Trial Outcomes & Findings for deLIVER: Direct Acting Antiviral Effects on the Liver (NCT NCT02938013)
NCT ID: NCT02938013
Last Updated: 2022-02-24
Results Overview
Estimate the total number of HCV-infected Hepatocytes (virus burden) for each participant between pre-treatment liver biopsy and post treatment liver biopsy samples using HCV Quantitative real time PCR. Comparison of total number of HCV-infected Hepatocytes (virus burden) were reported between HCV mono infection and co infection groups.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
Pre-treatment, Day 7
Results posted on
2022-02-24
Participant Flow
Participant milestones
| Measure |
Group A
Monoinfected: Sofosbuvir/Velpatasvir/Voxilaprevir SOF/VEL/VOX days 0-7 Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL days 8 (week 2) through 84 (week 12). Post-treatment follow up through week 12.
|
Group B
Monoinfected: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
Group C
HIV/HCV Co-infection: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
deLIVER: Direct Acting Antiviral Effects on the Liver
Baseline characteristics by cohort
| Measure |
Group A
n=5 Participants
Monoinfected: Sofosbuvir/Velpatasvir/Voxilaprevir SOF/VEL/VOX days 0-7 Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL days 8 (week 2) through 84 (week 12). Post-treatment follow up through week 12.
|
Group B
n=5 Participants
Monoinfected: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
Group C
n=5 Participants
HIV/HCV Co-infection: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
47 years
n=7 Participants
|
54.6 years
n=5 Participants
|
50.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment, Day 7Population: Overall number analyzed is the total hepatocytes analyzed in specific arms but numbers in rows represent only HCV positive Hepatocytes
Estimate the total number of HCV-infected Hepatocytes (virus burden) for each participant between pre-treatment liver biopsy and post treatment liver biopsy samples using HCV Quantitative real time PCR. Comparison of total number of HCV-infected Hepatocytes (virus burden) were reported between HCV mono infection and co infection groups.
Outcome measures
| Measure |
Group A
n=3220 Hepatocytes
Monoinfected: Sofosbuvir/Velpatasvir/Voxilaprevir SOF/VEL/VOX days 0-7 Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL days 8 (week 2) through 84 (week 12). Post-treatment follow up through week 12.
|
Group B
n=3340 Hepatocytes
Monoinfected: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
Group C
n=3463 Hepatocytes
HIV/HCV Co-infection: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
|---|---|---|---|
|
Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C)pos trea
|
2 Hepatocytes
|
5 Hepatocytes
|
7 Hepatocytes
|
|
Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C)pre trea
|
45 Hepatocytes
|
16 Hepatocytes
|
290 Hepatocytes
|
|
Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)pos trea
|
0 Hepatocytes
|
1 Hepatocytes
|
3 Hepatocytes
|
|
Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)pretreat
|
18 Hepatocytes
|
212 Hepatocytes
|
216 Hepatocytes
|
|
Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)postreat
|
2 Hepatocytes
|
9 Hepatocytes
|
24 Hepatocytes
|
|
Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)pre trea
|
109 Hepatocytes
|
24 Hepatocytes
|
13 Hepatocytes
|
|
Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)pos trea
|
3 Hepatocytes
|
1 Hepatocytes
|
0 Hepatocytes
|
|
Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)pretre
|
126 Hepatocytes
|
4 Hepatocytes
|
74 Hepatocytes
|
|
Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)postre
|
18 Hepatocytes
|
1 Hepatocytes
|
12 Hepatocytes
|
|
Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)pre trea
|
53 Hepatocytes
|
11 Hepatocytes
|
33 Hepatocytes
|
SECONDARY outcome
Timeframe: Pre-treatment, up to 1 weekPopulation: Decline plasma levels of HCV RNA from each participant obtained over the first week.
During one week after treatment with direct-acting antivirals, the decline from the baseline plasma HCV RNA levels observed for each individual participant using HCV Quantitative real time PCR. The level of HCV RNA decline compared to those treated with Sofosbuvir/Velpatasvir (SOF/VEL) vs Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) and between HCV mono infection and HIV/HCV co infection groups.
Outcome measures
| Measure |
Group A
n=5 Participants
Monoinfected: Sofosbuvir/Velpatasvir/Voxilaprevir SOF/VEL/VOX days 0-7 Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL days 8 (week 2) through 84 (week 12). Post-treatment follow up through week 12.
|
Group B
n=5 Participants
Monoinfected: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
Group C
n=5 Participants
HIV/HCV Co-infection: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
|---|---|---|---|
|
Reduction Over the First Week in Plasma HCV RNA
Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C)
|
631 IU/ml
Interval 0.0 to 1945000.0
|
2240 IU/ml
Interval 0.0 to 1760000.0
|
14817.5 IU/ml
Interval 0.0 to 32700000.0
|
|
Reduction Over the First Week in Plasma HCV RNA
Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)
|
217.75 IU/ml
Interval 0.0 to 1080000.0
|
884.75 IU/ml
Interval 0.0 to 478500.0
|
635.5 IU/ml
Interval 0.0 to 1690000.0
|
|
Reduction Over the First Week in Plasma HCV RNA
Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)
|
1029.75 IU/ml
Interval 0.0 to 555500.0
|
1348500 IU/ml
Interval 0.0 to 84300000.0
|
5327.5 IU/ml
Interval 0.0 to 33050000.0
|
|
Reduction Over the First Week in Plasma HCV RNA
Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)
|
6617.5 IU/ml
Interval 0.0 to 14950000.0
|
551.5 IU/ml
Interval 0.0 to 1020000.0
|
65075 IU/ml
Interval 0.0 to 4675000.0
|
|
Reduction Over the First Week in Plasma HCV RNA
Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)
|
2506.5 IU/ml
Interval 0.0 to 4170000.0
|
627.5 IU/ml
Interval 0.0 to 1680000.0
|
12992.5 IU/ml
Interval 0.0 to 2990000.0
|
SECONDARY outcome
Timeframe: Pre-treatment, up to 1 weekPopulation: Total number of hepatocytes that express interferon-stimulated genes (ISGs) between pre and post treatment
Total number of hepatocytes that express interferon-stimulated genes (ISGs) were estimated using Quantitative real time PCR for each participant on pre-treatment and post treatment liver biopsy samples. Comparison of total number of hepatocytes that express interferon-stimulated genes (ISGs) were reported between HCV mono infection and co infection groups.
Outcome measures
| Measure |
Group A
n=904 Hepatocytes
Monoinfected: Sofosbuvir/Velpatasvir/Voxilaprevir SOF/VEL/VOX days 0-7 Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL days 8 (week 2) through 84 (week 12). Post-treatment follow up through week 12.
|
Group B
n=912 Hepatocytes
Monoinfected: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
Group C
n=904 Hepatocytes
HIV/HCV Co-infection: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
|---|---|---|---|
|
Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Pre Treatment
|
14 ISG positive hepatocytes
|
71 ISG positive hepatocytes
|
41 ISG positive hepatocytes
|
|
Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Post Treatment
|
8 ISG positive hepatocytes
|
68 ISG positive hepatocytes
|
68 ISG positive hepatocytes
|
|
Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C) Pre Treatment
|
57 ISG positive hepatocytes
|
36 ISG positive hepatocytes
|
39 ISG positive hepatocytes
|
|
Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C) Post Treatment
|
62 ISG positive hepatocytes
|
24 ISG positive hepatocytes
|
40 ISG positive hepatocytes
|
|
Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C) Pre Treatment
|
78 ISG positive hepatocytes
|
66 ISG positive hepatocytes
|
55 ISG positive hepatocytes
|
|
Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C) Post Treatment
|
83 ISG positive hepatocytes
|
46 ISG positive hepatocytes
|
57 ISG positive hepatocytes
|
|
Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C) Pre Treatment
|
71 ISG positive hepatocytes
|
49 ISG positive hepatocytes
|
36 ISG positive hepatocytes
|
|
Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C) Post Treatment
|
71 ISG positive hepatocytes
|
27 ISG positive hepatocytes
|
63 ISG positive hepatocytes
|
|
Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C) Pre Treatment
|
79 ISG positive hepatocytes
|
67 ISG positive hepatocytes
|
34 ISG positive hepatocytes
|
|
Total Number of HCV-infected Hepatocytes That Express Interferon-stimulated Genes (ISGs) Within the First Week of DAA Therapy Using Single Cell Laser Micro Dissection (scLCM).
Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C) Post Treatment
|
72 ISG positive hepatocytes
|
66 ISG positive hepatocytes
|
42 ISG positive hepatocytes
|
SECONDARY outcome
Timeframe: Pre-treatment, after first weekPopulation: Amount of HCV RNA levels from individual hepatocytes for each participant obtained at pre-treatment and post treatment.
The HCV RNA levels (viral burden) from each infected hepatocytes were measured using Quantitative Real-Time Polymerase Chain Reaction (PCR) from each participants at pre-treatment and post-treatment. The level of HCV RNA (viral burden) decline were reported from intracellular hepatocytes and compared to those treated with Sofosbuvir/Velpatasvir (SOF/VEL) vs Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) and between HCV mono infection and HIV/HCV co infection groups.
Outcome measures
| Measure |
Group A
n=5 Participants
Monoinfected: Sofosbuvir/Velpatasvir/Voxilaprevir SOF/VEL/VOX days 0-7 Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL days 8 (week 2) through 84 (week 12). Post-treatment follow up through week 12.
|
Group B
n=5 Participants
Monoinfected: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
Group C
n=5 Participants
HIV/HCV Co-infection: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
|---|---|---|---|
|
Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Pre treat
|
8.61 International unit (IU) per hepatocyte
Interval 0.94 to 51.6
|
7.57 International unit (IU) per hepatocyte
Interval 0.1 to 41.1
|
32.7 International unit (IU) per hepatocyte
Interval 0.03 to 789.0
|
|
Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
Participant 1 (Group A) Participant 1 (Group B) Participant 1 (Group C) Post treat
|
20.91 International unit (IU) per hepatocyte
Interval 10.47 to 29.7
|
2.83 International unit (IU) per hepatocyte
Interval 1.52 to 8.16
|
37.8 International unit (IU) per hepatocyte
Interval 3.39 to 274.8
|
|
Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)Pre treat
|
19.74 International unit (IU) per hepatocyte
Interval 1.41 to 231.9
|
11.04 International unit (IU) per hepatocyte
Interval 5.94 to 54.6
|
18.36 International unit (IU) per hepatocyte
Interval 8.31 to 80.4
|
|
Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
Participant 2 (Group A) Participant 2 (Group B) Participant 2 (Group C)Post treat
|
0 International unit (IU) per hepatocyte
Interval 0.0 to 0.0
|
12.93 International unit (IU) per hepatocyte
Interval 12.93 to 12.93
|
8.16 International unit (IU) per hepatocyte
Interval 2.89 to 17.16
|
|
Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)Pre treat
|
10.35 International unit (IU) per hepatocyte
Interval 3.57 to 192.9
|
27.18 International unit (IU) per hepatocyte
Interval 1.37 to 336.0
|
30 International unit (IU) per hepatocyte
Interval 0.08 to 1584.0
|
|
Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
Participant 3 (Group A) Participant 3 (Group B) Participant 3 (Group C)Post treat
|
14.76 International unit (IU) per hepatocyte
Interval 6.48 to 23.0
|
9.25 International unit (IU) per hepatocyte
Interval 3.21 to 47.1
|
15.72 International unit (IU) per hepatocyte
Interval 2.92 to 42.0
|
|
Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)Pre treat
|
29.25 International unit (IU) per hepatocyte
Interval 1.0 to 187.2
|
3.45 International unit (IU) per hepatocyte
Interval 1.0 to 67.5
|
14.25 International unit (IU) per hepatocyte
Interval 1.0 to 72.0
|
|
Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
Participant 4 (Group A) Participant 4 (Group B) Participant 4 (Group C)Post treat
|
9.15 International unit (IU) per hepatocyte
Interval 6.54 to 17.4
|
0 International unit (IU) per hepatocyte
Interval 0.0 to 0.0
|
0 International unit (IU) per hepatocyte
Interval 0.0 to 0.0
|
|
Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)Pre treat
|
15.3 International unit (IU) per hepatocyte
Interval 0.15 to 738.0
|
2.36 International unit (IU) per hepatocyte
Interval 1.17 to 16.2
|
5.49 International unit (IU) per hepatocyte
Interval 0.008 to 33.9
|
|
Amount of HCV RNA Per Infected Hepatocyte Using Single Cell Laser Micro Dissection (scLCM) on Liver Biopsy Specimens, Obtained Just Prior to Treatment Initiation (Pre-treatment), and After the First Week of DAA Therapy.
Participant 5 (Group A) Participant 5 (Group B) Participant 5 (Group C)Post treat
|
14.55 International unit (IU) per hepatocyte
Interval 2.0 to 130.5
|
2.27 International unit (IU) per hepatocyte
Interval 2.27 to 2.27
|
4.09 International unit (IU) per hepatocyte
Interval 1.75 to 23.94
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=5 participants at risk
Monoinfected: Sofosbuvir/Velpatasvir/Voxilaprevir SOF/VEL/VOX days 0-7 Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL days 8 (week 2) through 84 (week 12). Post-treatment follow up through week 12.
|
Group B
n=5 participants at risk
Monoinfected: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
Group C
n=5 participants at risk
HIV/HCV Co-infection: Sofosbuvir/Velpatasvir (SOF/VEL) days 0 through 7 and Paired liver biopsy at days 0 and 7 (cohort 1) or days 0 and 4 (cohort 2). SOF/VEL on day 8 (week 2) through 84 (week 12) . Post-Treatment follow up through week 12.
|
|---|---|---|---|
|
Gastrointestinal disorders
Fatigue
|
20.0%
1/5 • Number of events 3 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 2 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
20.0%
1/5 • Number of events 1 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
20.0%
1/5 • Number of events 1 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
20.0%
1/5 • Number of events 1 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
20.0%
1/5 • Number of events 1 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
20.0%
1/5 • Number of events 1 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
|
General disorders
Akathisia
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
20.0%
1/5 • Number of events 1 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
20.0%
1/5 • Number of events 1 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
20.0%
1/5 • Number of events 1 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • Number of events 2 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
20.0%
1/5 • Number of events 1 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
0.00%
0/5 • 24 weeks
adverse events were systematically assessed days 0-7, and week 2 and 4 study visits and as needed. Serious adverse events were systematically assessed at all follow-up visits and as needed.
|
Additional Information
Dr. Mark Sulkowski
Johns Hopkins University School of Medicine
Phone: 443-997-1900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place