I relapsed on SOVALDI and Ribavirin

[billewingad]

I have Hep-C G2.
Started SOVALDI and Ribavirin 12 week treatment Dec 23, 2013 (viral load at 2.5 million),
within 4 weeks into treatment my Hep C virus was undetectable.
12 weeks end of treatment my Hep C virus was undetectable.
4 weeks after treatment my Hep C virus was undetected.
12 weeks after of treatment my Hep C virus was detected at 83,000 viral load. It relapsed.

What are my chances of a cure now?

[gibsongal]

where did you hear The Ledipasvir/Sofosbuvir is ONLY for genotype 1?

curious too…i did not hear that anyplace yet..

also i think my doc said it will be approved August…

perhaps october is when it will be available at the pharmacy..

[can-do-man]

"where did you hear The Ledipasvir/Sofosbuvir is ONLY for genotype 1?"
----------------------------------------
http://www.gilead.com/news/press-releases/2014/2/gilead-files-for-us-approval-of-ledipasvirsofosbuvir-fixeddose-combination-tablet-for-genotype-1-hepatitis-c

[billewingad]

Thanks can-do
but I would not jump to eliminating Ledipasvir/Sofosbuvir as a treatment for GT-2.
It is clear in the document and others that Ledipasvir/Sofosbuvir will be the first Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C, but doesn't state it is ONLY for GT-1. My wife and I talked to a Gilead representative about my relapse and the Rep told us about the new drug Ledipasvir/Sofosbuvir scheduled for FDA approval 10/10. The Rep did not say anything about it being exclusive to treating only GT-1

[can-do-man]

Anything is possible in the crazy world of treating Hep C, that said sense trials was only for genotype 1 it would be interesting to see whether Gilead or ones insurance would take that kind of risk.

Wishing you the best.

[HectorSF]

Gilead in their NDA has asked the FDA for approval for the Ledipasvir/Sofosbuvir tablet based on the ION-1, ION-2 and ION-3 studies which ONLY included for genotype 1 patients.
No trials using Ledipasvir/Sofosbuvir treatment were performed in other genotypes.

Gilead filed the NDA for LDV/SOF earlier this year (The Pharma Letter February 11) and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014.

From Gilead website...

"Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C

- See more at: http://www.gilead.com/news/press-releases/2014/2/gilead-files-for-us-approval-of-ledipasvirsofosbuvir-fixeddose-combination-tablet-for-genotype-1-hepatitis-c#sthash.vGTbvuU8.dpuf

"FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 10, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults.

The data submitted in the NDA support the use of LDV/SOF in patients with genotype 1 hepatitis C virus (HCV) infection, with a treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis. Approximately 75 percent of people infected with HCV in the United States have the genotype 1 strain of the virus. Approximately 75 percent of people infected with HCV in the United States have the genotype 1 strain of the virus.

“Today’s filing brings us one step closer to our goal of offering all patients with hepatitis C a simple, safe and highly effective all-oral treatment regimen,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “Based on the data from the Phase 3 ION studies, the LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as eight weeks and without the need for interferon injections or ribavirin.”

The FDA has assigned LDV/SOF a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomized to receive the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks. Trial participants included patients who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis."
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Gilead Announces SVR12 Rates From Three Phase 3 Studies Evaluating a Once-Daily Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients

Across the three studies, 1,952 patients with genotype 1 HCV infection were randomized to receive SOF/LDV with or without RBV for eight, 12 or 24 weeks of therapy. Of these, 1,512 patients were treatment-naïve, 440 were treatment experienced and 224 had compensated cirrhosis.

Study

Treatment Duration SVR12 Rates
ION-1 GT 1 treatment-naïve (including 15.7 percent (136/865) with cirrhosis)

SOF/LDV    12 weeks 97.7% (209/214)
SOF/LDV + RBV  12 weeks 97.2% (211/217)
SOF/LDV    24 weeks NA (n=217)
SOF/LDV + RBV  24 weeks NA (n=217)

ION-2 GT 1 treatment-experienced (including 20.0 percent (88/440) with cirrhosis)

SOF/LDV 12 weeks 93.6% (102/109)
SOF/LDV+RBV 12 weeks 96.4% (107/111)
SOF/LDV 24 weeks 99.1% (108/109)
SOF/LDV+RBV 24 weeks 99.1% (110/111)

ION-3 GT 1 treatment-naïve
SOF/LDV   8 weeks 94.0% (202/215)
SOF/LDV + RBV 8 weeks 93.1% (201/216)
SOF/LDV 12 weeks   95.4% (206/216)


Cheers!
Hector

[hoping4cure]

Perfect Results for Sovaldi/Ledipasvir, But Only With Ribavirin

Combination therapy with Gilead Sciences’ fixed-dose combination pill of Sovaldi (sofosbuvir) and the investigational ledipasvir, plus ribavirin, boasted perfect cure rates in treating people with hepatitis C virus (HCV) in a recent trial. This is particularly good news for those with genotype 3 of the virus, who enjoyed halved treatment times compared with current Sovaldi protocol. Results from the ongoing Phase II ELECTRON2 study of 12 weeks of therapy with twice-daily doses of the fixed combination of the polymerase inhibitor Sovaldi and the NS5A inhibitor ledipasvir (LDV/SOF), with and without ribavirin, were presented at the 49th annual meeting of the European Association for the Study of the Liver (EASL) in London.

For treatment-naive study participants with genotype 3, the triple-drug regimen led to a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure) in 100 percent (26/26) of the cases. For those with genotype 3 who did not take ribavirin, the cure rate was only 64 percent (16/25). Similarly, a group of participants with genotype 1 and decompensated or Child-Turcotte-Pugh Class B cirrhosis who also did not take ribavirin only had a cure rate of 65 percent (13/20). Finally, those with genotype 1 who had failed a previous attempt at therapy with Sovaldi and ribavirin were all cured (19/19) with triple therapy.

Thus, it would appear that, at least for the subgroups treated in this study who fared more poorly without the drug, ribavirin may remain a necessary adjunct to a 12-week course of Sovaldi/ledipasvir therapy.

“The ELECTRON2 data suggest that an all-oral regimen of LDV/SOF plus RBV has the potential to provide high cure rates for genotype 3 patients in just 12 weeks—half the duration of current all-oral treatment regimens,” Edward Gane, MD, deputy director and hepatologist at the New Zealand Liver Transplant Unit at the Auckland City Hospital in New Zealand, and principal investigator of the ELECTRON2 study, said in a release. “These results also suggest that LDV/SOF may be an effective treatment regimen for HCV genotype 1-infected patients who have failed a previous sofosbuvir-based regimen and those with advanced liver disease, including decompensated cirrhosis.”