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nul-responder now on triple therapy
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nul-responder now on triple therapy

Hello,
I am a nul-responder to the standard treatment + 100mg of sofusbuvir. I was in a clinical trial and i got pulled early. I am now in another clinical trial of the standard care + 400mg of sofusbuvir. I am having trouble getting reliable data on nul-responders response to this 400mg sofusbuvir dose. Does anyone have knowledge on my odds. I get 50% - 80% when I search it, but there have been so few patients like me that I feel uninformed still.
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1815939_tn?1377995399
Sorry to hear treatment did not work for you the first time.

I am just wondering .... can you give us a few more details to your situation.

Genotype?

Liver Biopsy result?

Previous treatment?

How long were you in the first trial?  And just verifying that it was with SOC and Sofosbuvir 100 mg?

When did you go UND in this second trial with SOC and Sofosbuvir 400 mg.? And how long is the trial?
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Genotype?
Hello,
Liver Biopsy result? My liver is in great shape. This is not an issue.

Previous treatment? The one time I did treatment i was in a clinical trial for the same drug i'm on now, Sofosbuvir. It was phase II, and i was randomized to the 100mg group (educated guess by the clinic). I was on Sofosbuvir, Interferon (Pegasus), and Ribavirin. I have genotype 1.

How long were you in the first trial?  And just verifying that it was with SOC and Sofosbuvir 100 mg?  I was in the first trial for maybe 6 weeks. I was the first patient to go zero virus but then on the next blood draw I was back to my starting levels. This makes me odd. According to my Doctor, the reason I can't find stats on cases like mine is because there are none. So yes, SOC and Sofosbuvir, probably 100mg.

When did you go UND in this second trial with SOC and Sofosbuvir 400 mg.? And how long is the trial? I am getting my third weekly injection tomorrow. I will most likely get my blood counts then. They take blood weekly. This trial is for 90 days.

From what I gather, 90 days of SOC + Sofosbuvir 400mg has had a 100% cure rate. But, few people have been tested. 25 people? Not sure if that number is just SF. I'm worried it will not work and that I am building up resistances. It does not appear to build resistance from what I read. The next trial is without interferon, just Sofosbuvir and ribavirin. It looks to me like the two drug therapy is just as effective as the three.
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1815939_tn?1377995399
Thanks for the additional details.

If I recall correctly, I actually have not read about any cases such as yours, but that does not mean there have not been any. I treated with Inf., Riba, and Telaprevir and attained SVR in Feb. of this year so I have not researched all of the trials and studies going on. I do read about new developments and new drugs in the pipeline, but I just don't recall reading about a study with people taking Inf., Riba, and 100 mg of Sofosbuvir.

You may have read this but, if not, here is a summary of the Neutrino Study (Inf., Riba, and 400 mg Sofosbuvir). SVR was not 100% but it was very good.

NEUTRINO: Sofosbuvir Plus Peginterferon/Ribavirin Achieves High SVR12 Rate, Well Tolerated in Treatment-Naive Patients With Genotype 1, 4, 5, or 6 HCV

Date posted: 4/28/2013

    NEUTRINO: nonrandomized, open-label, single-arm phase III trial[1,2]

Summary of Key Conclusions

    Sofosbuvir plus peginterferon/ribavirin for 12 weeks achieved very high sustained virologic response rate at 12 weeks posttreatment (SVR12) in treatment-naive patients chronically infected with genotype 1, 4, 5, or 6 HCV
        90% SVR12 in overall patient population vs 60% for prespecified historical control (P < .001)
        ≥ 80% SVR12 in all patient subgroups, including black patients, patients with cirrhosis, and patients with IL28B non-CC genotype
        97% SVR12 rate in patients with genotype 4, 5, or 6 HCV
    Relapse was reason for all cases of virologic failure; no virologic breakthrough and no viral resistance detected
    Regimen generally well tolerated

Background

    Sofosbuvir (formerly GS-7977), potent uridine nucleotide analogue that inhibits HCV NS5B polymerase
    Sofosbuvir plus peginterferon/ribavirin for 12-24 weeks previously demonstrated favorable results in phase II ATOMIC trial in treatment-naive patients with genotype 1, 4, and 6 HCV (Capsule Summary)[3,4]
        SVR24: 87% to 89% in genotype 1, 82% in genotype 4, and 100% in genotype 6 HCV
        No virologic breakthrough in any treatment arms or genotype groups
        Low rate of virologic relapse
    Current study evaluated efficacy and safety of sofosbuvir plus peginterferon/ribavirin for 12 weeks in large group of treatment-naive patients chronically infected with genotype 1, 4, 5, or 6 HCV[1,2]

Summary of Study Design

    Inclusion criteria
        Chronic infection with genotype 1, 4, 5, or 6 HCV
        No previous HCV treatment
        Cirrhosis allowed
        No upper limits on age or body mass index (BMI)
        Opioid substitution allowed
        Adequate hematologic function
            Platelet count ≥ 90,000 cells/mm3
            Neutrophil count ≥ 1500 cells/mm3 (≥ 1000 cells/mm3 in black patients)
    All patients received 12 weeks of triple therapy
        Sofosbuvir 400 mg/day
        Peginterferon alfa-2a 180 µg/week
        Weight-based ribavirin 1000-1200 mg/day

Main Findings

    98% of patients completed all study therapy; only 7 patents (2%) discontinued therapy
        Reasons for discontinuation: adverse events (AEs) (n = 5), protocol violation (n = 1), consent withdrawal (n = 1)
    90% overall SVR 12 rate with sofosbuvir and peginterferon/ribavirin, meeting primary endpoint of superiority to 60% historical control rate (P < .001)
        HCV RNA < LLOQ
            Week 2: 91%
            Week 4: 99%
            Week 12 (end of treatment): 99%
            SVR12: 90%
    High SVR12 rates across all genotypes, with lowest rate (89%) among patients with genotype 1 HCV

All patient subgroups attained SVR12 rates ≥ 80% with sofosbuvir plus peginterferon/ribavirin, including HCV genotype/subtype (1, 1a, 1b, or 4, 5, 6) cirrhosis (presence or absence), race (black or nonblack), baseline HCV RNA level ( 1000 IU/mL

    No S282T mutations identified by population sequencing or deep sequencing
    Other NS5B genetic variants not associated with any change in phenotypic susceptibility to sofosbuvir or ribavirin


It is possible that someone in the tread about Sofosbuvir will know more about your situation. Here is a link to that thread. There are many posts in that thread but it appears that people are continually reading and posting in the thread. It may be beneficial for you to post in that thread and ask your question. Just go to the bottom of the posts in that thread and then post your question.

http://www.medhelp.org/posts/Hepatitis-C/Starting-Sofosbuvir-GS-5885/show/1875802

If I find anything more I will post it.
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