Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant

Phase 4

Completed

Brief Summary: Retrospective/Prospective, open-label study using sofosbuvir based DAA therapy to treat HIV/HCV coinfected pre or post liver transplant participants

Detailed Description: Approximately fifty HIV/HCV coinfected patients with decompensated liver disease will be enrolled in the study. Ten (up to twenty) subjects will be treated with FDC SOF/LDV pre or post liver transplant and followed prospectively. Forty + subjects will be enrolled retrospectively with the intent to capture all patients who have been exposed to sofosbuvir based DAA therapies at participating sites since 1/2014, and to mirror the population being enrolled prospectively.

In addition, participants in the retrospective arm will be contacted to consent to one prospective study visit for liver staging to determine rates of reversal of decompensation, reversal of cirrhosis and improvements in graft survival post treatment, and for future contact by the NIH Clinical Center to assess longer term outcomes when this study ends.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Treatment with Sofosbuvir based HCV Therapy	Harvoni	Prospective and retrospective treatment for HCV

Primary Outcome Measures

Name	Time	Method
Number of Participants With Sustained Virologic Response (SVR)	Median time from end of treatment was 38.5 months	Sustained virologic response (SVR) defined by hepatitis C virus (HCV) RNA less than the lower level limit of quantification (LLOQ) of \<15 IU/ml at a median time of 38.5 months after the end of sofosbuvir-based direct-acting antiviral (DAA) therapy

Secondary Outcome Measures

Name	Time	Method
Reversal in Decompensation	Median months from baseline to last MELD measurement is 48 months	Number of participants with an improved, worsened or unchanged MELD (Model for End-stage Liver Disease) score. A MELD score ranges from 6 to 40. The higher the number, the worse the liver disease.
Change in Liver Fibrosis	Median months from baseline to last APRI measurement is 41 months Median months from baseline to last FIB-4 measurement is 41 months	Change in AST to Platelet Ratio Index (APRI) where negative values indicate improvement in liver fibrosis score and positive values indicate worsening of fibrosis score. There is no upper or lower limit for change. Change in Fibrosis-4 (FIB-4) where negative values indicate improvement in liver fibrosis score and positive values indicate worsening of fibrosis score. There is no upper or lower limit for change.
Number of Subjects Treated With Sofosbuvir-based DAA Therapy Who Had Alanine Aminotransferase (ALT) Normalization Post Treatment (Normal Reference Range: 7 - 55 IU/L)	Median months from baseline to last ALT measurement is 41 months	Change in ALT after sofosbuvir based DAA therapy
HIV Viral Breakthrough or Relapse	Median months from baseline to last HIV follow-up is 38 months	Number of participants with a detectable HIV viral load after sofosbuvir-based HCV therapy

Locations (8): University of California, San Francisco
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San Francisco, California, United States
National Institutes of Health Clinical Center
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Bethesda, Maryland, United States
Mt. Sinai Medical Center
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New York, New York, United States
Columbia University
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New York, New York, United States
University of Maryland
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Baltimore, Maryland, United States
Johns Hopkins Medical Center
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Baltimore, Maryland, United States
University of Pennsylvania
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Philadelphia, Pennsylvania, United States
Georgetown University
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Washington, District of Columbia, United States