Clinical trial NCT02803138: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C
Official title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C - An Observational Study in Israel (CITRINE STUDY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Ombitasvir/paritaprevir/ritonavir ± dasabuvir
Sustained Virological Response
Observational Study
Chronic Hepatitis C genotype 1
Chronic Hepatitis C genotype 4
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with chronic hepatitis C virus infection, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin.

Brief summary: The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Israel in a clinical practice patient population.

Detailed description: This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Israel. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. Adults chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post-treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment \[SVR12\] and sustained virologic response 24 weeks after the end of treatment \[SVR24\]).

Eligibility criteria: * Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
* If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
* Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
* Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial

Exclusion Criteria:

- None

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug
Secondary outcomes:
measure: Percentage of Participants With Virologic Response at End of Treatment (EoT)
timeFrame: Up to 24 weeks
measure: Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment
timeFrame: 12 weeks (at least 70 days) after the last actual dose of study drug
measure: Percentage of Participants With Relapse
timeFrame: Up to 48 weeks after the last actual dose of study drug
measure: Percentage of Participants With Viral Breakthrough
timeFrame: Up to 24 weeks
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: 12 weeks after the last actual dose of study drug
measure: Percentage of Participants Meeting Relapse Criteria
timeFrame: 12 weeks after the last actual dose of study drug
measure: Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
timeFrame: 12 weeks after the last actual dose of study drug
measure: Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria
timeFrame: 12 weeks after the last actual dose of study drug
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center /ID# 169357
state: HaDarom
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 153696
state: Tel-Aviv
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 158648
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Ctr /ID# 153693
state: Tel-Aviv
city: Afula
country: Israel
facility: Ha'Emek Medical Center /ID# 153695
city: Be'er Sheva
country: Israel
facility: Soroka Medical Ctr /ID# 153697
city: Be'er Ya'akov
country: Israel
facility: Assaf Harofeh Medical Center /ID# 153708
city: Gush Dan
country: Israel
facility: Maccabi Health Services /ID# 158647
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center /ID# 153702
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 153694
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 153700
city: Haifa
country: Israel
facility: The Lady Davis Carmel MC /ID# 153692
city: Holon
country: Israel
facility: The Edith Wolfson Medical Cent /ID# 153706
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 153699
city: Jerusalem
country: Israel
facility: Hadassah /ID# 153701
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 153698
city: Nahariya
country: Israel
facility: Western Galilee Medical Center /ID# 153705
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 153707
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.