PT-NANBH
Conditions
Keywords
hepatitis C, genotype 6
Brief summary
The primary objectives of this study are to describe the efficacy of: 1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6 2. 12-week treatment of SOF/LED for all other HCV-6 populations
Detailed description
The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.
Interventions
DRUG8 weeks SOF/LED
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
DRUG12 weeks SOF/LED
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
Sponsors
Gilead Sciences
Stanford University
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
1. Male or female, age ≥18 years 2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6 3. Selected to start on treatment by their treating providers 4. Willing and able to provide informed consent 5. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments 6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline 7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 8. Lactating females must agree to discontinue nursing before the study drug is administered
Exclusion criteria
1. Previous recipient of a liver transplant 2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment | 12 weeks after end of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment. | Day 1 of treatment to 12 weeks post treatment | Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 8 Weeks SOF/LED Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
8 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food. | 20 |
| 12 Weeks SOF/LED Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
12 weeks SOF/LED: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food. | 36 |
| Extended Treatment to 12 Weeks SOF/LED Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator's preference | 4 |
| Total | 60 |
Baseline characteristics
| Characteristic | 12 Weeks SOF/LED | Extended Treatment to 12 Weeks SOF/LED | 8 Weeks SOF/LED | Total |
|---|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 12 | 54 years STANDARD_DEVIATION 10 | 57 years STANDARD_DEVIATION 8 | 59 years STANDARD_DEVIATION 10 |
| Alanine Aminotransferase (ALT) | 68 U/L | 33 U/L | 44 U/L | 59 U/L |
| Albumin | 4.0 g/dL STANDARD_DEVIATION 0.7 | 3.5 g/dL STANDARD_DEVIATION 1.5 | 4.3 g/dL STANDARD_DEVIATION 0.4 | 4.0 g/dL STANDARD_DEVIATION 0.7 |
| Aspartate Aminotransferase (AST) | 48 U/L | 28 U/L | 36 U/L | 39 U/L |
| Baseline Cirrhosis | 27 Participants | 0 Participants | 0 Participants | 27 Participants |
| BMI | 24.2 kg/m^2 STANDARD_DEVIATION 2.7 | 24.1 kg/m^2 STANDARD_DEVIATION 3.6 | 22.4 kg/m^2 STANDARD_DEVIATION 4.2 | 23.6 kg/m^2 STANDARD_DEVIATION 3.3 |
| Comorbidities Chronic Obstructive Pulmonary Disease (COPD) | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Comorbidities Coronary Artery Disease (CAD) | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Comorbidities Diabetes | 6 Participants | 0 Participants | 1 Participants | 7 Participants |
| Comorbidities Hyperlipidemia | 6 Participants | 0 Participants | 3 Participants | 9 Participants |
| Comorbidities Hypertension | 10 Participants | 0 Participants | 5 Participants | 15 Participants |
| Creatinine | 0.9 mg/dL STANDARD_DEVIATION 0.2 | 0.9 mg/dL STANDARD_DEVIATION 0.1 | 0.8 mg/dL STANDARD_DEVIATION 0.1 | 0.8 mg/dL STANDARD_DEVIATION 0.2 |
| Decompensated Cirrhosis | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| HCV Genotype SubType a/b | 9 Participants | 2 Participants | 2 Participants | 13 Participants |
| HCV Genotype SubType c | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| HCV Genotype SubType c-l | 15 Participants | 2 Participants | 8 Participants | 25 Participants |
| HCV Genotype SubType m | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Hemoglobin | 14.2 g/dL STANDARD_DEVIATION 1.6 | 14.8 g/dL STANDARD_DEVIATION 1.1 | 14.3 g/dL STANDARD_DEVIATION 1.3 | 14.2 g/dL STANDARD_DEVIATION 1.5 |
| Hepatocellular Carcinoma | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| International Normalized Ratio (INR) | 1.0 ratio STANDARD_DEVIATION 0.1 | 1.0 ratio STANDARD_DEVIATION 0 | 1.0 ratio STANDARD_DEVIATION 0.2 | 1.0 ratio STANDARD_DEVIATION 0.1 |
| log10 HCV RNA | 6.5 log10 (IU/ml) STANDARD_DEVIATION 0.6 | 7.2 log10 (IU/ml) STANDARD_DEVIATION 0.3 | 6.2 log10 (IU/ml) STANDARD_DEVIATION 0.8 | 6.5 log10 (IU/ml) STANDARD_DEVIATION 0.7 |
| MELD, cirrhotics only | 6.9 units on a scale STANDARD_DEVIATION 1.6 | 0 units on a scale STANDARD_DEVIATION 0 | 0 units on a scale STANDARD_DEVIATION 0 | 6.9 units on a scale STANDARD_DEVIATION 1.6 |
| Platelets | 181 K/uL | 201 K/uL | 213 K/uL | 201 K/uL |
| Prior Treatment | 15 Participants | 0 Participants | 0 Participants | 15 Participants |
| Proton Pump Inhibitor (PPI) usage | 9 Participants | 0 Participants | 3 Participants | 12 Participants |
| Race/Ethnicity, Customized Cambodian | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Other Asian | 3 Participants | 0 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Vietnamese | 30 Participants | 4 Participants | 16 Participants | 50 Participants |
| Region of Enrollment United States | 36 Participants | 4 Participants | 20 Participants | 60 Participants |
| Sex: Female, Male Female | 15 Participants | 1 Participants | 9 Participants | 25 Participants |
| Sex: Female, Male Male | 21 Participants | 3 Participants | 11 Participants | 35 Participants |
| Total bilirubin | 0.8 mg/dL STANDARD_DEVIATION 0.4 | 0.9 mg/dL STANDARD_DEVIATION 0.1 | 0.7 mg/dL STANDARD_DEVIATION 0.1 | 0.7 mg/dL STANDARD_DEVIATION 0.3 |
| White Blood Cell Count (WBC) | 6.0 K/uL STANDARD_DEVIATION 2.1 | 5.3 K/uL STANDARD_DEVIATION 0.5 | 5.5 K/uL STANDARD_DEVIATION 1.4 | 5.8 K/uL STANDARD_DEVIATION 1.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 36 | 0 / 4 |
| other Total, other adverse events | 2 / 20 | 5 / 36 | 0 / 4 |
| serious Total, serious adverse events | 0 / 20 | 2 / 36 | 0 / 4 |
Outcome results
Primary
Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment
Time frame: 12 weeks after end of therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 8 Weeks SOF/LED | Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment | 19 Participants |
| 12 Weeks SOF/LED | Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment | 34 Participants |
| Treatment Extension to 12 Weeks SOF/LED | Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment | 4 Participants |
Secondary
Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.
Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Time frame: Day 1 of treatment to 12 weeks post treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 8 Weeks SOF/LED | Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment. | 0 Participants |
| 12 Weeks SOF/LED | Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment. | 0 Participants |
| Treatment Extension to 12 Weeks SOF/LED | Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment. | 0 Participants |