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Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6

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ClinicalTrials.gov Identifier: NCT02480166
Recruitment Status : Completed
First Posted : June 24, 2015
Results First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Mindie H. Nguyen, Stanford University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: PT-NANBH
Interventions: Drug: 8 weeks SOF/LED
Drug: 12 weeks SOF/LED

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

Extended Treatment to 12 Weeks SOF/LED Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator’s preference

Participant Flow:   Overall Study
    8 Weeks SOF/LED   12 Weeks SOF/LED   Extended Treatment to 12 Weeks SOF/LED
STARTED   20   36   4 
COMPLETED   20   36   4 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

Extended Treatment to 12 Weeks SOF/LED Subjects without cirrhosis or prior treatment history received extended treatment to 12 weeks by investigator’s preference
Total Total of all reporting groups

Baseline Measures
   8 Weeks SOF/LED   12 Weeks SOF/LED   Extended Treatment to 12 Weeks SOF/LED   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   36   4   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 57  (8)   60  (12)   54  (10)   59  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      9  45.0%      15  41.7%      1  25.0%      25  41.7% 
Male      11  55.0%      21  58.3%      3  75.0%      35  58.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Vietnamese      16  80.0%      30  83.3%      4 100.0%      50  83.3% 
Cambodian      1   5.0%      3   8.3%      0   0.0%      4   6.7% 
Other Asian      3  15.0%      3   8.3%      0   0.0%      6  10.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   20   36   4   60 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 22.4  (4.2)   24.2  (2.7)   24.1  (3.6)   23.6  (3.3) 
Comorbidities 
[Units: Participants]
Count of Participants
       
Diabetes   1   6   0   7 
Hypertension   5   10   0   15 
Hyperlipidemia   3   6   0   9 
Coronary Artery Disease (CAD)   0   1   0   1 
Chronic Obstructive Pulmonary Disease (COPD)   0   1   0   1 
HCV Genotype SubType 
[Units: Participants]
Count of Participants
       
a/b   2   9   2   13 
c-l   8   15   2   25 
 1   0   0   1 
 0   2   0   2 
Baseline Cirrhosis 
[Units: Participants]
Count of Participants
 0   27   0   27 
Decompensated Cirrhosis [1] 
[Units: Participants]
Count of Participants
 0   2   0   2 
[1] Decompensated cirrhosis is defined as presence/history of variceal bleeding, hepatic encephalopathy, or ascites at baseline.
Hepatocellular Carcinoma 
[Units: Participants]
Count of Participants
 0   3   0   3 
Prior Treatment 
[Units: Participants]
Count of Participants
 0   15   0   15 
Proton Pump Inhibitor (PPI) usage 
[Units: Participants]
Count of Participants
 3   9   0   12 
MELD, cirrhotics only [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 0  (0)   6.9  (1.6)   0  (0)   6.9  (1.6) 
[1] The Model for End-Stage Liver Disease (MELD) Score uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. It is calculated according to the following formula: MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43. The total possible range for MELD scores is 6 (less ill) to 40 (gravely ill).
log10 HCV RNA 
[Units: Log10 (IU/ml)]
Mean (Standard Deviation)
 6.2  (0.8)   6.5  (0.6)   7.2  (0.3)   6.5  (0.7) 
White Blood Cell Count (WBC) 
[Units: K/uL]
Mean (Standard Deviation)
 5.5  (1.4)   6.0  (2.1)   5.3  (0.5)   5.8  (1.8) 
Hemoglobin 
[Units: g/dL]
Mean (Standard Deviation)
 14.3  (1.3)   14.2  (1.6)   14.8  (1.1)   14.2  (1.5) 
Platelets 
[Units: K/uL]
Median (Inter-Quartile Range)
 213 
 (186 to 240) 
 181 
 (133 to 223) 
 201 
 (189 to 225) 
 201 
 (151 to 223) 
Creatinine 
[Units: mg/dL]
Mean (Standard Deviation)
 0.8  (0.1)   0.9  (0.2)   0.9  (0.1)   0.8  (0.2) 
International Normalized Ratio (INR) [1] 
[Units: Ratio]
Mean (Standard Deviation)
 1.0  (0.2)   1.0  (0.1)   1.0  (0.0)   1.0  (0.1) 
[1] The INR is based on the ratio of the patient's prothrombin time and the normal mean prothrombin time. The normal range for a healthy person who is not on anticoagulant therapy is 0.8-1.2, while higher values are targeted for people on anticoagulant therapy.
Total bilirubin 
[Units: mg/dL]
Mean (Standard Deviation)
 0.7  (0.1)   0.8  (0.4)   0.9  (0.1)   0.7  (0.3) 
Aspartate Aminotransferase (AST) [1] 
[Units: U/L]
Median (Inter-Quartile Range)
 36 
 (27 to 44) 
 48 
 (33 to 95) 
 28 
 (21 to 34) 
 39 
 (29 to 69) 
[1] AST is an enzyme that is secreted from the liver and can be found in liver, heart, muscle tissue, pancreas and kidneys. Elevated levels of AST may indicate inflammation or liver damage. Normal range for AST is typically 10-40 U/L.
Alanine Aminotransferase (ALT) [1] 
[Units: U/L]
Median (Inter-Quartile Range)
 44 
 (31 to 59) 
 68 
 (46 to 105) 
 33 
 (21 to 41) 
 59 
 (36 to 76) 
[1] ALT is an enzyme that is secreted by the liver into the blood. Main storage of this enzyme is in the liver and elevated levels of ALT in the blood may indicate liver inflammation or damage. Normal range for ALT is typically between 7-56 U/L.
Albumin 
[Units: g/dL]
Mean (Standard Deviation)
 4.3  (0.4)   4.0  (0.7)   3.5  (1.5)   4.0  (0.7) 


  Outcome Measures

1.  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 ]

2.  Secondary:   Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.   [ Time Frame: Day 1 of treatment to 12 weeks post treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our population was small and our study was not powered to be able to determine significant differences between groups.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mindie H. Nguyen, MD, MAS
Organization: Stanford University Medical Center
phone: 650-4985691
e-mail: mindiehn@stanford.edu


Publications:


Responsible Party: Mindie H. Nguyen, Stanford University
ClinicalTrials.gov Identifier: NCT02480166     History of Changes
Other Study ID Numbers: 33196
First Submitted: June 17, 2015
First Posted: June 24, 2015
Results First Submitted: July 17, 2017
Results First Posted: September 19, 2017
Last Update Posted: September 19, 2017