The objective is to evaluate the efficacy and safety of the combination therapy with subcutaneous (SC) Pegylated Interferon (PEG-IFN) alfa-2b 1.5 ug/kg/week plus low-dose ribavirin administered for 48 weeks in participants with chronic hepatitis C virus (HCV) who are infected with HCV genotype 1 high viral load, and weigh 50 kg or less.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks
Ribavirin 400 mg/day orally
Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation
SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity. HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result.
Time frame: Measured at 24 weeks after the end of treatment (at the end of follow-up)
Number of Participants Discontinuing Treatment
Prespecified adverse event discontinuance criteria included neutrophil count \<500 /mm3, platelet count \<50,000/mm3, and hemoglobin \<8.5 g/dL.
Time frame: From time of first treatment to Week 48
Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT
HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.
Time frame: Measured at 24 weeks of treatment and at EOT (Treatment week 48)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.