In March 2009, Schering-Plow Corporation announced that the United States Food and Drug Administration (FDA) had approved the expansion of the indications for combination therapy for chronic hepatitis C, including peginterferon. Combination therapy with peginterferon alfa-2b (PegIntron) and ribavirin (Rebetol) currently has no restrictions on use only in patients who have not received treatment before and may be prescribed for the treatment of chronic hepatitis C in patients aged 3 years and older with compensated liver disease.

After the approval of this extension of the indications for polytherapy based on these indications, doctors have a new possibility of therapy - the treatment of patients in whom the previous therapy has not been effective.

In the U.S., this combination regimen, including peginterferon, is the first and to date the only regimen available that has no restrictions on administering it only to patients who have not received treatment before.. This offers significant therapeutic benefits for a certain category of patients who have not received the effect of previous treatment for chronic hepatitis C. The number of these patients is constantly increasing and currently exceeds 100,000 in the United States. United.

Factors that may be associated with a lower likelihood of treatment success after ineffective prior therapy include a lack of response to the main therapy, prior use of pegylated interferon, severe bridged fibrosis or cirrhosis, and infection caused by hepatitis C virus genotype 1

Based on previous treatment data, doctors can identify patients who are eligible for new treatment using combination therapy containing peginterferon, and in such cases there is a real chance of a lasting response to treatment.

The FDA has approved this extension of evidence based on data from one of the clinical trials - the evaluation of PEG-INTRON in the control of hepatitis C cirrhosis - EPIC3 study in which carrying out undetectable L Hepatitis C virus (HCV) RNA at week 12 was an important prognostic factor (predictor) for a persistent virological response.

In this unique study, 2,293 adults with mild or severe fibrosis or cirrhosis who did not respond to previous combination therapy with interferon alfa and ribavirin for at least 12 weeks received peginterferon alfa-2b (1.5 mg / kg once a week) and ribavirin (800-1400 mg per day, depending on body weight). The study included patients who had not responded to previous treatment and had detectable HCV RNA level after 12 weeks of treatment and patients with relapses in which the virus RNA level had not been determined at the end of the previous treatment, then relapsed.

The treatment response rate, which was assessed as an undetectable level of hepatitis C virus RNA 24 weeks after the end of treatment, was 22% overall. At week 12 of treatment, 64% of patients did not reach an undetectable level of viral RNA and were invited to participate in long-term clinical trials. In people with undetectable HCV RNA at week 12 in patients with 1 virus genotype, the rate of achieving a persistent virological response was 48% versus 70% in patients with 2 or 3 HCV genotypes. For all genotypes of HCV, a general pattern was revealed - in patients with more pronounced fibrosis, the probability of achieving a persistent virological response was lower.

Whatever the genotype of the virus, the recommended duration of treatment with a combination therapy containing peginterferon alfa-2b is 48 weeks. In patients with detectable HCV RNA levels at week 12 or 24 who are being reprocessed, it is unlikely that a persistent virological response will be obtained; therefore, it should be determined whether treatment should be discontinued.

The adverse events associated with the prescription of peginterferon alfa-2b and ribavirin for reprocessing were comparable to the adverse events reported in clinical trials in patients who had not previously received treatment. Interferon alpha therapy requires careful monitoring of clinical and laboratory parameters, as it can cause life-threatening or potentially fatal neurological, mental, autoimmune, ischemic, and infectious diseases.

Ribavirin can have a teratogenic effect, therefore pregnancy should be avoided not only in patients receiving treatment, but also in female partners of male patients undergoing treatment. Ribavirin can also cause hemolytic anemia and should be considered a potential carcinogen.