Trial Outcomes & Findings for Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant (NCT NCT02533934)

Last Updated: 2021-02-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

68 participants

Primary outcome timeframe

Median time from end of treatment was 38.5 months

Results posted on

2021-02-02

Participant Flow

STOP-CO is a multi-center prospective and retrospective, open-label study using sofosbuvir-based DAA therapy to treat HIV/HCV coinfected participants pre- or post-LT.

The study was designed to prospectively assign ledipasvir-sofosbuvir to participants awaiting transplant or ≥1 month post-transplant. During the course of the trials, DAAs became widely available and the standard of care for the target study population. Only 7 participants could be enrolled in the prospective arm of this study with ledipasvir-sofosbuvir. Therefore in 2017 the study was amended to include retrospective participants treated with any sofosbuvir-based therapy after 2014.

Participant milestones

Participant milestones
Measure	Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.	Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
Overall Study STARTED	42	26
Overall Study COMPLETED	42	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant n=42 Participants The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.	Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant n=26 Participants The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.	Total n=68 Participants Total of all reporting groups
Age, Continuous	56.4 years n=99 Participants	57.2 years n=107 Participants	56.6 years n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	4 Participants n=107 Participants	15 Participants n=206 Participants
Sex: Female, Male Male	31 Participants n=99 Participants	22 Participants n=107 Participants	53 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	21 Participants n=99 Participants	11 Participants n=107 Participants	32 Participants n=206 Participants
Race (NIH/OMB) White	13 Participants n=99 Participants	11 Participants n=107 Participants	24 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=99 Participants	3 Participants n=107 Participants	9 Participants n=206 Participants
Region of Enrollment United States	42 participants n=99 Participants	26 participants n=107 Participants	68 participants n=206 Participants

PRIMARY outcome

Timeframe: Median time from end of treatment was 38.5 months

Outcome measures

Outcome measures
Measure	Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant n=42 Participants The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.	Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant n=26 Participants The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
Number of Participants With Sustained Virologic Response (SVR)	38 Participants	25 Participants

SECONDARY outcome

Timeframe: Median months from baseline to last MELD measurement is 48 months

Population: participants treated pre-liver transplant, who had MELD scores available pre and post treatment

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.

Outcome measures

Outcome measures
Measure	Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant n=33 Participants The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.	Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
Reversal in Decompensation Participants who MELD score improved from baseline	19 Participants	—
Reversal in Decompensation Participants who MELD score worsened from baseline	11 Participants	—
Reversal in Decompensation Participants who MELD score was unchanged	3 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant n=42 Participants The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.	Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant n=26 Participants The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
Change in Liver Fibrosis Change in AST to platelet ratio index (APRI)	-0.71 units on a scale Interval -1.63 to -0.37	-0.72 units on a scale Interval -1.41 to -0.39
Change in Liver Fibrosis Change in Fibrosis-4 (FIB-4)	-2.76 units on a scale Interval -4.78 to -0.47	-1.06 units on a scale Interval -2.04 to -0.2

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant n=42 Participants The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.	Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant n=26 Participants The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
HIV Viral Breakthrough or Relapse	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Median months from baseline to last ALT measurement is 41 months

Change in ALT after sofosbuvir based DAA therapy

Outcome measures

Outcome measures
Measure	Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant n=40 Participants The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.	Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant n=26 Participants The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
Number of Subjects Treated With Sofosbuvir-based DAA Therapy Who Had Alanine Aminotransferase (ALT) Normalization Post Treatment (Normal Reference Range: 7 - 55 IU/L)	31 Participants	20 Participants

Adverse Events

Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant

Serious events: 18 serious events

Other events: 2 other events

Deaths: 10 deaths

Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant

Serious events: 7 serious events

Other events: 4 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant n=42 participants at risk The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.	Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant n=26 participants at risk The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study.
General disorders Nausea	0.00% 0/42 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.	3.8% 1/26 • Number of events 1 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.
General disorders Fatigue	0.00% 0/42 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.	3.8% 1/26 • Number of events 1 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.
General disorders Vomiting	0.00% 0/42 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.	3.8% 1/26 • Number of events 1 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.
General disorders Headaches	0.00% 0/42 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.	3.8% 1/26 • Number of events 1 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.
Blood and lymphatic system disorders Leukopenia	0.00% 0/42 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.	3.8% 1/26 • Number of events 1 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.
Hepatobiliary disorders Hyperbilirubiinemia	2.4% 1/42 • Number of events 1 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.	0.00% 0/26 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.
Blood and lymphatic system disorders Hyperglycemia	2.4% 1/42 • Number of events 1 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.	0.00% 0/26 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.
Respiratory, thoracic and mediastinal disorders Bronchitis	2.4% 1/42 • Number of events 1 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.	0.00% 0/26 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.
Respiratory, thoracic and mediastinal disorders Pnemonia	2.4% 1/42 • Number of events 1 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.	0.00% 0/26 • Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time. All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.

Additional Information

Rodney Rogers

University of California San Francisco

Phone: +14155951226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place