Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary

AbbVie244 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

244

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 chronic hepatitis C (CHC), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin (PTV/r+OBV±DSV±RBV) according to standard of care and in line with the current local label. * If RBV is co-administered with the PTV/r+OBV±DSV±RBV, 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 Subject Information Form and Informed Consent Form prior to inclusion into the study. * Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial. * Patient has been started on PTV/r+OBV±DSV±RBV therapy no more than one (1) month prior to the study enrollment. 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. Participants with missing HCV RNA were counted as virological failure.

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 With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)

Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug. The Core population with sufficient follow-up data regarding SVR24 included all core population participants who * had evaluable HCV RNA data ≥ 126 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 ≥ 126 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: 24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)

Percentage of Participants Achieving Virological Response at End of Treatment

Virologic response was 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.

Data from ClinicalTrials.gov

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Number 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 in Each Non-response Category 12 Weeks Post-treatment

SVR12 non-response was categorized according to the following: * On-treatment virologic failure (breakthrough \[at least one documented HCV RNA \< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment\] or failure to suppress \[each measured on-treatment HCV RNA value ≥ 50 IU/mL\]); * 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 virologic failure; * None of the above criteria or missing SVR12 data

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

Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category

Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration) \* 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir.

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

Percentage of Participants With Adherence to Ribavirin by Adherence Category

Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as: Cumulative dose taken / (initial prescribed dose \* planned duration) \* 100

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

Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days

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

Number of Participants Who Received Concomitant Medications

Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir 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 (16 or 28 weeks depending on the treatment regimen)

Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS 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). The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The higher the score the better the health status.