Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Human Immunodeficiency Virus; Hepatitis C

Treatments: Drug: RBV; Drug: SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01667731

GS-US-334-0123

Details and patient eligibility

About

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to provide written informed consent

• Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection

• HCV RNA > 1 x 10^4 IU/mL at screening

• Infection with HCV genotype 1, 2 or 3 as determined at screening

• HIV-1 infection confirmed with positive ELISA or Western blot at screening

• Medical records must be sufficient to be categorized on interferon (IFN) eligibility or prior treatment history with PEG/RBV.

• Confirmation of chronic HCV infection

• Ability to determine presence/absence of cirrhosis.

• HIV antiretroviral therapy (ARV) criteria of one of the following:

  • ARV untreated with a CD4 T-cell count > 500 cells/mm^3
  • On a stable, protocol-approved, ARV for > 8 weeks prior to screening with a CD4 T-cell count > 200 cells/mm^3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the screening visit

• Approved HIV antiretroviral medications based on drug interaction studies

• Not been treated with any investigational drug or device within 30 days of the screening visit

• Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV

• Males who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV

• Must be of generally good health as determined by the investigator.

• Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)

Exclusion criteria

• Non-genotype 1/2/3 or mixed genotype at screening
• Genotype 1 with prior treatment for HCV
• Poor control with ARV regimen
• Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
• Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
• A new AIDS-defining condition diagnosed within 30 days prior to screening
• Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to baseline
• Infection with hepatitis B virus (HBV)
• Contraindication to RBV therapy
• Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent > 10 mg/day)
• History of solid organ transplantation or malignancy diagnosed or treated within 5 years
• Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 3 patient groups

SOF+RBV 12 Weeks (GT 2/3, TN)

Experimental group

Description:

Treatment-naive (TN) participants coinfected with HIV-1 and genotype (GT) 2 or genotype 3 HCV infection will receive SOF+RBV for 12 weeks.

Treatment:

Drug: SOF

Drug: RBV

SOF+RBV 24 Weeks (GT 2/3, TE)

Experimental group

Description:

Treatment-experienced (TE) participants coinfected with HIV-1 and genotype 2 or genotype 3 HCV infection will receive SOF+RBV for 24 weeks.

Treatment:

Drug: SOF

Drug: RBV

SOF+RBV 24 Weeks (GT 1, TN)

Experimental group

Description:

Treatment-naive (TN) participants coinfected with HIV-1 and genotype 1 HCV infection will receive SOF+RBV for 24 weeks.

Treatment:

Drug: SOF

Drug: RBV