A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

Chronic Hepatitis C Clinical Trial

Official title:

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783678
• Other study ID #: GS-US-334-0124
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2013
• Last updated: April 15, 2015
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection

• HCV RNA > 10,000 IU/mL at screening

• HCV treatment history:

• Treatment-naive for HCV genotypes 1, 2, 3, or 4, or

• Treatment-experienced for HCV genotypes 2 or 3

• HIV antiretroviral (ARV) criteria:

• On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for > 8 weeks prior to screening, or

• ARV untreated for = 8 weeks prior to screening, with a CD4 T-cell count > 500 cells/mm^3

• Presence or absence of cirrhosis; a liver biopsy may be required

• Healthy according to medical history and physical examination with the exception of HCV and HIV diagnosis

• Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

Exclusion Criteria:

• HCV genotype 1 or 4 with previous HCV treatment

• Poor control with HIV ARV regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing

• A new AIDS-defining condition diagnosed within 30 days prior to screening

• Prior use of any other inhibitor of the HCV NS5B polymerase

• History of any other clinically significant chronic liver disease

• Evidence of or history of decompensated liver disease

• Chronic hepatitis B virus (HBV) infection

• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)

• Chronic use of immunosuppressive agents or immunomodulatory agents

• Clinically relevant drug or alcohol abuse within 12 months of screening

• History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study or not be in the best interest of the participant in the opinion of the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
• RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and = 75 kg = 1200 mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

Australia,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug.	Posttreatment Week 12	No
Primary	Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)	The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.	Up to 24 weeks	No
Secondary	Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.	Posttreatment Weeks 4 and 24	No
Secondary	HCV RNA Change From Baseline at Week 1		Baseline; Week 1	No
Secondary	HCV RNA Change From Baseline at Week 2		Baseline; Week 2	No
Secondary	HCV RNA Change From Baseline at Week 4		Baseline; Week 4	No
Secondary	HCV RNA Change From Baseline at Week 6		Baseline; Week 6	No
Secondary	HCV RNA Change From Baseline at Week 8		Baseline; Week 8	No
Secondary	Percentage of Participants Experiencing Virologic Failure	On-treatment virologic failure was defined as either: Virologic breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while on treatment), or; Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; Nonresponse (HCV RNA persistently = LLOQ through 8 weeks of treatment).; Virologic relapse was defined as confirmed HCV RNA = LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit."	Baseline up to Posttreatment Week 24	No