse events were hypertension and infection unrelated to neutropenia. Two (22%) subjects in the 1.0 μ/kg group, both genotype 1, had a sustained viral response, and none of the subjects in the 0.5 μ/kg group had a sustained viral response (P = 0.47). Five subjects in the 1.0 μ/kg group were able to complete 24 weeks or longer of therapy as per protocol and two (40%) were sustained responders. Conclusions. In our study group, pegylated interferon α-2b was poorly tolerated and was associated with substantial side effects. Sustained response rates seen with pegylated interferon in our study do not appear to be better than rates reported for standard interferon α-2b.

Original languageEnglish (US)
Pages (from-to)437-443
Number of pages7
JournalNephrology Dialysis Transplantation
Volume21
Issue number2
DOIs
StatePublished - Feb 2006
Externally publishedYes

Fingerprint

Chronic Hepatitis C
Interferons
Renal Dialysis
Infection
Neutropenia
Genotype
Hypertension
Safety
Therapeutics

Keywords

  • Kidney
  • Renal
  • Treatment
  • Viral

ASJC Scopus subject areas

  • Nephrology
  • Transplantation

Cite this

Randomized trial of pegylated interferon α-2b monotherapy in haemodialysis patients with chronic hepatitis C. / Russo, Mark W.; Ghalib, Reem; Sigal, Samuel H.; Joshi, Viren.

In: Nephrology Dialysis Transplantation, Vol. 21, No. 2, 02.2006, p. 437-443.

Research output: Contribution to journalArticle

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abstract = "Background. Chronic hepatitis C infection is prevalent among haemodialysis patients. The goal of our study was to determine the efficacy and safety of pegylated interferon α-2b in haemodialysis patients with chronic hepatitis C. Methods. We conducted a trial which randomized haemodialysis patients with chronic hepatitis C to 1.0 or 0.5 μ/kg of pegylated interferon α-2b subcutaneously, weekly for up to 48 weeks. End-points were sustained viral response and adverse events. Data were analysed as intention to treat and as intended per protocol. Results. After 16 patients were enrolled, the study was terminated because of adverse events and modifications needed in the study design. Nine subjects were randomized to the 1.0 μ/kg group and seven subjects were randomized to the 0.5 μ/kg group. Serious adverse events requiring discontinuation of therapy occurred in five (56{\%}) subjects in the 1.0 μ/kg group and in two (28{\%}) subjects in the 0.5 μ/kg group (P = 0.36). The most common adverse events were hypertension and infection unrelated to neutropenia. Two (22{\%}) subjects in the 1.0 μ/kg group, both genotype 1, had a sustained viral response, and none of the subjects in the 0.5 μ/kg group had a sustained viral response (P = 0.47). Five subjects in the 1.0 μ/kg group were able to complete 24 weeks or longer of therapy as per protocol and two (40{\%}) were sustained responders. Conclusions. In our study group, pegylated interferon α-2b was poorly tolerated and was associated with substantial side effects. Sustained response rates seen with pegylated interferon in our study do not appear to be better than rates reported for standard interferon α-2b.",
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AB - Background. Chronic hepatitis C infection is prevalent among haemodialysis patients. The goal of our study was to determine the efficacy and safety of pegylated interferon α-2b in haemodialysis patients with chronic hepatitis C. Methods. We conducted a trial which randomized haemodialysis patients with chronic hepatitis C to 1.0 or 0.5 μ/kg of pegylated interferon α-2b subcutaneously, weekly for up to 48 weeks. End-points were sustained viral response and adverse events. Data were analysed as intention to treat and as intended per protocol. Results. After 16 patients were enrolled, the study was terminated because of adverse events and modifications needed in the study design. Nine subjects were randomized to the 1.0 μ/kg group and seven subjects were randomized to the 0.5 μ/kg group. Serious adverse events requiring discontinuation of therapy occurred in five (56%) subjects in the 1.0 μ/kg group and in two (28%) subjects in the 0.5 μ/kg group (P = 0.36). The most common adverse events were hypertension and infection unrelated to neutropenia. Two (22%) subjects in the 1.0 μ/kg group, both genotype 1, had a sustained viral response, and none of the subjects in the 0.5 μ/kg group had a sustained viral response (P = 0.47). Five subjects in the 1.0 μ/kg group were able to complete 24 weeks or longer of therapy as per protocol and two (40%) were sustained responders. Conclusions. In our study group, pegylated interferon α-2b was poorly tolerated and was associated with substantial side effects. Sustained response rates seen with pegylated interferon in our study do not appear to be better than rates reported for standard interferon α-2b.

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