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Author Topic: Harvoni after Relapse Sovaldi Ribavirin GT1 Trial NCT01805882  (Read 10151 times)

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Offline Lynn K

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Harvoni after Relapse Sovaldi Ribavirin GT1 Trial NCT01805882
« on: December 06, 2014, 11:31:57 pm »
http://www.ncbi.nlm.nih.gov/pubmed/25364884

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.


Also

http://www.familypracticenews.com/news/journals/single-article/sofosbuvirledipasvir-effective-for-relapsed-hep-c-patients/61f3e868769ed6ee913673ba6638dc3e.html

Journals
Sofosbuvir/ledipasvir effective for relapsed hep C patients

By: KAREN BLUM
November 3, 2014
Vitals

Key clinical point: Patients with chronic hepatitis C genotype 1 infection who relapse after sofosbuvir/ribavirin treatment may be successfully retreated with sofosbuvir/ledipasvir.

Major finding: All patients achieved sustained viral response to treatment.

Data source: A phase IIa, open-label study of 14 patients given sofosbuvir plus ledipasvir for 12 weeks after relapsing from 24 weeks of treatment with sofosbuvir plus ribavirin.

Disclosures: The study was supported by the National Institute of Allergy and Infectious Diseases, the National Institutes of Health, the National Cancer Institute, and Gilead Sciences (manufacturer of sofosbuvir/ledipasvir). Two authors are employed by Gilead; two others disclosed other company-sponsored findings during the study period.

Patients with chronic hepatitis C genotype 1 infection who relapse after sofosbuvir plus ribavirin may be successfully retreated with sofosbuvir plus ledipasvir, a new study demonstrated.

During the study, investigators approached patients treated with sofosbuvir plus ribavirin for 24 weeks in the National Institute of Allergy and Infectious Diseases (NIAID) SPARE study who relapsed after treatment. The participants, mostly black men with an interleukin-28B non-CC genotype, were offered retreatment with sofosbuvir plus ledipasvir for 12 weeks in the ongoing, phase IIa, open-label NIAID SYNERGY study. Fourteen enrolled. The medication was a single daily tablet of 400 mg of sofosbuvir and 90 mg of ledipasvir.
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All patients achieved sustained viral response to treatment (SVR12), including seven who had advanced liver disease and one with a detectable NS5B S282T mutation, according to work directed by Dr. Anu Osinusi of Gilead Sciences, manufacturer of the combination drug. Most adverse events, including loose stool, constipation, headache, myalgia, nasal congestion, and pruritic rash, were mild.

The research suggests that patients who have viral relapse after sofosbuvir/ribavirin “can be successfully retreated with sofosbuvir/ledipasvir for 12 weeks,” the authors wrote. “The low incidence of adverse events, low pill burden, short treatment duration, and high efficacy demonstrated in this group and other populations make this drug combination attractive in a real-world setting.”

The study was supported by NIAID, the National Institutes of Health, the National Cancer Institute, and Gilead Sciences (manufacturer of sofosbuvir/ledipasvir). Two authors are employed by Gilead; two others disclosed other company-sponsored findings during the study period.
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline Mike

  • Member
  • Posts: 999
Re: Harvoni after Relapse Sovaldi Ribavirin GT1 Trial NCT01805882
« Reply #1 on: December 07, 2014, 11:31:49 am »
That's some good news! Thanks for posting.

Mike
Genotype 1a
Treated 2001 with PEG and RIBV
Treated in 2014 SOL+PEG+RIBV
Cured July 2014

Offline Lynn K

  • Global Moderator
  • Member
  • Posts: 4,544
  • Get tested, get treated, get cured, fight Hep c!
Re: Harvoni after Relapse Sovaldi Ribavirin GT1 Trial NCT01805882
« Reply #2 on: December 07, 2014, 03:41:27 pm »
Good news for me and anyone else who failed Sovaldi based treatments. They didn't list Sovaldi Olysio but the issue was Sovaldi resistance so even though the study was small it does show Sovaldi resistance is not a factor at least for people who relapse after responding while on treatment.
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

 


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