Ribavirin
Interferon therapy is currently considered the standard of care for the treatment of hepatitis C virus infection. This medication is FDA approved for up to 24 months treatment with a sustained response rate of less than 15%.
As you may know, many medications are often used for indications outside of FDA labeling including dosage and administration.
California law provides for such use if there are two or more peer review articles that support such use in terms of efficacy (for life threatening diseases: HCV is fatal in more that 20% of patients).
The following list of references supports the use of ribavirin with interferon for the treatment of hepatitis. FDA approval has taken place for patients who have relapsed after an initial course of treatment (Davis and McHutchison, NEJM 11/98) showing a 43-49% sustained response after 6 months of combination treatment [$7200 AWP]).
This is clearly superior to interferon therapy alone (monotherapy) and is comparable to Infergen at 15mcg TIW for 12 mo. for relapse patients. Data from Reichard, Schalm and unpublished information from the International Naive Trial of INF+/- Ribavirin have shown results of 40% sustained response of 6-12 months of treatment based on genotype and viral load [12 month if G-1 and viral load >1M].
Ribavirin is an oral medication dosed at 1gm per day 3x200AM and 2x200mg in PM if <75kg or 1.2 gm if >75kg. If combination therapy is used for 6 months, there is a remarkable decrease in physician and laboratory visits compared to 18 months of monotherapy with interferon. FDA approval is pending for Ribavirin and Interferon in combination for patients who have never undergone treatment.
Ribavirin References
1) National Institutes of Health Consensus Development Conference Panel statement: management of hepatitis C. Hepatology. 1997;26:2S-10S.
2) Acero D, Adrados M, Gonzalez-Huix F, Figa M. Ribavirin treatment in patients with chronic hepatitis C refractory to interferon-alpha. Gastroenterol.Hepatol. 1996;19:243-6.
3) Bizollon T, Palazzo U, Ducerf C, et al. Pilot study of the combination of interferon alfa and ribavirin as therapy of recurrent hepatitis C after liver transplantation. Hepatology. 1997;26:500-4.
4) Brillanti S, Garson J, Foli M, et al. A pilot study of combination therapy with ribavirin plus interferon alfa for interferon alfa-resistant chronic hepatitis C. Gastroenterology. 1994;107:812-7.
5) Davis GL, Esteban-Mur R, Rustgi VK, et al. Retreatment of relapse after interferon therapy for chronic hepatitis C: an international randomized controlled trial of interferon plus ribavirin vs interferon alone. Hepatology. 1997;26:a247-a247
6) Lai MY, Kao JH, Yang PM, et al. Long-term efficacy of ribavirin plus interferon alfa in the treatment of chronic hepatitis C. Gastroenterology. 1996;111:1307-12.
7) Reichard O, Andersson J, Schvarcz R, Weiland O. Ribavirin treatment for chronic hepatitis C. Lancet. 1991;337:1058-61.
8) Reichard O, Yun ZB, Sonnerborg A, Weiland O. Hepatitis C viral RNA titers in serum prior to, during, and after oral treatment with ribavirin for chronic hepatitis C. J.Med.Virol. 1993;41:99-102.
9) Reichard O, Schvarcz R, Weiland O. Therapy of hepatitis C: alpha interferon and ribavirin. Hepatology. 1997;26:108S-11S.
10) Reichard O, Norkrans G, Fryden A, Braconier JH, Sonnerborg A, Weiland O. Randomised, double-blind, placebo-controlled trial of interferon alpha-2b with and without ribavirin for chronic hepatitis C. The Swedish Study Group. Lancet. 1998;351:83-7.
11) Schalm SW, Brouwer JT, Chemello L, et al. Interferon-ribavirin combination therapy for chronic hepatitis C. Dig.Dis.Sci. 1996;41:131S-4S.
12) Schalm SW, Fattovich G, Brouwer JT. Therapy of hepatitis C: patients with cirrhosis. Hepatology. 1997;26:128S-32S.
13) Schalm SW, Hansen BE, Chemello L, et al. Ribavirin enhances the efficacy but not the adverse effects of interferon in chronic hepatitis C. Meta-analysis of individual patient data from European centers. J.Hepatol. 1997;26:961-6.
14) Schvarcz R, Yun ZB, Sonnerborg A, Weiland O. Combined treatment with interferon alpha-2b and ribavirin for chronic hepatitis C in patients with a previous non-response or non-sustained response to interferon alone. J.Med.Virol. 1995;46:43-7.
compiled by Robert G. Gish, M.D.