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Avatar universal

I relapsed on SOVALDI and Ribavirin

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?
77 Responses
Avatar universal
Very sorry to hear this. I can only imagine what a let down this is for you (and for the rest of us, too).

Hang in there. A better treatment with higher cure rates for all genotypes is only five months away (Sofosbuvir/Ledipasvir combo pill).  


Nan
Avatar universal
So sorry to hear that.  I just finished SOV/RBV 12 weeks GT2 tx naive F3/4 BMI 36. I think my real odds of SVR are more likely in the 80-90 range. Hope having a pre treatment VL just over 800,000 might be a little more helpful than in the millions.

Could you please tell us if you were tx naive or nonresponder?   cirrhotic F3/4 or non-cirrhotic F0-F3.  BMI over 32-35 range  other existing conditions etc.
Did you have to reduce the Ribavirin dose during treatment because of anemia or other reasons? if you missed taking any of your pills was it more than just a couple times.  Variations of up to 4 hours shouldn't make a difference

This information may be helpful for some to get a better understanding of what situations may contribute to a lower percentage rate of SVR.

FYI general information about trials and GT2
Clinical trails so far have been very limited for those with F4 and other conditions like high BMI etc.  After FDA approval the SVR  rates can be lower and even more lower for those with multiple other contributing factors than the trial results.  Maybe even up to 10 -15+  percentage lower.

The VA Sovaldi Criteria for Use March 2014 includes this statement.
"In genotype 2 treatment-experienced patients, the use of sofosbuvir and ribavirin for 16 weeks may be considered as an alternative treatment option in treatment-experienced patients based on data from one of two small studies.  Among treatment-experienced patients from the VALENCE study, SVR was achieved in 91% (30/33) of non-cirrhotics and 88% (7/8) of cirrhotics with sofosbuvir/ribavirin treatment for 12 weeks.  In the FUSION study, a statistically insignificant increase in SVR rates was seen with extending sofosbuvir/ribavirin therapy from 12 to 16 weeks in prior nonresponders without cirrhosis (70% [7/10] vs. 88% [7/8], respectively) and in treatment-experienced cirrhotics (60% [6/10] vs. 78% [7/9], respectively).  Another treatment option is sofosbuvir in combination with peginterferon and ribavirin for 12 weeks in treatment-experienced cirrhotic patients.  In Lonestar-2, 22/23 (96%) HCV Genotype 2 treatment experienced patients (55% had cirrhosis overall) achieved an SVR.  Neither of these regimens is FDA approved."

New study now recruiting veterans at some locations in US
A Phase 4, Multicenter, Open Label Study to Investigate the Efficacy and Safety of an All Oral Combination of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis VALOR-HCV: Veterans Affairs alL Oral Regimen of SOF+RBV in GT2 HCV
https://clinicaltrials.gov/ct2/show/study/NCT02128542

I have posted a lot of information of my pre treatments history, labs, biopsies or existing conditions in my first journal and my treatment labs and side effects in my other journal.  Click my name and look in the lower left side of the page for my journals if interested  (I probably provided much more detail than needed)

I really hope we don't get many failing the new treatments.  For anyone completing the new treatments after 12 weeks post EOT when you get your results hopefully SRV but even if no please include some basic pre treatment and treatment info with some basic test info and condition status.   This will help us to understand who might have a harder time achieving SVR and info to fight to get an extra 4 weeks or other possible variances in treatment if they become known.  It's interesting how once the drug companies get approval they may be less likely to provide more negative information if any until they have to.
446474 tn?1446351282
I am sorry to hear that you failed the treatment. Unfortunately some of us will fail the current treatments. The current treatment are not 100% yet. For those of us who failed are options are limited currently because we failed the latest and greatest but in time (as other also fail and newer treatments are being tested in trials or available on the market) there will be other options available in the future geared to those who fail these early Sovaldi treatments.

I hope your liver disease is not too advanced so that you have time to wait for better treatments to be available. Unfortunately there are no treatments for genotype 2 that I am aware of in the near future. Maybe something off label? The Ledipasvir/Sofosbuvir Fixed-Dose Combination, one pill a day which is expected to be approved by the FDA in October is ONLY for genotype 1 infection as are most of the other near future treatments. (ABBVIE, Bristol-Myers Squibb DCV+ASV ) As are the other major treatments that have been submitted to the FDA for approval. Perhaps off label Daclatasvir plus sofosbuvir/Sovaldi when daclatasvir becomes available? Or longer duration of Sovaldi + ribavirin? It mostly depends upon what factors make your hepatitis hard to treat. Cirrhosis,

"RESULTS: Overall, 211 patients received treatment. Among patients with genotype 1 infection, 98% of 126 previously untreated patients and 98% of 41 patients who did not have a sustained virologic response with HCV protease inhibitors had a sustained virologic response at week 12 after the end of therapy. A total of 92% of 26 patients with genotype 2 infection and 89% of 18 patients with genotype 3 infection had a sustained virologic response at week 12."

I failed 48 weeks of Sovaldi + ribavirin in an early Gilead trial and now the virus has recurred and is attacking my new donor liver. That was my second hep C treatment failure. But I am planning to keep trying treatments until I am cured whether sooner or later.
Hang in there. One treatment failure isn't the final outcome!

Hector
Avatar universal
Thanks Nan
Avatar universal
My age 51
255 lb
no cirrhoses
no inflammation
no symptoms

I do have a fatty liver (hereditary)
Avatar universal
where did you hear The Ledipasvir/Sofosbuvir is ONLY for genotype 1?
Avatar universal
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..
Avatar universal
"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
Avatar universal
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
Avatar universal
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.
446474 tn?1446351282
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."
----------------------------------------------------------------------------------------------------
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
Avatar universal
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.”
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