Treatment profile of hepatitis C patients - a comparison of interferon alpha 2a and 2b treatment regimes

To compare the side effects, cost, end treatment response [ETR] and Sustained viral response [SVR] with combination therapy of either interferon alpha 2a or 2b in combination with Ribavarin. Randomized Control Clinical Trial [RCCT]. The study was conducted at Sarwar Zuberi Liver Centre [SZLC], Civil Hospital Karachi [CHK], from May 2004 to July 2009. Patients positive for qualitative HCV ribonucleic acid [RNA] by Polymerase chain reaction [PCA] and genotype 3 were included. Patients with decompensated cirrhosis, severe depressive illness, autoimmune hepatitis, hyperthyroidism, pregnancy, heart failure, uncontrolled diabetes, obstructive pulmonary disease, children less than three years and patients who had previously received treatment were excluded. Single blind randomization using computerized randomization list was done and patients divided into groups A and B, those requiring treatment were given injection Interferon 3 million units [MU] subcutaneously [SC] three times/week and Ribavarin 1000 mg per day [weight 75kg] orally with either interferon alpha 2a [group A; FDA approved products] or alpha 2b [group B; non FDA approved product]. Demographics, side effects, ETR and SVR were noted. ETR was defined as absence of virus at the end of treatment and SVR was taken as absence of HCV RNA at 6 months after completion of treatment. There were a total 310 patients with mean age of 34.07 +/- 9.38 years including 52.4% males, [n=162]. Majority of the patients were from North Pakistan. There were 155 patients each in group A and group B respectively. The cost of treatment for interferon alpha for a single patient for 6 months was Rs 60,000, while for Interferon alpha 2b was Rs 30,000. Side effects [fever initially, followed by fatigue, headache, musculoskeletal pain, depression, alopecia, insomnia, and anorexia] were more prominent in group B when compared with group A. In group A, ETR was 83.8% [130/155] while in group B was 83.2% [129/155]. While SVR available in group A was 61/70 [87.1%] and in group B was 60/72 [83.3%]. Response to combination therapy for HCV was 83%. ETR and SVR were similar for both interferon alpha 2a and 2b. Side effects though minor are more with alpha 2b [non FDA approved products]

Clinical efficacy and safety of the combination therapy of peginterferon alpha and ribavirin in cirrhotic patients with HCV infection / 대한간학회지

BACKGROUND/AIMS: The combination therapy of peginterferon (PEG-IFN) and ribavirin is the standard treatment for hepatitis C virus (HCV) infection. However, few trials have involved patients with cirrhosis. The purpose of this study was to elucidate the efficacy and safety of treatment with PEG-IFN and ribavirin in patients with cirrhosis associated with HCV infection. METHOD: A total of 65 patients were treated with PEG-IFN alpha-2a/ribavirin (n=32) or PEG-IFN alpha-2b/ribavirin (n=33). PEG-IFN alpha-2a and PEG-IFN alpha-2b were administered at doses of 180 microg/week and 1.5 microg/kg/week, respectively, and ribavirin was administered orally at doses of 800-200 mg. Patients with HCV genotype 1 and genotype non-1 were treated for 48 and 24 weeks, respectively. The treatment response was assessed based on the sustained virologic response (SVR). RESULTS: The early virologic response (EVR), end-of-treatment response (ETR), and SVR were 70.0%, 52.0%, and 24.0%, respectively, in genotype 1 (n=50). In genotype non-1 (n=15), the ETR was 53.3% and the SVR was 33.3%. The overall SVR did not differ with genotype (1 vs non-1, 24.0% vs. 33.3%; P=0.471) or between decompensated cirrhosis and compensated cirrhosis (20.0% vs. 27.3%, P=0.630). Ten patients developed cirrhotic complications during the treatment, and 11 stopped treatment due to treatment-related adverse events. CONCLUSION: The combination therapy of PEG-IFN and ribavirin exhibited a low efficacy in cirrhotic patients with HCV infection and was associated with frequent serious complications. However, with careful management of complications, the therapy may have a considerable efficacy in some patients with cirrhosis and HCV infection.

A Case of Vasculitis in Chronic Hepatitis C Patient Treated with Pegylated Interferon Alpha-2a and Ribavirin / 대한간학회지

There has been an increase in the number of patients treated with pegylated interferon (PEG-IFN) and ribavirin due to the better antiviral efficacy. The main serious adverse events of PEG-IFN plus ribavirin combination therapy are bone marrow suppression and hemolytic anemia. However, there are few reports of vasculitis occurring during PEG-IFN therapy. We describe a patient who developed vasculitis during the treatment of chronic hepatitis C with PEG-IFN and ribavirin.

A Case of Bell's Palsy Associated with Peginterferon Alfa-2a and Ribavirin Therapy for Chronic Hepatitis C Virus Infection / 대한간학회지

Pegylated interferon alfa-2a (PEG-IFN) and ribavirin combination therapy is the first line treatment for chronic HCV infection. There are four reports of Bell's palsy associated with interferon-alpha (IFN-alpha) and ribavirin therapy. We report here a case of Bell's palsy that occurred in a patient with chronic HCV infection during combination PEG-IFN and ribavirin therapy. The patient was 49-year-old man with chronic hepatitis C for 2 years. The liver biopsy showed grade 1 and stage 1. Therapy with PEG-IFN (Pegasys) 180 microgram/week and ribavirin 1200 mg/day was initiated. After 3 weeks of treatment, the patient showed a loss of muscular tone on the left side of his face. A diagnosis of Bell's palsy was made, and the PEG-IFN and ribavirin therapy was stopped. Prednisolone 45 mg/d was given and then tapered for 8 weeks. His palsy improved over 6 weeks.

Rheumatoid arthritis probably induced by pegylated interferon in a patient with chronic hepatitis C.

We report a 47-year-old woman who developed features of rheumatoid arthritis 20 weeks after initiation of treatment with pegylated interferon and ribavirin for chronic hepatitis C. She continued to have symptoms six months after discontinuation of the drugs which she received for 24 weeks with rival clearance.