Trial Outcomes & Findings for Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults (NCT NCT02399345)

Last Updated: 2016-12-12

Results Overview

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

10 participants

Primary outcome timeframe

12 weeks after the last actual dose of study drug

Results posted on

2016-12-12

Participant Flow

A total 10 participants were enrolled in the first arm (ombitasvir/paritaprevir/r, dasabuvir, and SOF plus RBV for 6 weeks); based on inadequate efficacy in the first arm, subsequent arms (4 weeks of treatment; with or without RBV) were not enrolled per protocol.

Participant milestones

Participant milestones
Measure	Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV n=10 Participants Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Age, Continuous	46.4 years STANDARD_DEVIATION 11.30 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV n=10 Participants Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment	80 percentage of participants

SECONDARY outcome

Timeframe: 6 weeks

Population: ITT population

Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment).

Outcome measures

Outcome measures
Measure	Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV n=10 Participants Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Percentage of Subjects With On-treatment Virologic Failure	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks after last actual dose of active study drug

Population: ITT population

Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment

Outcome measures

Outcome measures
Measure	Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV n=10 Participants Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Percentage of Subjects With Post-treatment Relapse	20 percentage of participants

Adverse Events

Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV n=10 participants at risk Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Psychiatric disorders ANXIETY	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Social circumstances PHYSICAL ASSAULT	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).

Other adverse events

Other adverse events
Measure	Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV n=10 participants at risk Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Metabolism and nutrition disorders DECREASED APPETITE	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	20.0% 2/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Musculoskeletal and connective tissue disorders ARTHRITIS	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Ear and labyrinth disorders EAR DISCOMFORT	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Eye disorders DRY EYE	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Gastrointestinal disorders CONSTIPATION	20.0% 2/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Gastrointestinal disorders FLATULENCE	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	20.0% 2/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Gastrointestinal disorders NAUSEA	20.0% 2/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
General disorders ASTHENIA	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
General disorders CHILLS	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
General disorders FATIGUE	50.0% 5/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
General disorders INFLAMMATION	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Infections and infestations GASTROENTERITIS	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Infections and infestations ORAL HERPES	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Infections and infestations TOOTH INFECTION	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	30.0% 3/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Infections and infestations VIRAL INFECTION	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Injury, poisoning and procedural complications CONCUSSION	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Injury, poisoning and procedural complications HAIR INJURY	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Musculoskeletal and connective tissue disorders BACK PAIN	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Musculoskeletal and connective tissue disorders MYALGIA	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Musculoskeletal and connective tissue disorders POLYARTHRITIS	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Nervous system disorders DIZZINESS	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Nervous system disorders DYSGEUSIA	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Nervous system disorders HEADACHE	30.0% 3/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Nervous system disorders MENTAL IMPAIRMENT	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Nervous system disorders NEURALGIA	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Psychiatric disorders AGORAPHOBIA	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Psychiatric disorders INSOMNIA	50.0% 5/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Psychiatric disorders IRRITABILITY	20.0% 2/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Psychiatric disorders NIGHTMARE	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Renal and urinary disorders POLLAKIURIA	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Respiratory, thoracic and mediastinal disorders ASTHMA	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	20.0% 2/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Respiratory, thoracic and mediastinal disorders EPISTAXIS	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Skin and subcutaneous tissue disorders DRY SKIN	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Skin and subcutaneous tissue disorders ECZEMA	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Skin and subcutaneous tissue disorders ONYCHOCLASIS	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Skin and subcutaneous tissue disorders PRURITUS	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).
Skin and subcutaneous tissue disorders SKIN ATROPHY	10.0% 1/10 • Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 10 weeks); Serious Adverse Events (SAEs) were collected from the time informed consent was obtained (up to 15 weeks).

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