Trial Outcomes & Findings for A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults (NCT NCT02582632)

NCT ID: NCT02582632

Last Updated: 2021-07-30

Results Overview

SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 166 participants
• Primary outcome timeframe: 12 weeks after the last actual dose of study drug
• Results posted on: 2021-07-30

Participant Flow

Participant milestones

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Study STARTED	166
Overall Study COMPLETED	165
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Study Other	1

Baseline Characteristics

A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults

Baseline characteristics by cohort

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=166 Participants ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Age, Continuous	51.3 years STANDARD_DEVIATION 13.42 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants

PRIMARY outcome

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

Population: Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug. Flanking imputation.

SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

Outcome measures

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=166 Participants ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	97.6 percentage of participants Interval 95.3 to 99.9

SECONDARY outcome

Timeframe: Up to 8 weeks while on treatment

Population: ITT population: all enrolled participants who received at least 1 dose of study drug.

On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution.

Outcome measures

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=166 Participants ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Percentage of Participants With On-Treatment Virologic Failure During Treatment Period	0.6 percentage of participants Interval 0.0 to 1.8

SECONDARY outcome

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

Population: ITT population: all enrolled participants who received at least 1 dose of study drug. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis.

Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.

Outcome measures

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=163 Participants ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Percentage of Participants With Post-Treatment Relapse12	1.2 percentage of participants Interval 0.0 to 2.9

SECONDARY outcome

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

Population: ITT population: all enrolled female participants who received at least 1 dose of study drug. Flanking imputation.

SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

Outcome measures

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=94 Participants ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Percentage of Female Participants Responding With SVR12	97.9 percentage of participants Interval 95.0 to 100.0

SECONDARY outcome

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

Population: ITT population: all enrolled participants who received at least 1 dose of study drug and with baseline HCV RNA \< 6,000,000 IU/mL. Flanking imputation.

SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

Outcome measures

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=154 Participants ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12	98.1 percentage of participants Interval 95.9 to 100.0

OTHER_PRE_SPECIFIED outcome

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

Population: The modified ITT (mITT)-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Flanking imputation.

SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

Outcome measures

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=163 Participants ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Percentage of Participants Who Achieve SVR12: mITT-GT Population	98.2 percentage of participants Interval 96.1 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 8 weeks while on treatment

Population: The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection.

On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method.

Outcome measures

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=163 Participants ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population	0 percentage of participants Interval 0.0 to 2.3

OTHER_PRE_SPECIFIED outcome

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

Population: The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis.

Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.

Outcome measures

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=161 Participants ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population	1.2 percentage of participants Interval 0.0 to 3.0

OTHER_PRE_SPECIFIED outcome

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

Population: The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; female participants. Flanking imputation.

SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

Outcome measures

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=93 Participants ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Percentage of Female Participants Responding With SVR12: mITT-GT Population	97.8 percentage of participants Interval 94.9 to 100.0

OTHER_PRE_SPECIFIED outcome

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

Population: The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; participants with baseline HCV RNA \< 6,000,000 IU/mL. Flanking imputation.

SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

Outcome measures

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=151 Participants ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population	98.7 percentage of participants Interval 96.9 to 100.0

Adverse Events

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir

Serious events: 2 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=166 participants at risk ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Infections and infestations GASTROENTERITIS	0.60% 1/166 • 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 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug). A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.
Nervous system disorders SYNCOPE	0.60% 1/166 • 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 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug). A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.

Other adverse events

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n=166 participants at risk ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Gastrointestinal disorders NAUSEA	6.6% 11/166 • 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 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug). A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.
General disorders ASTHENIA	5.4% 9/166 • 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 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug). A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.
General disorders FATIGUE	16.9% 28/166 • 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 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug). A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.
Infections and infestations NASOPHARYNGITIS	8.4% 14/166 • 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 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug). A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.
Nervous system disorders HEADACHE	21.1% 35/166 • 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 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug). A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.
Skin and subcutaneous tissue disorders PRURITUS	8.4% 14/166 • 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 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug). A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.

Additional Information

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