Treatment of hepatitis C in hemodialysis patients with pegylated interferon alpha-2a as monotherapy.
BACKGROUND
The high prevalence of hepatitis C virus (HCV) infection in hemodialysis patients is of great concern because they have a higher rate of mortality than HCV-negative hemodialysis patients. The aim of the study was to evaluate the efficacy and safety of pegylated interferon alpha-2a monotherapy in hemodialysis patients with chronic HCV infection.


METHODS
Fourteen dialysis patients with chronic HCV infection were scheduled to receive 135 mug pegylated interferon alpha-2a subcutaneously, once a week, after dialysis session for a period of 48 weeks. Efficacy and safety were assessed by end of treatment viral response, sustained viral response, biochemical response, and adverse events. Serum HCV RNA levels were assessed using reverse transcriptase polymerase chain reaction (RT-PCR), while HCV genotype was analyzed by RT-PCR followed by hybridization of amplified products.


RESULTS
Of the 14 patients enrolled in the study, 9 completed treatment. Eight patients (57%) had undetectable levels of HCV RNA at the end of treatment, while one patient remained positive. Two (14.3%) patients were discontinued because of insufficient therapeutic response. Three patients (21.34%) did not finish treatment because serious adverse events occurred: one patient with bronchopneumonia and one with pericarditis were discontinued from treatment, while one patient died due to cerebral hemorrhage. Sustained viral response was present in 36% of the patients (5/8 patients) at the end of the follow up period. Biochemical response with normalization of serum ALT levels during treatment was observed in all treated patients (83 +/- 20.1 U/L at baseline vs. 23.4 +/- 4.6 U/L at week 48). The most common adverse events were flu-like syndrome, myalgia, arthralgia, and pancytopenia. Most of the adverse events were manageable. The serious adverse events were believed to be unrelated to the therapy, but rather to the co-morbidities of the hemodialysis patients.


CONCLUSIONS
Pegylated interferon alpha-2a treatment was effective in a considerable proportion of the treated hemodialysis patients with hepatitis C, and it was reasonably safe to use.
Sikole
Aleksandar
A
Department of Nephrology, University Clinical Centre, Skopje, R. Macedonia. asikole@hotmail.com
Dzekova
Pavlina
P
Selja
Nexhmi
N
Gaseva
Magdalena
M
Nikolov
Igor G
IG
Zabzun
Mustafa
M
Muharemi
Sheriat
S
Asani
Arben
A
Amitov
Vili
V
Mena
Sami
S
Grunevska
Violeta
V
Ivanovski
Ljubomir
L
Polenakovic
Momir
M
D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins; D006435:Renal Dialysis
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a