Trial Outcomes & Findings for ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection (NCT NCT02517515)

Last Updated: 2017-10-27

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 active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) who achieved SVR12 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

650 participants

Primary outcome timeframe

12 weeks after the last actual dose of active study drug

Results posted on

2017-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Double-blind 3-DAA Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.	Double-blind Placebo Followed by Open-label 3-DAA Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.
Overall Study STARTED	325	325
Overall Study COMPLETED	323	323
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Double-blind 3-DAA Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.	Double-blind Placebo Followed by Open-label 3-DAA Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.
Overall Study Adverse Event	0	1
Overall Study Withdrew Consent	0	1
Overall Study Lost to Follow-up	1	0
Overall Study Other	1	0

Baseline Characteristics

ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double-blind 3-DAA n=325 Participants Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.	Double-blind Placebo Followed by Open-label 3-DAA n=325 Participants Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.	Total n=650 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 13.84 • n=93 Participants	45.6 years STANDARD_DEVIATION 14.05 • n=4 Participants	46.2 years STANDARD_DEVIATION 13.95 • n=27 Participants
Sex: Female, Male Female	175 Participants n=93 Participants	177 Participants n=4 Participants	352 Participants n=27 Participants
Sex: Female, Male Male	150 Participants n=93 Participants	148 Participants n=4 Participants	298 Participants n=27 Participants

PRIMARY outcome

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

Population: All treatment-naïve and treatment-experienced participants who received at least 1 dose of active study drug; participants with missing data after backward imputation were counted as nonresponders.

Outcome measures

Outcome measures
Measure	Double-blind 3-DAA (Treatment-Naïve) n=184 Participants Participants who were treatment-naïve and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.	Double-blind 3-DAA (Treatment-Experienced) n=141 Participants Participants who were treatment-experienced and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	99.5 percentage of participants Interval 97.0 to 99.9	100 percentage of participants Interval 97.4 to 100.0

PRIMARY outcome

Timeframe: 24 weeks after the last actual dose of active study drug

SVR24 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 active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) who achieved SVR24 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.

Outcome measures

Outcome measures
Measure	Double-blind 3-DAA (Treatment-Naïve) n=184 Participants Participants who were treatment-naïve and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.	Double-blind 3-DAA (Treatment-Experienced) n=141 Participants Participants who were treatment-experienced and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)	99.5 percentage of participants Interval 97.0 to 99.9	100 percentage of participants Interval 97.4 to 100.0

SECONDARY outcome

Timeframe: up to 12 weeks

Population: All participants who received at least 1 dose of active study drug.

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

Outcome measures

Outcome measures
Measure	Double-blind 3-DAA (Treatment-Naïve) n=184 Participants Participants who were treatment-naïve and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.	Double-blind 3-DAA (Treatment-Experienced) n=141 Participants Participants who were treatment-experienced and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.
Percentage of Participants With On-treatment Virologic Failure	1.1 percentage of participants Interval 0.3 to 3.9	0 percentage of participants Interval 0.0 to 2.7

SECONDARY outcome

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

Population: All participants who received at least 1 dose of active study drug, completed treatment, and had HCV RNA \<LLOQ at the final treatment visit, who had HCV RNA data available during the SVR12 period.

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

Outcome measures

Outcome measures
Measure	Double-blind 3-DAA (Treatment-Naïve) n=183 Participants Participants who were treatment-naïve and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.	Double-blind 3-DAA (Treatment-Experienced) n=141 Participants Participants who were treatment-experienced and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.
Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: From the end of treatment through 24 weeks after the last dose of active study drug

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.

Outcome measures

Outcome measures
Measure	Double-blind 3-DAA (Treatment-Naïve) n=183 Participants Participants who were treatment-naïve and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.	Double-blind 3-DAA (Treatment-Experienced) n=141 Participants Participants who were treatment-experienced and received double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.
Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.7

Adverse Events

Double-blind 3-DAA

Serious events: 7 serious events

Other events: 72 other events

Deaths: 0 deaths

Double-blind Placebo

Serious events: 2 serious events

Other events: 61 other events

Deaths: 0 deaths

Open-label 3-DAA

Serious events: 5 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Double-blind 3-DAA n=325 participants at risk Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.	Double-blind Placebo n=325 participants at risk Double-blind placebo for 12 weeks.	Open-label 3-DAA n=324 participants at risk Open-label 3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	2.2% 7/325 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).	5.5% 18/325 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).	2.2% 7/324 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	10.2% 33/325 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).	8.9% 29/325 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).	9.6% 31/324 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).
Nervous system disorders DIZZINESS	5.2% 17/325 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).	3.1% 10/325 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).	2.8% 9/324 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).
Nervous system disorders HEADACHE	6.2% 20/325 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).	4.0% 13/325 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).	4.0% 13/324 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).

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