Harvoni after Relapse Trial

[AWorriedMom]

Ann Intern Med. 2014 Nov 4
Re-treatment of Chronic Hepatitis C Virus Genotype 1 Infection After Relapse: An Open-Label Pilot Study.
Osinusi A, Kohli A, Marti MM, Nelson A, Zhang X, Meissner EG, Silk R, Townsend K, Pang PS, Subramanian GM, McHutchison JG, Fauci AS, Masur H, Kottilil S.

Abstract

BACKGROUND:
The interferon (IFN)-free regimen of sofosbuvir and ribavirin for 24 weeks was recently approved to treat chronic hepatitis C virus (HCV) genotype 1 (GT-1) infection for patients ineligible for IFN. However, sofosbuvir plus ribavirin therapy is associated with relapse in 15% to 30% of patients with HCV GT-1. Neither the mechanism of relapse nor the optimal re-treatment strategy for these patients is defined.
OBJECTIVE:
To assess the safety and efficacy of sofosbuvir plus ledipasvir in patients with chronic HCV GT-1 that relapsed after sofosbuvir plus ribavirin therapy.
DESIGN:
Phase 2a, open-label study. (ClinicalTrials.gov: NCT01805882).
SETTING:
Single U.S site.
PATIENTS:
14 patients with HCV GT-1 that relapsed after treatment with sofosbuvir plus ribavirin for 24 weeks were re-treated with sofosbuvir plus ledipasvir for 12 weeks.
MEASUREMENTS:
HCV RNA concentration and population sequencing to detect NS5B S282T mutations.
RESULTS:
All 14 patients treated with sofosbuvir plus ledipasvir for 12 weeks achieved a sustained virologic response, including 7 with advanced liver disease (Knodell Histology Activity Index score of 3 or 4) and 1 with a detectable NS5B S282T mutation after sofosbuvir plus ribavirin therapy. Sofosbuvir plus ledipasvir was well-tolerated with few adverse events. Four grade 3 events (elevated serum creatinine in a patient with baseline renal insufficiency, hypercholesterolemia, and hypophosphatemia) occurred. There were no grade 4 events or treatment discontinuations.
LIMITATION:
Small sample size.
CONCLUSION:
The fixed-dose combination of sofosbuvir plus ledipasvir was efficacious in a small cohort of patients with HCV GT-1 that relapsed after sofosbuvir plus ribavirin therapy, even in the setting of advanced liver disease. Larger studies are needed to confirm these preliminary efficacy results.
PRIMARY FUNDING SOURCE:
National Institute of Allergy and Infectious Diseases, National Institutes of Health, National Cancer Institute, and Gilead Sciences.

[sunru]

Thanks for posting this. I haven't had a lot of time to keep up with study results. Very good to know. I was in a trial at NIH last summer and Dr. Kohli was my doctor. They have been doing continuous small studies to get an idea of the general picture of responses to various combinations with Gilead drugs. I am still doing follow-ups with NIH that will continue through June of 2015 and then once a year after that, they are very thorough with their studies and getting the information they need.

[milliehepc]

I hope I'll be one of the ones added to the success.  My insurance company refused to give me 12 weeks.  They said, I was now undetected, did not have ciriohsis....(geno type 1A - stage 2/3) and therefore did not require the 12 weeks.  

Now on to wait for the next six months and hope that the insurance company was right - against my doctor's recommendation.

Millie

[Dee1956]

Hi there! Thanks for sharing this.  This is really good news.  Even though a small study it still gives hope to people.
I appreciate you sharing!
Take Care, Dee