title: Interferon alfacon-1 and ribavirin versus interferon alpha-2b and ribavirin in the treatment of chronic hepatitis C.
abstract: Despite advances in the therapy of chronic hepatitis C, a large number of patients do not respond to current therapies. The study objective was to assess whether a combination of interferon (IFN) alfacon-1 and ribavirin improves the response rate compared with a combination of INF alpha-2b and ribavirin in chronic hepatitis C subjects. The study was designed as an open-label, prospective, randomized, controlled study; 128 subjects with chronic hepatitis C were randomized to INF alfacon-1, 15 microg three times per week, plus ribavirin, 1 g/day, or IFN-alpha2b, 3 million units three times per week, plus ribavirin, 1 g/day for 48 weeks. The end point of the study was a sustained viral response, defined as undetectable HCV RNA at 24 weeks post 48 weeks of treatment. Overall, 57% of subjects in the INF alfacon-1/ribavirin group achieved a sustained antiviral response, compared with 40% of subjects in the IFN-alpha2b/ribavirin group (P = 0.052). In the subset of subjects with a high viral load, HCV RNA was successfully eradicated in more individuals who received INF alfacon-1/ribavirin than subjects who received IFN-alpha2b/ribavirin (57 versus 31%; P = 0.025). Among individuals with genotype 1 and a high viral load, the sustained antiviral response was significantly higher with INF alfacon-1/ribavirin than with IFN-alpha2b/ribavirin (46 versus 14%; P = 0.019). Adverse events were similar in both treatment groups. In conclusion, this study demonstrated that the combination of INF alfacon-1 and ribavirin provides a significantly better treatment response compared with the combination of IFN-alpha2b and ribavirin in chronic HCV subjects infected with genotype 1 and a high viral RNA load.
authors.affiliation: Walter Reed Army Medical Center, Washington, DC 20307, and Kaiser Permanente Mid-Atlantic, Falls Church, Virginia 22406, USA. maria.sjogren@na.amedd.army.mil
authors.forename: Maria H
authors.initials: MH
authors.lastname: Sjogren
authors.forename: Robert
authors.initials: R
authors.lastname: Sjogren
authors.forename: Kent
authors.initials: K
authors.lastname: Holtzmuller
authors.forename: Bradley
authors.initials: B
authors.lastname: Winston
authors.forename: Betty
authors.initials: B
authors.lastname: Butterfield
authors.forename: Stanley
authors.initials: S
authors.lastname: Drake
authors.forename: Amber
authors.initials: A
authors.lastname: Watts
authors.forename: Robin
authors.initials: R
authors.lastname: Howard
authors.forename: Milton
authors.initials: M
authors.lastname: Smith
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000201:enzymology / Q000821:virology; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000627:therapeutic use*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D007370:Interferon Type I; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D012254:Ribavirin; C050739:interferon alfacon-1; D000410:Alanine Transaminase