In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) combination therapy. The efficacy rate (sustained virologic response, end of treatment virologic response, and sustained biochemical response), the subject morbidity rate as caused by other opportunistic infection (eg, bacterial pneumonia, tuberculosis, and other bacterial infection), and the safety and tolerability of this combination therapy will be examined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Subjects will be given peginterferon alfa-2b (PEG-IFN) subcutaneously, at a dose of 1.5 ug/kg weekly. Treatment duration will be 48 weeks for subjects with Hepatitis C Virus (HCV) genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline Hepatitis C Virus-ribonucleic acid (HCV-RNA) below 800,000 IU/mL.
Subjects will be given ribavirin 800 mg/day orally(PO) when body weight is \<65 kg, 1000 mg/day when body weight is between 65 kg and 85 kg, and 1200 mg/day when body weight is \>85 kg. Treatment duration will be 48 weeks for subjects with HCV genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline HCV-RNA below 800,000 IU/mL.
Number of Participants Who Achieved Sustained Virologic Response (SVR)
Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid \[HCV-RNA\] \<800,000 IU/mL was 24 weeks. SVR was defined as plasma HCV RNA level below lower level of quanitation at the end of 24 weeks follow-up (week 48 or 72). The study was terminated due to low enrollment. This analysis was not performed.
Time frame: Week 48 or Week 72 (depending on duration of treatment)
Number of Participants Who Achieved Virologic Response (VR)
Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid \[HCV-RNA\] \<800,000 IU/mL was 24 weeks. The study was terminated due to low enrollment. This analysis was not performed.
Time frame: 24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks)
Number of Participants Who Achieved Sustained Biochemical Response (SBR)
Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 \& 3 participants who had baseline hepatitis c virus ribonucleic acid \[HCV-RNA\] \<800,000 IU/mL was 24 weeks. SBR was defined as the presence of normal alanine aminotransferase (ALT) values at the end of 24 weeks follow-up (week 48 or 72). The study was terminated due to low enrollment. This analysis was not performed.
Time frame: Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks)
Number of Participants Experiencing Opportunistic Infection
The study was terminated due to low enrollment. This analysis was not performed.
Time frame: Throughout the study (up to 72 weeks)
Number of Participants Who Died
Time frame: Throughout the study (up to 72 weeks)
Number of Participants Experiencing Adverse Events
An adverse event was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment.
Time frame: Throughout the study (up to 72 weeks)
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