A Phase 2 interventional study of Grazoprevir and Boceprevir in Hepatitis C, Chronic, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin (RBV) in treatment-naïve (TN) participants with chronic hepatitis C.
Amendment 4 unblinded treatment after an interim analysis for all subsequently enrolled TN participants (the Second Cohort) who were receiving grazoprevir 400 or 800 mg daily, and they were down-dosed to 100 mg daily between Treatment Week (TW) 3 and TW12 for the remainder of the 12-week treatment course.
Amendment 5 allowed treatment-naïve participants with chronic hepatitis C and compensated cirrhosis to be enrolled and receive open-label grazoprevir 100 mg in combination with Peg-IFN and RBV, without a corresponding control arm.
1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.
This study's enrollment of 368 is above the median of 90 across 789 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
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Exclusion Criteria:
TN non-cirrhotic (NC) participants receive Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
Drug: Grazoprevir · Drug: Placebo for Boceprevir · Drug: Peg-interferon alfa-2b · Drug: Ribavirin
TN NC participants receive Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
Drug: Grazoprevir · Drug: Placebo for Boceprevir · Drug: Peg-interferon alfa-2b · Drug: Ribavirin
TN NC participants receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
Drug: Grazoprevir · Drug: Placebo for Boceprevir · Drug: Peg-interferon alfa-2b · Drug: Ribavirin
TN NC participants receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
Drug: Grazoprevir · Drug: Placebo for Boceprevir · Drug: Peg-interferon alfa-2b · Drug: Ribavirin
TN NC participants start a 4 week lead-in with Peg-IFN + RBV, then receive Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
Drug: Boceprevir · Drug: Placebo for Grazoprevir · Drug: Peg-interferon alfa-2b · Drug: Ribavirin
As the result of an interim analysis, TN NC participants assigned to the 400 mg grazoprevir group were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV and will remain in the study.
Drug: Grazoprevir · Drug: Peg-interferon alfa-2b · Drug: Ribavirin
As the result of an interim analysis, TN NC participants assigned to the 800 mg grazoprevir group were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV and will remain in the study.
Drug: Grazoprevir · Drug: Peg-interferon alfa-2b · Drug: Ribavirin
TN cirrhotic participants receive open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
Drug: Grazoprevir · Drug: Peg-interferon alfa-2b · Drug: Ribavirin
Orally once daily in AM. Blinded or open-label depending on treatment arm.
Four 200 mg capsules orally three times daily.
Also known as: Victrelis
Orally once daily in AM.
Four capsules orally three times daily.
1.5 μg/kg/week subcutaneous injection.
Also known as: PegIntron, Peg-IFN alfa-2b
300 mg to 700 mg orally twice daily.
Also known as: Rebetol
Percentage of Participants Achieving Complete Early Viral Response (cEVR)
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). cEVR was defined as undetectable HCV RNA (target not detected \[TND\]) at Week 12. 95% confidence intervals provided based on the Clopper-Pearson method.
Time frame: After 12 weeks of treatment with grazoprevir/boceprevir
Number of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
Time frame: Treatment period plus the first 14 days of follow-up (up to 50 weeks)
Number of Participants Who Discontinued Study Medication Due to AEs During the Treatment Period and First 14 Follow-up Days
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
Time frame: Treatment period plus the first 14 days of follow-up (up to 50 weeks)
Median Time to First Achievement of Undetectable HCV RNA During Treatment
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected \[TND\]) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm.
Time frame: From first dose of study medication until first achievement of undetectable HCV RNA (up to 48 weeks of treatment)
Percentage of Participants Achieving Rapid Viral Response (RVR)
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). RVR was defined as undetectable (TND) HCV RNA at Week 4 of study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.
Time frame: After 4 weeks of treatment with grazoprevir/boceprevir
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of Study Therapy (SVR12)
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (TND) HCV RNA at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.
Time frame: 12 weeks after the end of all treatment (up to 60 weeks)
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR24)
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (TND) HCV RNA at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.
Time frame: 24 weeks after the end of all treatment (up to 72 weeks)
Percentage of Participants Achieving Undetectable HCV RNA at Week 72
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected \[TND\]) was defined as below the 9.3 IU/ml limit of detection. 95% confidence intervals provided based on the Clopper-Pearson method.
Time frame: Week 72
| Milestone | OL Grazoprevir 100 mg | Grazoprevir 100 mg | Grazoprevir 200 mg | Grazoprevir 400 mg | Grazoprevir 800 mg | Grazoprevir 400 mg/100 mg | Grazoprevir 800 mg/100 mg | Boceprevir 800 mg |
|---|---|---|---|---|---|---|---|---|
| Started | 36 | 66 | 68 | 24 | 29 | 43 | 36 | 66 |
| Completed | 28 | 57 | 59 | 22 | 23 | 36 | 30 | 51 |
| Not completed | 8 | 9 | 9 | 2 | 6 | 7 | 6 | 15 |
| Withdrew: Lost to follow-up | 2 | 6 | 4 | 0 | 4 | 4 | 3 | 6 |
| Withdrew: Withdrawal by subject | 2 | 3 | 4 | 2 | 2 | 3 | 3 | 9 |
| Withdrew: Status not recorded | 4 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). cEVR was defined as undetectable HCV RNA (target not detected \[TND\]) at Week 12. 95% confidence intervals provided based on the Clopper-Pearson method.
| percentage of participants | OL Grazoprevir 100 mg | Grazoprevir 100 mg | Grazoprevir 200 mg | Grazoprevir 400 mg | Grazoprevir 800 mg | Grazoprevir 400 mg/100 mg | Grazoprevir 800 mg/100 mg | Boceprevir 800 mg |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Achieving Complete Early Viral Response (cEVR) | 94.4 (81.3 to 99.9) | 80.3 (68.7 to 89.1) | 85.3 (74.6 to 92.7) | 87.5 (67.6 to 97.3) | 75.9 (56.5 to 89.7) | 86.0 (72.1 to 94.7) | 86.1 (70.5 to 95.3) | 69.7 (57.1 to 80.4) |
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
| participants | OL Grazoprevir 100 mg | Grazoprevir 100 mg | Grazoprevir 200 mg | Grazoprevir 400 mg | Grazoprevir 800 mg | Grazoprevir 400 mg/100 mg | Grazoprevir 800 mg/100 mg | Boceprevir 800 mg |
|---|---|---|---|---|---|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days | 34 | 65 | 66 | 23 | 28 | 42 | 35 | 64 |
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.
| participants | OL Grazoprevir 100 mg | Grazoprevir 100 mg | Grazoprevir 200 mg | Grazoprevir 400 mg | Grazoprevir 800 mg | Grazoprevir 400 mg/100 mg | Grazoprevir 800 mg/100 mg | Boceprevir 800 mg |
|---|---|---|---|---|---|---|---|---|
| Number of Participants Who Discontinued Study Medication Due to AEs During the Treatment Period and First 14 Follow-up Days | 2 | 3 | 4 | 2 | 3 | 4 | 2 | 9 |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected \[TND\]) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm.
| days | OL Grazoprevir 100 mg | Grazoprevir 100 mg | Grazoprevir 200 mg | Grazoprevir 400 mg | Grazoprevir 800 mg | Grazoprevir 400 mg/100 mg | Grazoprevir 800 mg/100 mg | Boceprevir 800 mg |
|---|---|---|---|---|---|---|---|---|
| Median Time to First Achievement of Undetectable HCV RNA During Treatment | 22.0 (21.0 to 29.0) | 15.0 (15.0 to 18.0) | 28.0 (23.0 to 29.0) | 16.0 (14.0 to 29.0) | 16.5 (14.0 to 28.0) | 27.0 (15.0 to 29.0) | 29.0 (15.0 to 29.0) | 57.0 (57.0 to 59.0) |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). RVR was defined as undetectable (TND) HCV RNA at Week 4 of study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.
| percentage of participants | OL Grazoprevir 100 mg | Grazoprevir 100 mg | Grazoprevir 200 mg | Grazoprevir 400 mg | Grazoprevir 800 mg | Grazoprevir 400 mg/100 mg | Grazoprevir 800 mg/100 mg | Boceprevir 800 mg |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Achieving Rapid Viral Response (RVR) | 72.2 (54.8 to 85.8) | 90.9 (81.3 to 96.6) | 91.2 (81.8 to 96.7) | 87.5 (67.6 to 97.3) | 86.2 (68.3 to 96.1) | 81.4 (66.6 to 91.6) | 83.3 (67.2 to 93.6) | 59.1 (46.3 to 71.0) |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (TND) HCV RNA at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.
| percentage of participants | OL Grazoprevir 100 mg | Grazoprevir 100 mg | Grazoprevir 200 mg | Grazoprevir 400 mg | Grazoprevir 800 mg | Grazoprevir 400 mg/100 mg | Grazoprevir 800 mg/100 mg | Boceprevir 800 mg |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of Study Therapy (SVR12) | 72.2 (54.8 to 85.8) | 89.4 (79.4 to 95.6) | 91.2 (81.8 to 96.7) | 87.5 (67.6 to 97.3) | 79.3 (60.3 to 92.0) | 93.0 (80.9 to 98.5) | 91.7 (77.5 to 98.2) | 60.6 (47.8 to 72.4) |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (TND) HCV RNA at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.
| percentage of participants | OL Grazoprevir 100 mg | Grazoprevir 100 mg | Grazoprevir 200 mg | Grazoprevir 400 mg | Grazoprevir 800 mg | Grazoprevir 400 mg/100 mg | Grazoprevir 800 mg/100 mg | Boceprevir 800 mg |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR24) | 72.2 (54.8 to 85.8) | 86.4 (75.7 to 93.6) | 92.6 (83.7 to 97.6) | 87.5 (67.6 to 97.3) | 79.3 (60.3 to 92.0) | 93.0 (80.9 to 98.5) | 91.7 (77.5 to 98.2) | 57.6 (44.8 to 69.7) |
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected \[TND\]) was defined as below the 9.3 IU/ml limit of detection. 95% confidence intervals provided based on the Clopper-Pearson method.
| percentage of participants | OL Grazoprevir 100 mg | Grazoprevir 100 mg | Grazoprevir 200 mg | Grazoprevir 400 mg | Grazoprevir 800 mg | Grazoprevir 400 mg/100 mg | Grazoprevir 800 mg/100 mg | Boceprevir 800 mg |
|---|---|---|---|---|---|---|---|---|
| Percentage of Participants Achieving Undetectable HCV RNA at Week 72 | 69.4 (51.9 to 83.7) | 80.3 (68.7 to 89.1) | 86.8 (76.4 to 93.8) | 87.5 (67.6 to 97.3) | 75.9 (56.5 to 89.7) | 79.1 (64.0 to 90.0) | 83.3 (67.2 to 93.6) | 54.5 (41.8 to 66.9) |
Collected over From first dose of study medication up to 72 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cirr: OL Grazoprevir 100 mg | — | 3/36 (8.3%) | 34/36 (94.4%) |
| Non-cirr: Grazoprevir 100 mg | — | 6/66 (9.1%) | 64/66 (97%) |
| Non-cirr: Grazoprevir 200 mg | — | 9/68 (13.2%) | 65/68 (95.6%) |
| Non-cirr: Grazoprevir 400 mg | — | 2/24 (8.3%) | 23/24 (95.8%) |
| Non-cirr: Grazoprevir 800 mg | — | 2/29 (6.9%) | 27/29 (93.1%) |
| Non-cirr: Grazoprevir 400 mg/100 mg | — | 5/43 (11.6%) | 42/43 (97.7%) |
| Non-cirr: Grazoprevir 800 mg/100 mg | — | 4/36 (11.1%) | 36/36 (100%) |
| Non-cirr: Boceprevir 800 mg | — | 5/66 (7.6%) | 64/66 (97%) |
| Event | Cirr: OL Grazoprevir 100 mg | Non-cirr: Grazoprevir 100 mg | Non-cirr: Grazoprevir 200 mg | Non-cirr: Grazoprevir 400 mg | Non-cirr: Grazoprevir 800 mg | Non-cirr: Grazoprevir 400 mg/100 mg | Non-cirr: Grazoprevir 800 mg/100 mg | Non-cirr: Boceprevir 800 mg |
|---|---|---|---|---|---|---|---|---|
| DehydrationMetabolism and nutrition disorders | 0/36 | 0/66 | 0/68 | 2/24 | 0/29 | 0/43 | 0/36 | 0/66 |
| Schizoaffective disorderPsychiatric disorders | 0/36 | 0/66 | 0/68 | 0/24 | 1/29 | 0/43 | 0/36 | 0/66 |
| Intermittent claudicationVascular disorders | 0/36 | 0/66 | 0/68 | 0/24 | 1/29 | 0/43 | 0/36 | 0/66 |
| Peripheral vascular disorderVascular disorders | 0/36 | 0/66 | 0/68 | 0/24 | 1/29 | 0/43 | 0/36 | 0/66 |
| AnaemiaBlood and lymphatic system disorders | 1/36 | 0/66 | 1/68 | 0/24 | 0/29 | 0/43 | 0/36 | 0/66 |
| Abdominal painGastrointestinal disorders | 1/36 | 0/66 | 0/68 | 0/24 | 0/29 | 0/43 | 0/36 | 0/66 |
| DiarrhoeaGastrointestinal disorders | 1/36 | 0/66 | 0/68 | 0/24 | 0/29 | 0/43 | 0/36 | 0/66 |
| NauseaGastrointestinal disorders | 1/36 | 0/66 | 0/68 | 0/24 | 0/29 | 0/43 | 0/36 | 0/66 |
| VomitingGastrointestinal disorders | 1/36 | 0/66 | 0/68 | 0/24 | 0/29 | 0/43 | 0/36 | 0/66 |
| Chest painGeneral disorders | 0/36 | 0/66 | 0/68 | 0/24 | 0/29 | 1/43 | 1/36 | 0/66 |
| Event | Cirr: OL Grazoprevir 100 mg | Non-cirr: Grazoprevir 100 mg | Non-cirr: Grazoprevir 200 mg | Non-cirr: Grazoprevir 400 mg | Non-cirr: Grazoprevir 800 mg | Non-cirr: Grazoprevir 400 mg/100 mg | Non-cirr: Grazoprevir 800 mg/100 mg | Non-cirr: Boceprevir 800 mg |
|---|---|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 9/36 | 25/66 | 25/68 | 6/24 | 16/29 | 15/43 | 19/36 | 31/66 |
| FatigueGeneral disorders | 18/36 | 27/66 | 31/68 | 11/24 | 16/29 | 17/43 | 15/36 | 27/66 |
| HeadacheNervous system disorders | 12/36 | 28/66 | 31/68 | 8/24 | 12/29 | 12/43 | 17/36 | 35/66 |
| PyrexiaGeneral disorders | 9/36 | 20/66 | 24/68 | 12/24 | 8/29 | 12/43 | 6/36 | 20/66 |
| Decreased appetiteMetabolism and nutrition disorders | 4/36 | 16/66 | 11/68 | 4/24 | 9/29 | 10/43 | 14/36 | 15/66 |
| DiarrhoeaGastrointestinal disorders | 5/36 | 11/66 | 11/68 | 5/24 | 11/29 | 5/43 | 12/36 | 16/66 |
| PainGeneral disorders | 8/36 | 12/66 | 12/68 | 3/24 | 11/29 | 8/43 | 4/36 | 12/66 |
| AnaemiaBlood and lymphatic system disorders | 13/36 | 11/66 | 17/68 | 2/24 | 7/29 | 5/43 | 7/36 | 18/66 |
| Influenza like illnessGeneral disorders | 9/36 | 14/66 | 20/68 | 7/24 | 5/29 | 15/43 | 7/36 | 23/66 |
| ChillsGeneral disorders | 10/36 | 20/66 | 19/68 | 6/24 | 10/29 | 12/43 | 11/36 | 15/66 |
Full Analysis Set (FAS); all randomized/enrolled participants who received ≥1 dose of study treatment. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.
| Age, Continuous(years) | OL Grazoprevir 100 mg | Grazoprevir 100 mg | Grazoprevir 200 mg | Grazoprevir 400 mg | Grazoprevir 800 mg | Grazoprevir 400 mg/100 mg | Grazoprevir 800 mg/100 mg | Boceprevir 800 mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 54.4 ± 6.9 | 46.4 ± 11.3 | 48.3 ± 10.6 | 44.6 ± 12.5 | 50.4 ± 13.4 | 48.3 ± 11.4 | 50.3 ± 11.2 | 48.3 ± 11.2 | 48.7 ± 11.2 |
| Sex: Female, Male(Participants) | OL Grazoprevir 100 mg | Grazoprevir 100 mg | Grazoprevir 200 mg | Grazoprevir 400 mg | Grazoprevir 800 mg | Grazoprevir 400 mg/100 mg | Grazoprevir 800 mg/100 mg | Boceprevir 800 mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 14 | 25 | 32 | 12 | 15 | 15 | 13 | 29 | 155 |
| Male | 22 | 41 | 36 | 12 | 14 | 28 | 23 | 37 | 213 |
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Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Studies of the drug tested here: Grazoprevir