|LE Magazine December 1998 |
Ribavarin Study Supports
Hepatitis C has killed tens of thousands of Americans whose lives could have been saved if it were not for the Food and Drug Administration's political bias against a drug with proven efficacy. As detailed in previous issues of Life Extension magazine, ribavirin is a broad-spectrum anti-viral drug that has been shown to significantly suppress hepatitis C infection when combined with interferon-alpha. The fda finally approved ribavirin in 1998 to treat adult hepatitis C patients, but with a catch: hepatitis C patients must first fail a grueling six-month regimen of interferon therapy before they are allowed to use combination interferon-ribavirin therapy.
The hepatitis C virus inflicts massive damage to liver cells that often leads to cirrhosis and primary liver cancer. It is crucial for those infected with the hepatitis C virus to eliminate the virus from their bodies before it causes irreversible liver damage. The scientific literature supports the use of ribavirin and interferon as the primary treatment for most hepatitis C infections. But since interferon therapy by itself is effective only in 20 percent of cases, the fda's ban on using combination interferon-ribavirin therapy condemns 80 percent of hepatitis C patients to treatment failure and severe liver damage.
The Life Extension Foundation believes that the fda's suppression of ribavirin provides a common-sense example of just how incompetent the agency is at evaluating scientific data. The Foundation has spent hundreds of thousands of dollars exposing the fda's failure to approve ribavirin; this most recent issue provides additional blatant evidence of fda fraud and incompetence.
The latest ribavirin study was published in British medical journal The Lancet (1998, Vol 351, Issue 9096, pages 83-87). In this double-blind trial, 100 patients were randomly assigned to treatment either with interferon in combination with ribavirin, or with interferon plus placebo, for 24 weeks. The primary endpoint to the study was eradication of the hepatitis C. The findings of the study showed that 36 percent of the patients in the interferon-and-ribavirin group experienced elimination of the virus from the blood, compared with only 18 percent of patients in the interferon-and-placebo group. The scientists concluded that patients with high levels of the hepatitis C virus in their blood should be treated with interferon and ribavirin.
As is obvious, the addition of ribavirin to interferon therapy doubled the number of hepatitis C patients who experienced eradication of the virus from their blood, according to the study published in The Lancet. This new report confirms previous studies showing a consistent 50-percent improvement in hepatitis C therapy when ribavirin is added to standard interferon therapy.
While the fda has not approved ribavirin as the primary therapy to treat hepatitis C, your doctor may be able to prescribe it to you. You probably won't get insurance reimbursement, since the fda doesn't approve of ribavirin until failure with interferon therapy by itself first occurs. The brand name for the FDA-approved ribavirin-interferon combination treatment is Rebetron, available from Schering-Plough (the company does not sell ribavirin by itself).
The fda says it is illegal for anyone selling ribavirin to promote its use for unapproved uses. Since the Life Extension Foundation does not sell ribavirin, we can inform members and their doctors about using ribavirin for unapproved uses. (For complete information about ribavirin safety precautions and dosage, refer to the September issue of Life Extension magazine.)
Foundation members are provided with information to enable them to sometimes escape from the FDA's death camp. The problem is, there are thousands of other life-saving therapies being denied by the FDA. We encourage everyone to inform their members of Congress about fda atrocities that have become the leading cause of disability and death in the United States.
Ribavirin-Interferon vs. Hepatitis C
The following is the actual scientific abstract from the medical journal The Lancet that details the efficacy of ribavirin-interferon therapy in the treatment of hepatitis C.
Randomized, double-blind, placebo-controlled trial of interferon alpha-2b with and without ribavirin for chronic hepatitis C. Lancet, 1998, Vol 351, Iss 9096, pp 83-87
Background: Pilot studies suggested that more patients with chronic hepatitis C virus (HCV) infection had a sustained virological response when treated with the combination of interferon alpha-2b and ribavirin than with interferon alpha-2b alone. We investigated the biochemical and virological responses and safety of treatment with interferon alpha-2b and ribavirin compared with interferon alpha-2b alone.
Methods: In this double-blind trial, 100 patients were randomly assigned to treatment with interferon alpha-2b (3 MU three times a week) in combination with ribavirin (1,000 or 1,200 mg per day) or placebo for 24 weeks and then followed up for a further 24 weeks. A further followup was done 1 year after active treatment stopped. The primary endpoint was the sustained virological response, defined as no detectable HCV RNA by PCR at both week 24 and week 48. Retrospectively, the baseline HCV-RNA load was analyzed as a predictor of a sustained virological response. Data were analyzed by intention to treat.
Findings: 18 (36%) of the 50 patients in the interferon alpha-2b and ribavirin group had a sustained virological response, compared with nine (18%) of the 50 patients in the interferon alpha-2b and placebo group (p=0.047). At the 1 year follow-up, the proportion of patients with virological response was greater in the interferon alpha-2b and ribavirin group than the interferon alpha-2b and placebo group (42% vs. 20%, p=0.03), respectively. More patients with baseline HCV-RNA concentrations greater than 3x10(6) genome equivalents (Eq) per mL had a sustained response with interferon alpha-2b and ribavirin than with interferon alpha-2b and placebo (12/29 vs. 1/26, p=0.009), whereas the sustained response did not differ between the two treatment groups for HCV-RNA amounts less than 3x10(6) Eq per mt (6/21 vs 8/24, p=0.67), respectively.
Interpretation: More patients with chronic hepatitis C have a sustained virological response with interferon alpha-2b and ribavirin than with only interferon alpha-2b treatment. We suggest that patients with high HCV-RNA loads should be treated with interferon alpha-2b and ribavirin. -
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