Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

AbbVie

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus (HCV) Infection; Chronic Hepatitis C

Treatments: Drug: Pegylated interferon (pegIFN); Drug: Ribavirin (RBV); Other: Placebo for ABT-267; Drug: ABT-267

Study type: Interventional

Funder types: Industry

Identifiers

NCT01314261

M12-114

Details and patient eligibility

About

The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.

Full description

The study was a randomized, double blind, placebo controlled study consisting of 2 substudies. In substudy 1, participants received 1 of 3 doses of ABT-267 or placebo + pegIFN/RBV for 12 weeks. In substudy 2, participants received pegIFN/RBV for 36 weeks. Participants were followed for 48 weeks post ABT-267 treatment for evaluation of efficacy and safety.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment naïve participants
• Females must be either postmenopausal for at least 2 years or surgically sterile
• Males must be surgically sterile or practicing specific forms of birth control
• Chronic hepatitis C virus (HCV), genotype-1 infected participants
• Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis

Exclusion criteria

• Pregnant or breastfeeding female
• Use of any medications contraindicated for use with pegylated interferon(pegIFN) or ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever is longer
• Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder
• Current or past clinical evidence of cirrhosis or bridging fibrosis
• Abnormal screening laboratory results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

37 participants in 4 patient groups, including a placebo group

ABT-267 (5 mg) once daily + pegIFN/RBV

Experimental group

Description:

Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.

Treatment:

Drug: ABT-267

Drug: Pegylated interferon (pegIFN)

Drug: Ribavirin (RBV)

ABT-267 (50 mg) once daily + pegIFN/RBV

Experimental group

Description:

Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.

Treatment:

Drug: ABT-267

Drug: Pegylated interferon (pegIFN)

Drug: Ribavirin (RBV)

ABT-267 (200 mg) once daily + pegIFN/RBV

Experimental group

Description:

Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.

Treatment:

Drug: ABT-267

Drug: Pegylated interferon (pegIFN)

Drug: Ribavirin (RBV)

Placebo + pegIFN/RBV

Placebo Comparator group

Description:

Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.

Treatment:

Drug: Pegylated interferon (pegIFN)

Drug: Ribavirin (RBV)

Other: Placebo for ABT-267