A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C

NCT02206932 | Withdrawn Phase 4

• 1 other identifier: TMC435HPC2008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir and simeprevir in patients who have both the HIV and hepatitis C (HCV) viruses.

Conditions

Hepatitis C, Chronic; HIV CDC Category A1

Keywords

Hepatitis C; HIV; Simeprevir; Sofosbuvir

Outcome Measures

Primary Outcomes (1)

• SVR12 (HCV RNA <LLOQ, or lower limit of quantification)

  12 weeks after discontinuation of study treatment

Study Arms (1)

Sofosbuvir + Simeprevir

OTHER

Subjects will be enrolled and treated with simeprevir 150 mg and sofosbuvir 400 mg once daily for 12 weeks

Drug: Sofosbuvir + Simeprevir

Interventions

Sofosbuvir + Simeprevir DRUG

Also known as: Sovaldi, Olysio, TMC435

Sofosbuvir + Simeprevir

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide written informed consent
• Male or female, age ≥ 18 years
• Body mass index (BMI) ≥ 18 kg/m2
• HCV RNA ≥ 104 IU/mL at Screening
• HCV genotype 1 at screening or with prior documentation. Any non-definitive genotype results will exclude the subject from study participation
• Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
• Fibrosis determination: Fibrosis of Metavir F3/F4 may be established by one of the following:
• Liver biopsy at any point in time with Metavir score F3/F4, or equivalent on an alternative scale.
• Fibroscan ≥ 9.5 kPA
• FibroSURE: ≥ 0.58
• Liver imaging within 12 months prior to Baseline/Day 1 is required in subjects with known cirrhosis to exclude hepatocellular carcinoma (HCC). Acceptable liver imaging includes ultrasound, CT scan or MRI.
• HCV treatment status of one of the following:
• HCV Treatment-Naive: No prior exposure to any IFN, RBV, or other approved or experimental HCV-specific DAA agents
• i. HCV Treatment-Intolerant: Subjects that discontinued HCV treatment due to development or significant worsening of a treatment related adverse event ii. Null responder: HCV RNA \< 2 log10 decline during first 12 weeks of treatment iii. Partial responder: HCV RNA ≥ 2 log10 decline during first 12 weeks of treatment but stopped therapy due to inadequate virologic response iv. Relapse : Undetectable HCV RNA (HCV RNA \<LLOQ) on treatment, but experienced breakthrough or relapse
• HIV-1 infection as documented by HIV-1 antibody at screening or any time prior to screening

You may not qualify if:

• Hepatic decompensation at any point in time (includes variceal bleeding, hepatic encephalopathy, and ascites)
• HBs Ag +
• Prior HCV treatment with an HCV protease inhibitor or HCV polymerase inhibitor including sofosbuvir
• Other known causes of significant liver disease including chronic or acute hepatitis B, acute hepatitis A, hemochromatosis, or homozygote alpha-1 antitrypsin deficiency.
• Serious illness including malignancy within 24 weeks prior to study entry, or other chronic medical conditions that in the opinion of the site investigator may preclude completion of the protocol.
• Presence of active or acute AIDS-defining opportunistic infections within 12 weeks prior to study entry.
• Use of any prohibited concomitant medications
• Child-Pugh Score 6.2.2 Pre-entry\>6

Sponsors & Collaborators

• University of California, San Francisco: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

San Francisco General Hospital, University of California, San Francisco

San Francisco, California, 94110, United States

Location

Related Publications (3)

• Kirk GD, Mehta SH, Astemborski J, Galai N, Washington J, Higgins Y, Balagopal A, Thomas DL. HIV, age, and the severity of hepatitis C virus-related liver disease: a cohort study. Ann Intern Med. 2013 May 7;158(9):658-66. doi: 10.7326/0003-4819-158-9-201305070-00604.

  PMID: 23440167 BACKGROUND

• Sulkowski MS, Mehta SH, Torbenson MS, Higgins Y, Brinkley SC, de Oca RM, Moore RD, Afdhal NH, Thomas DL. Rapid fibrosis progression among HIV/hepatitis C virus-co-infected adults. AIDS. 2007 Oct 18;21(16):2209-16. doi: 10.1097/QAD.0b013e3282f10de9.

  PMID: 18090048 BACKGROUND

• Osinusi A, Meissner EG, Lee YJ, Bon D, Heytens L, Nelson A, Sneller M, Kohli A, Barrett L, Proschan M, Herrmann E, Shivakumar B, Gu W, Kwan R, Teferi G, Talwani R, Silk R, Kotb C, Wroblewski S, Fishbein D, Dewar R, Highbarger H, Zhang X, Kleiner D, Wood BJ, Chavez J, Symonds WT, Subramanian M, McHutchison J, Polis MA, Fauci AS, Masur H, Kottilil S. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. JAMA. 2013 Aug 28;310(8):804-11. doi: 10.1001/jama.2013.109309.

  PMID: 23982366 BACKGROUND

Related Links

• Positive Health Program, San Francisco General Hospital/University of California, San Francisco

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Sofosbuvir; Simeprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Anne Luetkemeyer, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 1, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 13, 2019

Record last verified: 2019-06

Locations

US (1)