Infectious Diseases

Antiviral therapy for chronic hepatitis C with cepeginterferon-?2b in combination with ribavirin

The objective. To compare efficacy and safety of Algeron 1.5 and 2.0 ?g/kg with PegIntron in combination with ribavirin in the treatment of chronic hepatitis C and to determine therapeutic dose of Algeron. Patients  and  methods.  The  study  included  150  treatment-naive  adult  patients  (al   genotypes)  with  chronic  hepatitis  C. Patients  were  randomized  into  3  treatment  groups.  Patients  in  the  two  main  groups  have  received  Algeron  at  a  dose  of 1.5 or 2.0 mg/kg/week in combination with ribavirin (800–1,400 mg/day), in the active control group – peginterferon alfa-2b 1.5 ?g/kg/week in combination with ribavirin (800–1,400 mg/day). Results. Comparative analysis of the frequency of achievement of virological response at 4th and 12th weeks of therapy, end-of-treatment  response  and  biochemical  response  did  not  show  any  statistically  significant  differences  between the groups. Rapid virological response (RVR) was observed in 64% and 56% of patients of patients receiving Algeron 1.5 and 2.0 ?g/kg, respectively, in the PegIntron group – in 66% (p >- 0,05). The frequency of early virological response (EVR) in Algeron groups after 12 weeks of treatment (regardless of a dose – 1.5 or 2.0 ?g/kg) was 94%, in the reference group (PegIntron) – 88% (p >- 0,05). End-of-treatment response (EOT) among patients receiving Algeron at a dose 1.5 ?g/kg was recorded in 84% of cases- in the group of patients using Algeron at a dose 2.0 ?g/kg – in 88%- in the reference group – in  76%.  RVR,  EVR,  and  EOT  rate  analysis  according  to  HCV  genotype  also  did  not  showed  statistically  significant differences  between  the  groups.  Safety  profiles  of  Algeron  and  PegIntron  were  similar.  The  complex  assessment  of the  efficacy  and  safety  allowed  to  make  the  conclusion  about  the  optimal  therapeutic  dose  of  Algeron,  equal  to 1.5 ?g/kg/week. Conclusion. Results of the study provide evidence of the high efficacy and safety of Algeron for suppression of HCV replication and make it possible to recommend Algeron 1.5 ?g/kg weekly in combination with ribavirin for the treatment of chronic hepatitis C in antiviral therapy-naive patients for 24–48 weeks depending on the HCV genotype.