Trial Outcomes & Findings for Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C (NCT NCT02946034)

NCT ID: NCT02946034

Last Updated: 2021-11-05

Results Overview

Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome timeframe: 52 Weeks
• Results posted on: 2021-11-05

Participant Flow

Participant milestones

Measure	Viekira Pak ± Ribavirin or Mavyret 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients)
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C

Baseline characteristics by cohort

Measure	Viekira Pak ± Ribavirin or Mavyret n=10 Participants 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients)
Age, Continuous	65 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Hepatitis C genotype Genotype 1a	4 Participants n=5 Participants
Hepatitis C genotype Genotype 1b	2 Participants n=5 Participants
Hepatitis C genotype Genotype 2	1 Participants n=5 Participants
Hepatitis C genotype Genotype 3	2 Participants n=5 Participants
Hepatitis C genotype Genotype 4	1 Participants n=5 Participants
Baseline estimated glomerular filtration rate (eGFR) 60-89 mL/min/1.73m2	1 Participants n=5 Participants
Baseline estimated glomerular filtration rate (eGFR) 30-59 mL/min/1.73m2	4 Participants n=5 Participants
Baseline estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2	5 Participants n=5 Participants
Hypertension	10 Participants n=5 Participants
Diabetes	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 Weeks

Population: 2 patients did not have urine TNF-alpha tested at these timepoints.

Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.

To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.

Outcome measures

Measure	Viekira Pak ± Ribavirin or Mavyret n=8 Participants 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients)
Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment	-0.05 ng/g Standard Deviation 0.61

PRIMARY outcome

Timeframe: 52 weeks

Population: 2 patients did not have urine IL-6 tested at these timepoints.

Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.

To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.

Outcome measures

Measure	Viekira Pak ± Ribavirin or Mavyret n=8 Participants 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients)
Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment	5.73 ng/g Standard Deviation 12.18

PRIMARY outcome

Timeframe: 52 weeks

Population: 2 patients did not have plasma TNF-alpha tested at these timepoints.

Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.

To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.

Outcome measures

Measure	Viekira Pak ± Ribavirin or Mavyret n=8 Participants 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients)
Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment	6.67 pg/mL Standard Deviation 42.87

PRIMARY outcome

Timeframe: 52 Weeks 52 Weeks 52 weeks

Population: 2 patients did not have plasma IP-10 tested at these timepoints.

Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.

To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.

Outcome measures

Measure	Viekira Pak ± Ribavirin or Mavyret n=8 Participants 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients)
Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment	-394.57 pg/mL Standard Deviation 657.80

PRIMARY outcome

Timeframe: 52 weeks

Population: 2 patients did not have plasma IFN-gamma tested at these timepoints.

Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.

To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.

Outcome measures

Measure	Viekira Pak ± Ribavirin or Mavyret n=8 Participants 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients)
Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment	2.01 pg/mL Standard Deviation 29.57

PRIMARY outcome

Timeframe: 52 weeks

Population: 2 patients did not have plasma IL-6 tested at these timepoints.

Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.

To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.

Outcome measures

Measure	Viekira Pak ± Ribavirin or Mavyret n=8 Participants 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients)
Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment	-3.94 pg/mL Standard Deviation 11

SECONDARY outcome

Timeframe: 12 weeks

Safety and tolerability of Viekira Pak treatment in CKD patients will be assessed by number of patients who suffered adverse events (serious or otherwise) deemed to be related to study drug.

Outcome measures

Measure	Viekira Pak ± Ribavirin or Mavyret n=10 Participants 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients)
Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)	4 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: 2 patients did not have hepatitis C checked after 12-weeks post-treatment; thus, we cannot definitively determine that they achieved SVR12.

Efficacy will be determined by negative HCV RNA viral load measured during the 12 week treatment period as well as 12 weeks after the last dose.

Outcome measures

Measure	Viekira Pak ± Ribavirin or Mavyret n=8 Participants 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients)
Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)	8 Participants

Adverse Events

Viekira Pak ± Ribavirin or Mavyret

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Viekira Pak ± Ribavirin or Mavyret n=10 participants at risk 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients
Nervous system disorders Stroke	10.0% 1/10 • Number of events 1 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.
Nervous system disorders Seizure	10.0% 1/10 • Number of events 1 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.
Nervous system disorders Fall / loss of consciousness	10.0% 1/10 • Number of events 1 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Number of events 1 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.
Renal and urinary disorders Cryoglobulinemic glomerulonephritis	10.0% 1/10 • Number of events 1 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.
Cardiac disorders Heart block	10.0% 1/10 • Number of events 1 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.
Cardiac disorders Hypertensive emergency	10.0% 1/10 • Number of events 1 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.

Other adverse events

Measure	Viekira Pak ± Ribavirin or Mavyret n=10 participants at risk 12 week therapy with Viekira Pak ± ribavirin (2 patients) 8 or 12 week therapy with Mavyret (8 patients
Musculoskeletal and connective tissue disorders muscle pain in leg	10.0% 1/10 • Number of events 1 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.
Blood and lymphatic system disorders anemia	10.0% 1/10 • Number of events 1 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.
Nervous system disorders fatigue	30.0% 3/10 • Number of events 3 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.
Blood and lymphatic system disorders cryoglobulinemia	10.0% 1/10 • Number of events 1 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.
Cardiac disorders slow ventricular response	10.0% 1/10 • Number of events 2 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.
Renal and urinary disorders high potassium	10.0% 1/10 • Number of events 1 • Each patient was followed for one year after initiation of treatment. Adverse events data collection was done at each study visit.

Additional Information

Dr. Raymond Chung

Massachusetts General Hospital

Phone: 617-726-5925

Email: Chung.Raymond@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place