Trial Outcomes & Findings for Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (NCT NCT02609659)

NCT ID: NCT02609659

Last Updated: 2019-12-10

Results Overview

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 105 participants
• Primary outcome timeframe: 12 weeks after the last actual dose of study drug
• Results posted on: 2019-12-10

Participant Flow

Participant milestones

Measure	3-DAA + RBV 600 mg 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
Overall Study STARTED	105
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	3-DAA + RBV 600 mg 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	6
Overall Study Other	1

Baseline Characteristics

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection

Baseline characteristics by cohort

Measure	3-DAA + RBV 600 mg n=105 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
Age, Continuous	49.8 years STANDARD_DEVIATION 13.03 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants

PRIMARY outcome

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

Population: Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after flanking imputation were counted as nonresponders.

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.

Outcome measures

Measure	3-DAA + RBV 600 mg n=105 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	89.5 percentage of participants Interval 83.7 to 95.4

PRIMARY outcome

Timeframe: up to 12 weeks

Population: All participants who received at least 1 dose of study drug (ITT population) with at least one post-baseline hemoglobin value through the final treatment value.

The percentage of participants with hemoglobin <10 g/dL during treatment is provided.

Outcome measures

Measure	3-DAA + RBV 600 mg n=104 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
Percentage of Participants With Hemoglobin < 10 g/dL During Treatment	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)

Population: All participants who received at least 1 dose of study drug (ITT population) with a hemoglobin value at baseline and at given timepoint.

The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.

Outcome measures

Measure	3-DAA + RBV 600 mg n=104 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
Mean Change in Hemoglobin Values From Baseline to End of Treatment Week 2	-6.4 g/L Standard Deviation 8.17
Mean Change in Hemoglobin Values From Baseline to End of Treatment Week 4	-8.9 g/L Standard Deviation 9.37
Mean Change in Hemoglobin Values From Baseline to End of Treatment Week 8	-11.2 g/L Standard Deviation 9.85
Mean Change in Hemoglobin Values From Baseline to End of Treatment Week 12	-12.4 g/L Standard Deviation 10.06
Mean Change in Hemoglobin Values From Baseline to End of Treatment Final Treatment Visit	-12.1 g/L Standard Deviation 9.90

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: All participants who received at least 1 dose of study drug (ITT population).

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment.

Outcome measures

Measure	3-DAA + RBV 600 mg n=105 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
Percentage of Participants With On-treatment Virologic Failure	1.0 percentage of participants

SECONDARY outcome

Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Population: All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA \<LLOQ at the final treatment visit.

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug, excluding reinfection, among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.

Outcome measures

Measure	3-DAA + RBV 600 mg n=97 Participants 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
Percentage of Participants With Post-treatment Relapse	4.1 percentage of participants

Adverse Events

3-DAA + RBV 600 mg

Serious events: 3 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	3-DAA + RBV 600 mg n=105 participants at risk 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
Gastrointestinal disorders CYCLIC VOMITING SYNDROME	0.95% 1/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
Psychiatric disorders BIPOLAR I DISORDER	0.95% 1/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
Psychiatric disorders PSYCHOTIC DISORDER	0.95% 1/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.

Other adverse events

Measure	3-DAA + RBV 600 mg n=105 participants at risk 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.
Gastrointestinal disorders CONSTIPATION	5.7% 6/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
Gastrointestinal disorders DIARRHOEA	8.6% 9/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
Gastrointestinal disorders NAUSEA	10.5% 11/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
General disorders FATIGUE	27.6% 29/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
Infections and infestations INFLUENZA	5.7% 6/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders BACK PAIN	5.7% 6/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
Nervous system disorders HEADACHE	13.3% 14/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
Psychiatric disorders ANXIETY	6.7% 7/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.
Psychiatric disorders INSOMNIA	11.4% 12/105 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.

Additional Information

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