Hepatitis C Virus Infection
Conditions
Keywords
Sickle Cell Disease, Gilead, Hepatitis C
Brief summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).
Interventions
DRUGLDV/SOF
90/400 mg fixed dose combination (FDC) tablet administered orally once daily
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Chronic genotype 1 or 4 infected patients with sickle cell disease * HCV RNA ≥ 1,000 IU/mL at screening * Cirrhosis determination by transient elastography * Screening laboratory values within defined thresholds * Use of two effective contraception methods if female of childbearing potential or sexually active male Key
Exclusion criteria
* Pregnant or nursing female * Co-infection with HIV or hepatitis B virus (HBV) * Current or prior history of clinical hepatic decompensation * Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers) * History of clinically significant illness or any other medical disorder that may interfere with treatment, assessment or compliance with the protocol Note: Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | Posttreatment Week 12 | SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 24 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCV RNA Change From Baseline | Up to 24 weeks | — |
| Percentage of Participants With Virologic Failure | Up to Posttreatment Week 12 | Virologic failure was defined as * On-treatment virologic failure * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment, * \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse) * Relapse * HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement |
| Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) | Posttreatment Week 4 | SVR4 was defined as HCV RNA \< the LLOQ 4 weeks following the last dose of study drug. |
| Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score | Weeks 4,12, 24, Posttreatment Weeks 4 and 12 | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability. |
| Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Weeks 4,12, 24, Posttreatment Weeks 4 and 12 | The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life. |
| Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score | Weeks 4,12, 24, Posttreatment Weeks 4 and 12 | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability. |
| Percentage of Participants With HCV RNA < LLOQ on Treatment | Weeks 1, 2, 4, 8,12, 16, 20, and 24 | — |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at 1 study site in the United States. The first participant was screened on 02 March 2015. The last study visit occurred on 18 April 2016.
Participants by arm
| Arm | Count |
|---|---|
| LDV/SOF 12 Weeks Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks | 9 |
| LDV/SOF 24 Weeks Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks | 1 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | LDV/SOF 12 Weeks | Total | LDV/SOF 24 Weeks |
|---|---|---|---|
| Age, Continuous | 43 Years STANDARD_DEVIATION 14.9 | 43 Years STANDARD_DEVIATION 14.1 | 44 Years |
| Cirrhosis status Absence | 9 Participants | 9 Participants | 0 Participants |
| Cirrhosis status Presence | 0 Participants | 1 Participants | 1 Participants |
| HCV genotype Genotype 1a | 5 Participants | 6 Participants | 1 Participants |
| HCV genotype Genotype 1b | 1 Participants | 1 Participants | 0 Participants |
| HCV genotype Genotype 4a/4c/4d | 1 Participants | 1 Participants | 0 Participants |
| HCV genotype Genotype 4f | 1 Participants | 1 Participants | 0 Participants |
| HCV genotype Genotype 4h | 1 Participants | 1 Participants | 0 Participants |
| HCV RNA | 5.8 log10 IU/mL STANDARD_DEVIATION 0.74 | 5.8 log10 IU/mL STANDARD_DEVIATION 0.71 | 6.2 log10 IU/mL |
| HCV RNA Category < 800,000 IU/mL | 6 Participants | 6 Participants | 0 Participants |
| HCV RNA Category ≥ 800,000 IU/mL | 3 Participants | 4 Participants | 1 Participants |
| IL28b Status CC | 1 Participants | 1 Participants | 0 Participants |
| IL28b Status CT | 2 Participants | 3 Participants | 1 Participants |
| IL28b Status TT | 6 Participants | 6 Participants | 0 Participants |
| Prior HCV Treatment Experience With Cirrhosis Treatment-Experienced (Cirrhosis) | 0 Participants | 1 Participants | 1 Participants |
| Prior HCV Treatment Experience With Cirrhosis Treatment-Experienced (Non-cirrhosis) | 2 Participants | 2 Participants | 0 Participants |
| Prior HCV Treatment Experience With Cirrhosis Treatment-Naive (Non-cirrhosis) | 7 Participants | 7 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 10 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 9 Participants | 10 Participants | 1 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 1 |
| other Total, other adverse events | 6 / 9 | 1 / 1 |
| serious Total, serious adverse events | 1 / 9 | 0 / 1 |
Outcome results
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF 12 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0 percentage of participants |
Primary
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Time frame: Posttreatment Week 12
Population: Full Analysis Set: participants who took at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF 12 Weeks | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 88.9 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
Secondary
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life.
Time frame: Weeks 4,12, 24, Posttreatment Weeks 4 and 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Posttreatment Week 4 | 13.0 units on a scale | Standard Deviation 17.2 |
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Week 12 | 9.8 units on a scale | Standard Deviation 17.15 |
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Posttreatment Week 24 | 8.5 units on a scale | Standard Deviation 6.32 |
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Week 4 | 4.6 units on a scale | Standard Deviation 13.86 |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Posttreatment Week 4 | 13.2 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Posttreatment Week 24 | 5.0 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Week 4 | -0.2 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Week 12 | 14.5 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Week 24 | 11.7 units on a scale | — |
Secondary
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability.
Time frame: Weeks 4,12, 24, Posttreatment Weeks 4 and 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score | Week 12 | 3.2 units on a scale | Standard Deviation 8.14 |
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score | Posttreatment Week 4 | 2.2 units on a scale | Standard Deviation 9.69 |
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score | Week 4 | 2.2 units on a scale | Standard Deviation 8.88 |
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score | Posttreatment Week 12 | 2.4 units on a scale | Standard Deviation 6.53 |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score | Posttreatment Week 4 | -4.6 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score | Posttreatment Week 12 | -5.0 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score | Week 4 | -4.7 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score | Week 12 | -3.3 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score | Week 24 | -3.9 units on a scale | — |
Secondary
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability.
Time frame: Weeks 4,12, 24, Posttreatment Weeks 4 and 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score | Week 12 | 2.7 units on a scale | Standard Deviation 7.2 |
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score | Posttreatment Week 4 | 3.5 units on a scale | Standard Deviation 8.26 |
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score | Posttreatment Week 12 | 0.7 units on a scale | Standard Deviation 12.46 |
| LDV/SOF 12 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score | Week 4 | 1.2 units on a scale | Standard Deviation 6.66 |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score | Posttreatment Week 4 | 0.1 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score | Posttreatment Week 12 | 5.5 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score | Week 4 | 8.5 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score | Week 12 | 5.8 units on a scale | — |
| LDV/SOF 24 Weeks | Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score | Week 24 | 2.3 units on a scale | — |
Secondary
HCV RNA Change From Baseline
Time frame: Up to 24 weeks
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF 12 Weeks | HCV RNA Change From Baseline | Change at Week 2 | -3.86 log10 IU/mL | Standard Deviation 1.644 |
| LDV/SOF 12 Weeks | HCV RNA Change From Baseline | Change at Week 1 | -4.20 log10 IU/mL | Standard Deviation 0.543 |
| LDV/SOF 12 Weeks | HCV RNA Change From Baseline | Change at Week 4 | -3.98 log10 IU/mL | Standard Deviation 1.694 |
| LDV/SOF 12 Weeks | HCV RNA Change From Baseline | Change at Week 8 | -4.47 log10 IU/mL | Standard Deviation 0.662 |
| LDV/SOF 12 Weeks | HCV RNA Change From Baseline | Change at Week 12 | -4.61 log10 IU/mL | Standard Deviation 0.737 |
| LDV/SOF 24 Weeks | HCV RNA Change From Baseline | Change at Week 4 | -5.05 log10 IU/mL | — |
| LDV/SOF 24 Weeks | HCV RNA Change From Baseline | Change at Week 20 | -5.05 log10 IU/mL | — |
| LDV/SOF 24 Weeks | HCV RNA Change From Baseline | Change at Week 8 | -5.05 log10 IU/mL | — |
| LDV/SOF 24 Weeks | HCV RNA Change From Baseline | Change at Week 24 | -5.05 log10 IU/mL | — |
| LDV/SOF 24 Weeks | HCV RNA Change From Baseline | Change at Week 12 | -5.05 log10 IU/mL | — |
| LDV/SOF 24 Weeks | HCV RNA Change From Baseline | Change at Week 1 | -3.86 log10 IU/mL | — |
| LDV/SOF 24 Weeks | HCV RNA Change From Baseline | Change at Week 2 | -4.63 log10 IU/mL | — |
| LDV/SOF 24 Weeks | HCV RNA Change From Baseline | Change at Week 16 | -5.05 log10 IU/mL | — |
Secondary
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Weeks 1, 2, 4, 8,12, 16, 20, and 24
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LDV/SOF 12 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 12 | 100.0 percentage of participants |
| LDV/SOF 12 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 1 | 33.3 percentage of participants |
| LDV/SOF 12 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 2 | 66.7 percentage of participants |
| LDV/SOF 12 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 4 | 88.9 percentage of participants |
| LDV/SOF 12 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 8 | 88.9 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 2 | 0 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 20 | 100.0 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 4 | 100.0 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 24 | 100.0 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 12 | 100.0 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 8 | 100.0 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 1 | 0 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants With HCV RNA < LLOQ on Treatment | Week 16 | 100.0 percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< the LLOQ 4 weeks following the last dose of study drug.
Time frame: Posttreatment Week 4
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF 12 Weeks | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) | 88.9 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure
Virologic failure was defined as * On-treatment virologic failure * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment, * \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse) * Relapse * HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
Time frame: Up to Posttreatment Week 12
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF 12 Weeks | Percentage of Participants With Virologic Failure | 11.1 percentage of participants |
| LDV/SOF 24 Weeks | Percentage of Participants With Virologic Failure | 0 percentage of participants |