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

PT-NANBH Clinical Trial

Official title:

Comparative Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir for 8 or 12 Weeks for Chronic Hepatitis C Genotype 6

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480166
• Other study ID #: 33196
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2015
• Last updated: August 21, 2017
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: August 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• PT-NANBH

Intervention

Drug:
• 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
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.

Locations

Country	Name	City	State
United States	Liver and Digestive Consultants	Houston	Texas
United States	Stanford University Medical Center	Palo Alto	California
United States	Digestive Health Associates	Plano	Texas
United States	San Jose Gastroenterology	San Jose	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (5)

Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93. doi: 10.1056/NEJMoa1316366. Epub 2014 Apr 11. — View Citation

Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Bräu N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11. — View Citation

Chao DT, Abe K, Nguyen MH. Systematic review: epidemiology of hepatitis C genotype 6 and its management. Aliment Pharmacol Ther. 2011 Aug;34(3):286-96. doi: 10.1111/j.1365-2036.2011.04714.x. Epub 2011 May 29. Review. — View Citation

Lam KD, Trinh HN, Do ST, Nguyen TT, Garcia RT, Nguyen T, Phan QQ, Nguyen HA, Nguyen KK, Nguyen LH, Nguyen MH. Randomized controlled trial of pegylated interferon-alfa 2a and ribavirin in treatment-naive chronic hepatitis C genotype 6. Hepatology. 2010 Nov;52(5):1573-80. doi: 10.1002/hep.23889. — View Citation

Lawitz E, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 Aug 15;369(7):678-9. doi: 10.1056/NEJMc1307641. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Day 1 of treatment to 12 weeks post treatment