Interferon as treatment for acute hepatitis C (original) (raw)
Related papers
Gut, 1996
Background-There is some controversy concerning the efficacy of low dose a interferon therapy in chronic hepatitis C. Aims-To evaluate the effectiveness of treatment with low doses ofa interferon in chronic hepatitis C. Patients-One hundred and forty one patients with anti-HCV positive chronic active hepatitis C from six hospitals were enrolled in the study. Methods-Patients were randomised to treatment with 5 MU (group A) or 1-5 MU (group B) injections. The dose was reduced in responders from group A or increased in non-responders from group B to maintain treatment with the miniimal effective dose. Patients were treated for 48 weeks and followed up for 24 additional weeks with no treatment. Normalisation of alanine aminotransferase (ALT) was used to evaluate response. Results-A sustained response was seen in eight patients from group A (12%) and in 15 (21%) from group B. This difference was not statistically significant. Increasing the dose of interferon led to sustained response in only five of 58 patients (90/o) from group B who did not respond to 1996 38: 603-609 Gut J M Sánchez-Tapias, X Forns, S Ampurdanés, et al. of a multicentre, randomised trial. Results effective in chronic active hepatitis C.
Interferon therapy for hepatitis C
Antiviral Research, 1994
Initial trials indicated that around 50% of patients respond to recombinant alpha interferon by normalizing alanine aminotransferase (ALT) at the end of therapy and that half of these relapsed within 6 months following cessation of treatment. Both dose and duration of treatment are critical in the response to therapy. Higher doses and longer duration have been suggested to be more effective than the current recommendations of 3 MUI thrice weekly for 6 months based on results of these initial studies which used ALT and histological scores to evaluate the efficacy of interferon therapy. Following studies using virological markers have shown that improvments in clinical features of disease are associated with decrease or loss of hepatitis C virus (HCV) from serum and liver. The heterogeneity of the response rates between clinical centers using identical protocole emphasizes that the selection of the patients treated was as important for the outcome than the therapy regimen itself with better responses in cases without cirrhosis and with low levels of HCV RNA. Furthermore, the genotype of HCV seems to be also critical for the response rate. Virological evaluations appears therefore crucial to assess not only HCV infection but also for the indication and monitoring of therapy.
Treatment of acute hepatitis C with interferon alpha 2b prevents chronicity
Gut, 1999
Background In people who are infected with the hepatitis C virus (HCV), chronic infection often develops and is difficult to eradicate. We sought to determine whether treatment during the acute phase could prevent the development of chronic infection. Methods Between 1998 and 2001, we identified 44 patients throughout Germany who had acute hepatitis C. Patients received 5 million U of interferon alfa-2b subcutaneously daily for 4 weeks and then three times per week for another 20 weeks. Serum HCV RNA levels were measured before and during therapy and 24 weeks after the end of therapy. Results The mean age of the 44 patients was 36 years; 25 were women. Nine became infected with HCV through intravenous drug use, 14 through a needle-stick injury, 7 through medical procedures, and 10 through sexual contact; the mode of infection could not be determined in 4. The average time from infection to the first signs or symptoms of hepatitis was 54 days, and the average time from infection until the start of therapy was 89 days. At the end of both therapy and follow-up, 43 patients (98 percent) had undetectable levels of HCV RNA in serum and normal serum alanine aminotransferase levels. Levels of HCV RNA became undetectable after an average of 3.2 weeks of treatment. Therapy was well tolerated in all but one patient, who stopped therapy after 12 weeks because of side effects. Conclusions Treatment of acute hepatitis C with interferon alfa-2b prevents chronic infection. (N Engl
Interferon-α for chronic hepatitis C: An analysis of pretreatment clinical predictors of response
Hepatology, 1994
To identify predictors-of short-term and sustained ALT normalization after interferon treatment in adult patients with chronic hepatitis C, we performed a metanalysis of individual patients' data, with construction and cross-validation of a prediction rule, in 361 patients from two randomized trials. In one trial, 116 subjects with transfusion-related chronic hepatitis C were treated with lymphoblastoid interferon (6 MU/m2 three times a week for 2 mo, then 3 MU/m2 three times a week for 4 or 10 mo). In the other study, 245 patients with community-acquired chronic hepatitis C received recombinant interferon-%, (10 MU three times a week for 2 mo, then 5 MU three times a week for 4 mo; then random allocation of subjects with
Hepatology, 1996
AND THE HEPATITIS INTERVENTIONAL THERAPY GROUP* with continued therapy at that dose; however, a propor-To evaluate response rates to 3, 5, or 10 million units tion of patients who do not respond to 12 weeks of treat-(MU) of interferon alfa-2b, given thrice weekly, and to ment with 3 or 5 MU may respond to higher doses. Aldetermine whether higher doses of interferon increase though the long-term sustained response rates are the likelihood or durability of the response, a multicenmarginally increased with interferon doses above 3 MU ter, randomized trial was performed at nine academic three times per week, the side effects are difficult to medical centers in the United States. Two hundred forty tolerate. The analysis of baseline factors in relation to eight patients with chronic hepatitis C were randomized response identified no single baseline factor associated to receive 3, 5, or 10 MU of interferon alfa-2b thrice with a low-enough response rate to warrant withholding weekly for 12 weeks. Based on the alanine aminotransinterferon therapy from patients with chronic hepatitis ferase (ALT) response at treatment-week 12, the patients C. (HEPATOLOGY 1996;24:1034-1040.) were rerandomized to additional therapy at the same or at increased doses for an additional 12 to 36 weeks; in the case of no response to the highest dose, the patients Recombinant interferon (IFN) has been shown to be effecwere discontinued from the study. Serum ALT concentive in decreasing serum alanine aminotransferase (ALT) levtrations and liver histology were measured. The overall els, 1-6 in eliminating detectable hepatitis C virus ribonucleic complete response rates to 3, 5, or 10 MU were not differacid (HCV RNA), 7 and in reducing histologic evidence of heent at treatment-week 12 (31% vs. 42% vs. 40%, not signifipatic inflammation in patients with chronic hepatitis C. 1,6 cant). The majority of week-12 responders continued to After nearly a decade of research, however, two major probrespond during additional treatment. When the treatlems with treatment remain. First, a response by the end of ment was discontinued, 15.4% to 19.0% of patients maintreatment occurs in fewer than half of patients. In our previtained their response. Of the nonresponders to 3 MU at ous study, the normalization of the serum ALT levels was week 12, who were continued on 3 MU for an additional seen in 38% of patients treated with a dose of 3 million units 12 weeks, none responded. However, response to addi-(MU) of interferon alfa-2b three times per week for 24 weeks, 1 tional therapy occurred in 12% of week-12 nonrespondand all responding patients achieved their response by treaters, whose dose was escalated from 3 or 5 MU to 10 MU. ment weeks 8 to 12 of treatment. 8 Similar response rates have The only baseline features associated with the treatment now been obtained from several other randomized controlled response were the absence of fibrosis or cirrhosis on studies. 2-6 Second, a response to IFN is usually not mainthe pretreatment liver biopsy and viral genotype. We tained after the drug is stopped, and 50% to 70% of patients conclude that the initial response to interferon in parelapse with the elevation of the serum ALT and HCV RNA tients with chronic hepatitis C is not increased by treatlevels. 1,6 Thus, the ability to achieve and sustain a long-term ment with higher doses of the drug. Patients who do not response to IFN in these patients is only 13% to 25%, with respond to 3 MU by treatment-week 12 will not respond the currently recommended dose regimens. 6 Whether higher initial doses of IFN or the escalation of the dose in nonresponders improves the response to treatment remains contro-Abbreviations: MU, million units; ALT, alanine aminotransferase; IFN, interferon; HCV versial.
Long-term follow-up after successful interferon therapy of acute hepatitis C
Hepatology, 2004
Early treatment of acute hepatitis C infection with interferon alfa-2b (IFN-␣-2b) prevents chronicity in almost all patients. So far, no data are available on the long-term outcome after interferon (IFN) therapy of acute hepatitis C. The aim of this study was to assess the clinical, virological, and immunological long-term outcome of 31 successfully treated patients with acute hepatitis C infection who were followed for a median of 135 weeks (52-224 weeks) after end of therapy. None of the individuals had clinical evidence of liver disease. Alanine aminotransferase (ALT) levels were normal in all but 1 patient. Serum hepatitis C virus (HCV) RNA was negative throughout follow-up, even when investigated with the highly sensitive transcription-mediated amplification (TMA) assay (cutoff 5-10 IU/mL). In addi-
Journal of the College of Physicians and Surgeons Pakistan Jcpsp, 2010
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).
Response to different conventional interferons in treatment of chronic hepatitis C
Journal of Ayub Medical College, Abbottabad : JAMC
Sustained virological response to interferon therapy is a great challenge for patients of chronic Hepatitis C. Over 20 brands of interferons are available in the local market with each claiming over 80% response and a wide variation in the cost thus creating confusion for treating physicians as to which drug should be selected. Chronic Hepatitis C patients attending outpatients department of Pakistan Medical Research Centre JPMC from January 1998-December 2010 were evaluated. Complete blood count, liver function tests, serum proteins, HCV-RNA were done in all cases before starting therapy. Side effects were also noted. Total of 851 cases received interferon 3 MIU three times a week for 6 months. There were 638 (75%) males and 213 (25%) females, mean age was 36.1 +/- 10.4 years. All were HCV-RNA positive prior to treatment, at the end of 6 months 666 (78.3%) became negative while 185 (21.7%) were non-responders with positive HCV RNA. End of treatment response (ETR) showed 84.7% with ...
Alimentary Pharmacology and Therapeutics, 2004
Aim: To evaluate the efficacy of early interferon a-2b in non-post-transfusion acute hepatitis C virus: a prospective study with historical comparison. Patients: Group A: 28 patients prospectively treated for acute hepatitis C virus with daily regimen of interferon 5 million units for 2 months. Group B: historical series of 16 patients with untreated acute hepatitis C virus. Results: There was no significant difference between the two groups with regard to gender, age, icterus, alanine aminotransferase, or genotypes. In group B, hepatitis spontaneously resolved in three of 16 (19%) patients (follow-up 1-7 years). In group A, 21 of 25 patients became sustained viral responders (75%; P ¼ 0.0003 vs. group B). Factors include not predictive of sustained viral response: age, gender, sources of infection, presence of icterus, alanine aminotransferase peak, bilirubin peak, incubation period, presence of hepatitis C virus antibodies at presentation, or genotypes. The time from presentation to the start of therapy was, however, significantly shorter in sustained viral responders (43 ± 31 days) than in relapsers or non-responders (88 ± 52 days) (P ¼ 0.016). Conclusions: Early treatment of acute hepatitis C virus with interferon prevents chronicity. A short waiting time from presentation to treatment appears as the most relevant predictive factor for sustained response.