Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV

NCT01878799 | Completed Phase 2 Results

• 2 other identifiers: 13015913-I-0159
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Present treatment for hepatitis C includes the use of a weekly injection and two different pills. This treatment is associated with serious side effects. Drugs that can be taken by mouth and cure HCV infection without serious side effects would be a great help to the large number of people infected with HCV. GS-7977 and GS-5885 are new medications being developed to treat the hepatitis C virus (HCV) infection. They are still being researched and are not approved by the Food and Drug Administration. They are being developed as treatment for hepatitis C as a single pill taken once a day. Objectives: \- To determine whether a combination of the two study drugs can safely and effectively treat HCV infection in people with HIV infection and who do not have cirrhosis of the liver. Eligibility: \- Individuals who have HIV infection and have liver disease caused by infection with HCV. Design:

• Participants will be screened with a physical exam and medical history. Blood samples will be collected. Urine samples will be collected from participants who might become pregnant. If a participant has not had a liver biopsy in the past 3 years, one will be required.
• Participants will take one pill daily for 12 weeks. This pill will be a combination of the two study drugs.
• Treatment will be monitored with frequent clinic visits and blood tests over a total of 60 weeks.

Conditions

Hepatitis C; HIV

Keywords

Direct Acting Antiviral; Treatment Naive; Interferon Sparing; Ribavirin Sparing

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Achieved SVR12 (HCV RNA <LLOQ 12 Weeks After Completion of Treatment)

  The primary end point was sustained virologic response \[plasma HCV RNA level \<12 IU/mL by real-time HCV assay (Abbott)\] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study.

  12 weeks after completion of treatment

Study Arms (1)

HIV

EXPERIMENTAL

Subjects with HIV and HCV

Drug: GS-7977/GS- 5885 FDC

Interventions

GS-7977/GS- 5885 FDC DRUG

The GS-7977/GS-5885 FDC product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor and will be given for 12 weeks.

HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eighteen years of age or older at screening.
• HCV treatment-naive, as defined as no prior exposure to any IFN, RBV, or other approved or experimental HCV-specific direct-acting antiviral agent.
• Participants must be willing to practice either:
• Abstinence from sexual intercourse or
• At least 2 forms of contraception including one barrier method from 2 weeks prior to Day 0 through 30 days after the last dose is received.
• i. Female partners of male study subjects may rely upon hormonal contraception as one of the 2 methods; however female study subjects may not.
• Chronic hepatitis C infection defined as one of the following:
• Positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening, and positive for HCV RNA and anti-HCV antibody at the time of screening or
• Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of chronic hepatitis C disease, such as the presence of fibrosis).
• HIV treatment status:
• Documented HIV infection, ARV untreated for \> 8 weeks preceding dosing and having either:
• a CD4 T-cell count greater than or equal to 500 cells/mm3 within 8 weeks of Day 0 or
• an HIV viral load less than 500 copies/mL with a stable CD4 count for at least 3 months.
• Documented HIV infection on a stable, protocol-approved, ARV regimen for greater than or equal to 8 weeks prior to dosing and is expected to continue the current ARV regimen through the end of study with all of the following:
• a CD4 T-cell count \> 100 cells/mm3

You may not qualify if:

• Current or prior history of any of the following:
• Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
• Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
• Poor venous access interfering with required study blood collection.
• Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
• Solid organ transplantation.
• Significant pulmonary disease, significant cardiac disease or porphyria.
• Unstable psychiatric disease (Subjects with psychiatric illness that is well-controlled on a stable treatment regimen or currently not requiring medication may be included).
• Any malignancy or its treatment that in the opinion of the PI may cause ongoing interference with host immunity; subjects under evaluation for malignancy are not eligible.
• Significant drug allergy (such as anaphylaxis or hepatotoxicity).
• Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis).
• Patients with renal impairment or uncontrolled medical problems that could place them at high risk for developing renal impairment.
• Positive test at screening for either HBsAg or quantifiable HBV DNA (completed only if necessary to rule out chronic HBV)
• Current use of non-protocol approved ARVs.
• A new AIDS-defining condition diagnosed within 30 days prior to screening or active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to Day 0.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (5)

• Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. doi: 10.1056/NEJM199908193410802.

  PMID: 10451460 BACKGROUND

• Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14. doi: 10.7326/0003-4819-144-10-200605160-00004.

  PMID: 16702586 BACKGROUND

• Kim WR. The burden of hepatitis C in the United States. Hepatology. 2002 Nov;36(5 Suppl 1):S30-4. doi: 10.1053/jhep.2002.36791.

  PMID: 12407574 BACKGROUND

• Townsend K, Petersen T, Gordon LA, Kohli A, Nelson A, Seamon C, Gross C, Tang L, Osinusi A, Polis MA, Masur H, Kottilil S. Effect of HIV co-infection on adherence to a 12-week regimen of hepatitis C virus therapy with ledipasvir and sofosbuvir. AIDS. 2016 Jan;30(2):261-6. doi: 10.1097/QAD.0000000000000903.

  PMID: 26691547 DERIVED

• Osinusi A, Townsend K, Kohli A, Nelson A, Seamon C, Meissner EG, Bon D, Silk R, Gross C, Price A, Sajadi M, Sidharthan S, Sims Z, Herrmann E, Hogan J, Teferi G, Talwani R, Proschan M, Jenkins V, Kleiner DE, Wood BJ, Subramanian GM, Pang PS, McHutchison JG, Polis MA, Fauci AS, Masur H, Kottilil S. Virologic response following combined ledipasvir and sofosbuvir administration in patients with HCV genotype 1 and HIV co-infection. JAMA. 2015 Mar 24-31;313(12):1232-9. doi: 10.1001/jama.2015.1373.

  PMID: 25706232 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Shyam Kottilil
• Organization: National Institute of Allergy and Infectious Diseases

skottilil@niaid.nih.gov

+1 301 435 0936

Study Officials

• Shyamasundaran Kottilil, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 17, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 15, 2016
• Results First Posted: September 15, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)