| Treatment profile of hepatitis C patients - a comparison of interferon alpha 2a and 2b treatment regimes. | |
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MedLine Citation:
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PMID: 20810048 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: 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. STUDY DESIGN: Randomized Control Clinical Trial (RCCT). PLACE AND DURATION OF STUDY: The study was conducted at Sarwar Zuberi Liver Centre (SZLC), Civil Hospital Karachi (CHK), from May 2004 to July 2009. METHODOLOGY: Patients positive for qualitative HCV ribonucleic acid (RNA) by Polymerase chain reaction (PCR) 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) and 1200 mg/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. RESULTS: 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%). CONCLUSION: 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). |
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Authors:
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Sina Aziz; Rana Qamar; Iftikhar Ahmed; Khalid Imran; Muhammad Masroor; Jamila Rajper; Saba Nafay; Wajeeha Noorulain; Masood Hameed Khan |
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Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Journal of the College of Physicians and Surgeons--Pakistan : JCPSP Volume: 20 ISSN: 1022-386X ISO Abbreviation: J Coll Physicians Surg Pak Publication Date: 2010 Sep |
Date Detail:
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Created Date: 2010-09-02 Completed Date: 2010-11-02 Revised Date: 2012-02-15 |
Medline Journal Info:
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Nlm Unique ID: 9606447 Medline TA: J Coll Physicians Surg Pak Country: Pakistan |
Other Details:
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Languages: eng Pagination: 581-5 Citation Subset: IM |
Affiliation:
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Sarwar Zuberi Liver Centre, Civil Hospital/Dow University of Health Sciences, Karachi. sigma_98@hotmail.com |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Antiviral Agents / therapeutic use* Child Female Hepatitis C, Chronic / drug therapy*, virology Humans Interferon-alpha / adverse effects, therapeutic use* Male Middle Aged Recombinant Proteins Single-Blind Method Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Antiviral Agents; 0/Interferon-alpha; 0/Recombinant Proteins; 76543-88-9/interferon alfa-2a; 99210-65-8/interferon alfa-2b |
| Comments/Corrections | |
Comment In:
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J Coll Physicians Surg Pak. 2012 Jan;22(1):70-1; author reply 71
[PMID:
22237201
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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