Retrospective/Prospective, open-label study using sofosbuvir based DAA therapy to treat HIV/HCV coinfected pre or post liver transplant participants
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Treatment of Hepatitis C with sofosbuvir based HCC therapy
University of California, San Francisco
San Francisco, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins Medical Center
Number of Participants With Sustained Virologic Response (SVR)
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
Time frame: Median time from end of treatment was 38.5 months
Reversal in Decompensation
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.
Time frame: Median months from baseline to last MELD measurement is 48 months
Change in Liver Fibrosis
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.
Time frame: Median months from baseline to last APRI measurement is 41 months Median months from baseline to last FIB-4 measurement is 41 months
HIV Viral Breakthrough or Relapse
Number of participants with a detectable HIV viral load after sofosbuvir-based HCV therapy
Time frame: Median months from baseline to last HIV follow-up is 38 months
Number of Subjects Treated With Sofosbuvir-based DAA Therapy Who Had Alanine Aminotransferase (ALT) Normalization Post Treatment (Normal Reference Range: 7 - 55 IU/L)
Change in ALT after sofosbuvir based DAA therapy
Time frame: Median months from baseline to last ALT measurement is 41 months
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Baltimore, Maryland, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Mt. Sinai Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States