Clinical trial NCT02219503: A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
Official title: An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Infection
Compensated Cirrhosis
Keywords: Hepatitis C
Chronic Hepatitis C
Compensated Cirrhosis
Cirrhotic
Hepatitis C Genotype 1b
Hepatitis C Virus
Interferon-Free
Child Pugh A
Ribavirin-Free
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.

Detailed description: This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.

Eligibility criteria: Inclusion Criteria:

1. Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:

   * Positive for anti-HCV antibody (Ab) or HCV RNA \> 1,000 IU/mL at least 6 months before Screening, and positive for HCV RNA and anti-HCV Ab at the time of Screening; or
   * HCV RNA \> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
2. Screening laboratory result indicating HCV genotype 1b-infection.
3. Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)
5. Use of contraindicated medications within 2 weeks of dosing
6. Screening laboratory analyses showing any of the following abnormal laboratory results:

   * Calculated creatinine clearance (using Cockcroft-Gault method) \< 30 mL/min
   * Albumin \< 2.8 g/dL
   * International normalized ratio (INR) \> 1.8. Participants with a known inherited blood disorder and INR \> 1.8 may be enrolled with permission of the AbbVie Study Designated Physician.
   * Hemoglobin \< 10 g/dL
   * Platelets \< 25,000 cells per mm3
   * Total bilirubin \> 3.0 mg/dL

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
timeFrame: Post-treatment Day 1 to Post-treatment Week 12
Secondary outcomes:
measure: Percentage of Participants With On-Treatment Virologic Failure
timeFrame: Day 1 through Week 12
measure: Percentage of Participants With Post-Treatment Relapse
timeFrame: Post-treatment Day 1 to Post-treatment Week 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Roger Trinh, MD
role: STUDY_DIRECTOR
References:
citation: Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, Elkhashab M, Bernstein DE, Younes Z, Reindollar RW, Larsen L, Fu B, Howieson K, Polepally AR, Pangerl A, Shulman NS, Poordad F. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol. 2016 Feb;64(2):301-307. doi: 10.1016/j.jhep.2015.10.005. Epub 2015 Oct 22.