Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C

AbbVie394 enrolled

Overview

This study seeks to provide evidence of the effectiveness and obtain patient reported outcomes (PRO) and work productivity data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), +/- dasabuvir (DSV), +/- ribavirin (RBV) in chronic hepatitis C virus infected patients.

Study Type

OBSERVATIONAL

Enrollment

394

Conditions

Chronic Hepatitis C

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label. * If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy). * Patients must voluntarily sign and date a patient authorization to use and/or disclose his/her anonymized health data prior to inclusion into the study. * Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial Exclusion Criteria: -None

Outcomes

Primary Outcomes

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.

Time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Secondary Outcomes

Percentage of Participants Achieving Virological Response at End of Treatment

Virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.

Time frame: End of treatment (week 12 or 24 depending on the treatment regimen)

Percentage of Participants With Relapse

Relapse was defined as participants with a virologic response (VR; HCV RNA \< 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.

Time frame: End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.

Percentage of Participants With Breakthrough

Breakthrough was defined as at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.

Time frame: 12 or 24 weeks (depending on the treatment regimen)

Percentage of Participants With a Rapid Virological Response at Week 4

Rapid virological response at week 4 (RVR4) was defined as participants with HCV RNA \< 50 IU/mL at week 4. Due to the non-interventional character of the study, many participants did not have an HCV RNA assessed at treatment week 4 since this is not generally recommended in the label. Participants with missing data at the RVR4 time point were considered as virological failures.

Time frame: Week 4

Data from ClinicalTrials.gov

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Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24)

Sustained virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.

Time frame: 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)

Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12)

Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. The core population with sufficient follow-up data regarding SVR12 included all core population participants who * had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE regimen, * or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline * or had HCV RNA \< 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE regimen due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.

Time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment

SVR12 non-response was categorized according to the following: * Relapse, defined as HCV RNA \< 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened); * Death; * Premature treatment discontinuation with no on-treatment virological failure; * Missing SVR12 data and/or none of the above criteria.

Time frame: 12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Assigned Treatment Regimen

Treatment regimen was assigned by the physician according to local practice and label. Participants could receive two direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir and ombitasvir) plus ribavirin (RBV) for either 12 or 24 weeks, or three DAAs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks.

Time frame: Baseline

Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA

Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)

Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen

Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV

Adherence to study treatment was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration)

Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen

Number of Participants With Comorbidities

Time frame: Baseline

Number of Participants Who Received Concomitant Medications

Concomitant medication other than for chromic hepatitis C used from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose.

Time frame: From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen

Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies

Time frame: From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.

Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score

The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS). Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status.