Hepatitis C, Hepatitis C, Chronic
Conditions
Brief summary
The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. The study will also assess whether RVR is a reliable predictor of sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment).
Interventions
PegIntron administered in accordance with approved labeling
Rebetol administered in accordance with approved labeling
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Willing to participate in the study and sign the Informed Consent Form * Established HCV infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction \[PCR\] test) * Can be treatment-naïve, have retreatment, or co-infected with HIV * Be under treatment with PegIntron in combination with ribavirin, starting up to 14 days before the screening visit
Exclusion criteria
* Participants who have not confirmed their willingness to participate in the study or have refused to sign the Free and Informed Consent Form * Prior treatment with PegIntron (combined with ribavirin or not) * History of alcohol abuse in the past 6 months * Decompensated liver disease * Severe heart disease * Decompensated thyroid disorder * Neoplasia * Type 1 diabetes mellitus - uncontrolled or hardly controlled * Seizures - uncontrolled * Primary immune deficiency * Men and women not using appropriate contraceptive methods * Pregnancy or lactation * For participants co-infected with HIV: HIV-related opportunistic disease in the past 6 months or CD4 count lower than 200 cells/mm\^3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment | Assessed at Treatment Week 4 | Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Sustained Virologic Response (SVR) | Assessed at 24 weeks post-treatment | SVR was defined as non-detectable HCV RNA 24 weeks post-treatment. |
| Number of Participants With RVR Who Also Achieved SVR | Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR) | RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment. |
| Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | Treatment Week 48 and Treatment Week 72 | Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5. |
| Assessment of Baseline Characteristics in Participants With SVR | 24 Weeks post-treatment | Baseline characteristics assessed were age, gender, and genotype. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mono-infected With HCV Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling. | 1,010 |
| Co-infected With HCV and HIV Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling. | 72 |
| Total | 1,082 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 62 | 4 |
| Overall Study | Adverse event + lack of efficacy | 2 | 1 |
| Overall Study | Change of treatment | 7 | 0 |
| Overall Study | Death | 11 | 0 |
| Overall Study | Lack of Efficacy | 187 | 13 |
| Overall Study | Lost to Follow-up | 87 | 10 |
| Overall Study | Other | 42 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Mono-infected With HCV | Co-infected With HCV and HIV | Total |
|---|---|---|---|
| Age, Customized <=40 years | 193 Participants | 36 Participants | 229 Participants |
| Age, Customized >40 years | 817 Participants | 36 Participants | 853 Participants |
| Region of Enrollment Brazil | 1010 participants | 72 participants | 1082 participants |
| Sex: Female, Male Female | 444 Participants | 23 Participants | 467 Participants |
| Sex: Female, Male Male | 566 Participants | 49 Participants | 615 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 762 / 1,010 | 61 / 72 | 42 / 64 |
| serious Total, serious adverse events | 52 / 1,010 | 0 / 72 | 8 / 64 |
Outcome results
Primary
Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment
Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.
Time frame: Assessed at Treatment Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mono-infected With HCV | Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment | 551 Participants |
| Co-infected With HCV and HIV | Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment | 32 Participants |
Secondary
Assessment of Baseline Characteristics in Participants With SVR
Baseline characteristics assessed were age, gender, and genotype.
Time frame: 24 Weeks post-treatment
Population: Participants with SVR
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mono-infected With HCV | Assessment of Baseline Characteristics in Participants With SVR | Age <=40 years | 75 Participants |
| Mono-infected With HCV | Assessment of Baseline Characteristics in Participants With SVR | Age >40 years | 300 Participants |
| Mono-infected With HCV | Assessment of Baseline Characteristics in Participants With SVR | male | 203 Participants |
| Mono-infected With HCV | Assessment of Baseline Characteristics in Participants With SVR | female | 172 Participants |
| Mono-infected With HCV | Assessment of Baseline Characteristics in Participants With SVR | Genotype 1 | 247 Participants |
| Mono-infected With HCV | Assessment of Baseline Characteristics in Participants With SVR | Genotype non-1 | 128 Participants |
| Co-infected With HCV and HIV | Assessment of Baseline Characteristics in Participants With SVR | Genotype 1 | 14 Participants |
| Co-infected With HCV and HIV | Assessment of Baseline Characteristics in Participants With SVR | Age <=40 years | 11 Participants |
| Co-infected With HCV and HIV | Assessment of Baseline Characteristics in Participants With SVR | female | 7 Participants |
| Co-infected With HCV and HIV | Assessment of Baseline Characteristics in Participants With SVR | Age >40 years | 13 Participants |
| Co-infected With HCV and HIV | Assessment of Baseline Characteristics in Participants With SVR | Genotype non-1 | 10 Participants |
| Co-infected With HCV and HIV | Assessment of Baseline Characteristics in Participants With SVR | male | 17 Participants |
Secondary
Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR
Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5.
Time frame: Treatment Week 48 and Treatment Week 72
Population: Participants who achieved RVR at Treatment Week 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mono-infected With HCV | Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | No SVR | 251 Participants |
| Mono-infected With HCV | Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | SVR | 300 Participants |
| Co-infected With HCV and HIV | Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | No SVR | 13 Participants |
| Co-infected With HCV and HIV | Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | SVR | 19 Participants |
Secondary
Number of Participants Who Achieved Sustained Virologic Response (SVR)
SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.
Time frame: Assessed at 24 weeks post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mono-infected With HCV | Number of Participants Who Achieved Sustained Virologic Response (SVR) | 375 Participants |
| Co-infected With HCV and HIV | Number of Participants Who Achieved Sustained Virologic Response (SVR) | 24 Participants |
Secondary
Number of Participants With RVR Who Also Achieved SVR
RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment.
Time frame: Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)
Population: Participants who achieved RVR at Treatment Week 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mono-infected With HCV | Number of Participants With RVR Who Also Achieved SVR | 300 Participants |
| Co-infected With HCV and HIV | Number of Participants With RVR Who Also Achieved SVR | 19 Participants |