Clinical efficacy of intramuscular human interferon‐β<i>vs</i> interferon‐α2b for the treatment of chronic hepatitis C

Pérez, Ramón; Pravia, R.; Artímez, M L; Giganto, Froilán; Rodrı́guez, Manuel; Lombrana, J. L. Sanchez; Rodrigo, Luı́s

doi:10.1111/j.1365-2893.1995.tb00014.x

Cited by 22 publications

(7 citation statements)

References 7 publications

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“…Frosi et al [38] compared IFNα and IFNβ in 20 naïve patients treated for 6 months and did not observe any significant differences between the two treatment groups in terms of the frequency of adverse events. In another study [39] , flu-like syndromes and hair loss were less frequent in the IFNβ group (16% and 16%, respectively) compared to the IFNα group (86% and 57%, respectively), the frequency of other adverse events were similar between the two groups. Cecere et al [40] evaluated the efficacy and tolerability of the following types of IFN in 150 patients: lymphoblastoid IFNα, leukocytic IFNα and natural IFNβ.…”

Section: Clinical Studies Comparing the Safety Of Ifnβ To Ifnαmentioning

confidence: 99%

“…Several studies comparing the safety of IFNβ and IFNα have been performed [29,30,[38][39][40][41][42] . Frosi et al [38] compared IFNα and IFNβ in 20 naïve patients treated for 6 months and did not observe any significant differences between the two treatment groups in terms of the frequency of adverse events.…”

Section: Clinical Studies Comparing the Safety Of Ifnβ To Ifnαmentioning

confidence: 99%

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Safety of interferon β treatment for chronic HCV hepatitis

Festi¹,

Sandri²,

Mazzella³

et al. 2004

WJG

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Hepatitis C is a major cause of liver-related morbidity and mortality worldwide. In fact, chronic hepatitis C is considered as one of the primary causes of chronic liver disease, cirrhosis and hepatocellular carcinoma, and is the most common reason for liver transplantation. The primary objectives for the treatment of HCV-related chronic hepatitis is to eradicate infection and prevent progression of the disease. The treatment has evolved from the use of α-interferon (IFNα) alone to the combination of IFNα plus ribavirin, with a significant improvement in the overall efficacy, and to the newer PEG-IFNs which have further increased the virological response, used either alone or in combination with ribavirin. Despite these positive results, in terms of efficacy, concerns are related to the safety and adverse events. Many patients must reduce the dose of PEG-IFN or ribavirin, others must stop the treatment and a variable percentage of subjects are not suitable owing to intolerance toward drugs. IFNβ represents a potential therapeutic alternative for the treatment of chronic viral hepatitis and in some countries it plays an important role in therapeutic protocols. Aim of the present paper was to review available data on the safety of IFNβ treatment in HCV-related chronic hepatitis.The rates of treatment discontinuation and/or dose modification due to the appearance of severe side effects during IFNβ are generally low and in several clinical studies no requirements for treatment discontinuation and/or dose modifications have been reported. The most frequent side effects experienced during IFNβ treatment are flu-like syndromes, fever, fatigue and injection-site reactions. No differences in terms of side-effect frequency and severity between responders and non-responders have been reported. A more recent study, performed to compare IFNβ alone or in combination with ribavirin, confirmed the good safety profile of both treatments. Similar trends of adverse event frequency have been observed in subpopulations such as patients with genotype-1b HCV hepatitis unresponsive to IFNα treatment or with HCV-related cirrhosis and patients with acute viral hepatitis. If further studies will confirm the efficacy of combined IFNβ and ribavirin treatment, this regimen could represent a safe and alternative therapeutic option in selected patients.Festi D, Sandri L, Mazzella G, Roda E, Sacco T, Staniscia T, Capodicasa S, Vestito A, Colecchia A. Safety of interferon β treatment for chronic HCV hepatitis.

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Section: Clinical Studies Comparing the Safety Of Ifnβ To Ifnαmentioning

confidence: 99%

Section: Clinical Studies Comparing the Safety Of Ifnβ To Ifnαmentioning

confidence: 99%

Safety of interferon β treatment for chronic HCV hepatitis

Festi¹,

Sandri²,

Mazzella³

et al. 2004

WJG

View full text Add to dashboard Cite

show abstract

“…To our knowledge, no information is available in the literature regarding the rate of sustained response in previous nonresponders to interferon‐ α after a more prolonged administration of interferon‐ β . Once the efficacy of interferon‐ β is confirmed, combination treatment of ribavirin and interferon‐ β or pegylated interferon‐ β will probably have higher efficacy than interferon‐ β monotherapy among patients with chronic hepatitis C. Administration of intravenous interferon‐ β for long periods is clinically impractical, and intramuscular administration of the drug at a dosage of 3–6 MIU gave unsatisfactory results because of insufficient bioavailability compared with interferon‐ α [20].…”

Section: Introductionmentioning

confidence: 99%

Racial differences in responses to interferon‐β‐1a in chronic hepatitis C unresponsive to interferon‐α: a better response in Chinese patients

Cheng

Marcellin

Bacon

et al. 2004

Journal of Viral Hepatitis

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Re-treatment with interferon-alpha alone for chronic hepatitis C nonresponders to interferon-alpha monotherapy is almost ineffective. This multicentre, randomized, parallel-group, dose-finding study evaluated the efficacy of interferon-beta-1a in the treatment of chronic hepatitis C patients unresponsive to interferon-alpha. A total of 267 patients were randomized to one of four groups: subcutaneous interferon-beta-1a 12 MIU (44 microg) or 24 MIU (88 microg) administered three times weekly or daily. Patients were treated for 48 weeks and then followed up for an additional 24 weeks. There was a trend towards a dose-response relationship regarding virological [loss of detectable serum hepatitis C virus (HCV) RNA] and biochemical response (normalization of serum alanine aminotransferase). Overall, 22 patients (8.3%) had a virological response at the end of treatment; nine patients (3.4%) had a sustained virological response (SVR). Strikingly, 21.7% (5/23) of Chinese patients achieved SVR. Univariate analysis revealed that race was the only variable related to SVR [odds ratio (OR) 16.6; 95% CI 4.1-67.3; P < 0.0001]. Multiple logistic regression analysis also confirmed that more Chinese patients achieved SVR than non-Chinese patients (OR 12.3; 95% CI 2.6-59.3; P = 0.0017). In addition, complete clearance of HCV-RNA occurred earlier in Chinese than in non-Chinese responders (median 2 vs 30 weeks; P = 0.020). Thirty-six patients were withdrawn from treatment because of adverse events. Most adverse events were mild or moderate in severity. In conclusion, interferon-beta-1a provided considerable clinical benefit in Chinese patients with chronic hepatitis C unresponsive to interferon-alpha. The evaluation of interferon-beta-1a in this setting is progressing.

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“…The virological response was poorer in the IFN-β group. 25 Another report looked into the use natural IFN-β via subcutaneous injection. In this study, 6 MIU of natural IFN-β was given subcutaneously at 3 times a week for 6 months.…”

Section: Discussionmentioning

confidence: 99%

Recombinant Interferon-Beta-1a Plus Ribavirin for the Treatment of Chronic HCV Infection: A Prospective, Randomized, Comparative Pilot Study

et al. 2009

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Background/Aims: Interferon beta (IFN-β) has been shown to have antiviral activity, and thus could be useful in treating viral infections. Therefore, we compared the efficacy and safety of recombinant IFN-β (IFN-β-1a) plus oral ribavirin versus interferon alpha (IFN-α) plus ribavirin therapy for the treatment of chronic hepatitis C (HCV). Methods: Twenty treatment-naïve patients were randomized into two equal-sized treatment groups. Both IFN-β-1a (44μg) and IFN-α (3 MIU) were given subcutaneously three times a week, while ribavirin was given orally at 1,000-1,200 mg/day. Patients were treated for 24 weeks and followed for an additional 24 weeks. Results: After 24 weeks of treatment, six (60%) and four patients (40%) in the IFN-β-1a group and IFN-α groups, respectively, achieved viral clearance. The sustained virological response (SVR) at the end of the observation period was similar in both groups (40%). However, the baseline viral load was significantly higher (p=0.034) in the IFN-β-1a group than in the IFN-α group, and there were more HCV genotype 1 patients in the IFN-β-1a group (eight versus seven). The IFN-β-1a group was associated with similar adverse events in terms of frequency and severity. Conclusions: The SVR rate and safety profile were similar for the combination of IFN-β-1a and ribavirin and that of IFN-α and ribavirin.

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Clinical efficacy of intramuscular human interferon‐βvs interferon‐α2b for the treatment of chronic hepatitis C

Cited by 22 publications

References 7 publications

Safety of interferon β treatment for chronic HCV hepatitis

Safety of interferon β treatment for chronic HCV hepatitis

Racial differences in responses to interferon‐β‐1a in chronic hepatitis C unresponsive to interferon‐α: a better response in Chinese patients

Recombinant Interferon-Beta-1a Plus Ribavirin for the Treatment of Chronic HCV Infection: A Prospective, Randomized, Comparative Pilot Study

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