Trial Outcomes & Findings for PrOD for Non-Cirrhotic Patients With HCV-1b Receiving Hemodialysis (NCT NCT02874066)

NCT ID: NCT02874066

Last Updated: 2019-07-19

Results Overview

Number of participants with undetectable serum HCV RNA 12 weeks off therapy (treatment period 12 weeks)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 46 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2019-07-19

Participant Flow

64 patients screened, 18 patients excluded

Participant milestones

Measure	PTV/r/OBV/DSV Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks
Overall Study STARTED	46
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PrOD for Non-Cirrhotic Patients With HCV-1b Receiving Hemodialysis

Baseline characteristics by cohort

Measure	PTV/r/OBV/DSV n=46 Participants Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race/Ethnicity, Customized Taiwan	46 Participants n=5 Participants
Region of Enrollment Taiwan	46 Participants n=5 Participants
HCV RNA	5.60 Log10 IU/mL n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Patients who received at least one dose of PTV/r/OBV/DSV

Number of participants with undetectable serum HCV RNA 12 weeks off therapy (treatment period 12 weeks)

Outcome measures

Measure	PTV/r/OBV/DSV n=46 Participants Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks
Number of Participants With Sustained Virologic Response (SVR12)	46 Participants

SECONDARY outcome

Timeframe: 12 weeks

Number of participants with treatment-emergent adverse event (AE)-related withdrawal rate during the study

Outcome measures

Measure	PTV/r/OBV/DSV n=46 Participants Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks
Number of Participants With Treatment-emergent Adverse Event (AE)-Related Withdrawal Rate	0 Participants

SECONDARY outcome

Timeframe: 36 weeks

Number of participants with undetectable serum HCV RNA 24 weeks off therapy (treatment period 12 weeks)

Outcome measures

Measure	PTV/r/OBV/DSV n=46 Participants Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks
Number of Participants With Sustained Virologic Response (SVR24)	46 Participants

SECONDARY outcome

Timeframe: 4 weeks

Number of participants with undetectable serum HCV RNA at week 4 of treatment

Outcome measures

Measure	PTV/r/OBV/DSV n=46 Participants Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks
Number of Participants With Rapid Virologic Response (RVR)	46 Participants

SECONDARY outcome

Timeframe: 12 weeks

Number of participants with undetectable serum HCV RNA at week 12 of treatment

Outcome measures

Measure	PTV/r/OBV/DSV n=46 Participants Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks
Number of Participants With End-of-treatment Virological Response (EOTVR)	46 Participants

Adverse Events

PTV/r/OBV/DSV

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	PTV/r/OBV/DSV n=46 participants at risk Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks
Gastrointestinal disorders Acute gastroenteritis	2.2% 1/46 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Pulmonary edema	2.2% 1/46 • Number of events 1 • 6 months

Other adverse events

Measure	PTV/r/OBV/DSV n=46 participants at risk Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks PTV/r/OBV/DSV: Viekirax/Exviera for 12 weeks
Skin and subcutaneous tissue disorders Pruritus	19.6% 9/46 • Number of events 9 • 6 months
General disorders Fatigue	15.2% 7/46 • Number of events 7 • 6 months
Infections and infestations Upper respiratory tract infectioin	6.5% 3/46 • Number of events 3 • 6 months

Additional Information

Chen-Hua Liu

National Taiwan University Hospital

Phone: +886-972651880

Email: jacque_liu@mail2000.com.tw

Results disclosure agreements

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