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Knowing his original post here is somewhat dated – I can not help but wonder if Jonathan successfully pursued retreatment. Hopefully he will comment when he comes back online.
My situation is somewhat similar – Viekira/RBV failure (as previously posted). And my gastroenterologist is also directing me towards the AASLD recommendation for retreatment with simeprevir/sofosbuvir and RBV.
It seems there may not be an experience based consensus for DAA retreatment – maybe because it is all too new. In lieu of a better recommendation – I am inclined to follow my GI’s advice.
I do see that Mesochem lists simeprevir on their website – not sure what that means in terms of real-world availability.
Will explore this and other possible retreatment options during my upcoming GP2U appointment.
J
GT 1a (~196
Diagnosed Non A/B ’85 – HCV ‘89
Rebetron INF/RBV 17 months 2000 – Failure
Infergen INF/RBV 11 months 2002 – Failure
Viekira Pak + RBV 12 weeks 2015 – Failure
VL Und at +3 weeks > EOT – EOT+12 weeks 2,240k
Resistance Tests – NS5a Q30R
SMV/DCV/SOF + RBV 24 weeks 2016
VL Det <15 +2 and +4 weeks – Und +8 weeks > EOT
SVR4, SVR12 and SVR24 UndetectedJonathan
I did not have HCV drug resistance testing performed prior to my therapy (Viekira/RBV) – hence no baseline data for RAVs.
Subsequent HCV drug resistance testing by LabCorp (Monogram Biosciences) shows an NS5A Q30R RAV and resistance to both ledipasvir and ombitasvir. Without prior testing – I have no way to be sure that this RAV is treatment emergent.
While taking Viekira/RBV – I did experience early viral suppression. Started with a modest 500k VL that went to undetected within 12 days and remained undetected through the 12 week course of therapy. AST/ALT also dropped from ~ 60/100 to a remarkable 13/11 within the first 12 days of therapy – the lowest numbers I had seen in over 40 years.
Side effects during treatment were negligible – if even present. Actually felt much better during treatment than before – or certainly after.
The success was short lived. Testing at EOT plus 12 weeks showed a 2,240k VL and LFTs headed back to pretreatment levels.
Covered most of this in my first post on this forum a week ago – sorry to be repetitive here.
By simply following the AASLD recommendations for retreatment – or those outlined in the article Dr. Freeman recently posted (authored by Dr. Jordan Feld just last month) – I would be back to watchful waiting in the hope that new medicines and treatment protocols would soon appear.
Having waited for decades – and coming so close while experiencing a wonderful but brief respite – I suppose my desire to try another therapy is understandable – even if misguided. My GI is willing to support my decision to go forward with the simeprevir/sofosbuvir + RBV …. I have to admit to second thoughts though. Have read a number of articles covering the increase of RAVs with unsuccessful retreatment protocols.
You mentioned undergoing additional resistance testing – curious as to your strategy. I was thinking about another NS5A resistance assy that includes daclatasvir (Quest Diagnostics) – not sure if it would be helpful – will discuss it with the treating physician should I go forward.
Stalled here at the moment.
All the best
J.
GT 1a (~196
Diagnosed Non A/B ’85 – HCV ‘89
Rebetron INF/RBV 17 months 2000 – Failure
Infergen INF/RBV 11 months 2002 – Failure
Viekira Pak + RBV 12 weeks 2015 – Failure
VL Und at +3 weeks > EOT – EOT+12 weeks 2,240k
Resistance Tests – NS5a Q30R
SMV/DCV/SOF + RBV 24 weeks 2016
VL Det <15 +2 and +4 weeks – Und +8 weeks > EOT
SVR4, SVR12 and SVR24 UndetectedJonathan
Have read your posts here and am very sorry that you too failed to achieve SVR – our cases are indeed similar.
Interesting that you had NS5A resistance testing done before your GZP/EBR therapy – suppose it was part of the Merck trial.
And yes – I had NS3/4A resistance tested. Luckily – against the four readily available protease inhibitors – there were no RAVs detected (note that treatment significant baseline NS3 RAVs are rare). Dodged the prevalent Q80K (present in > 40% of GT 1a patients here) – so it looks like the effectiveness of simeprevir will not be impaired. Have read that there is no clear impact of Q80K on extended simeprevir/sofosbuvir therapy anyway.
I too have also read about the durability of treatment emergent NS5A RAVs. Unlike the NS3 mutations (such as Q80K that fade in ~ 72 weeks) – treatment emergent NS5A RAVs (like Q30R) soldier on well past 96 weeks (the extent of most tests to date). This is another reason that the next course of treatment after DAA failure needs to be carefully chosen.
You have probably studied most of the retreatment options by now. I see that Dr. Freeman just posted a link to another current AASLD hosted article on the subject. The bottom line seems the same on most I have read.
Curious as to your thought on adding daclatasvir to your gastroenterologist’s AASLD based treatment recommendation. It looks like a recent recommendation I have seen for “desperation time” where both serious NS3 and NS5A RAV’s are present (R155, A156, D16
. Would be extremely cautious about throwing everything in the mix – though I can understand the desire to do so.The more I read on retreatment – the more inclined I am to wait awhile longer – maybe just a year. There are a number of potent NS5A inhibitors on the horizon that look very promising. And those existing emergent RAV’s should be easier to deal with by then just with time alone. Will see – waiting isn’t my strong suit.
I wish you the best Jonathan – please keep us posted on your progress. Greatly looking forward to your success story.
And I need to add this for others who are seeking treatment ..
The success rate in achieving SVR with existing DAA therapies of the type available here-and-now is remarkably high – have witnessed it first-hand. Only a very few of us are unfortunate enough to miss on the first attempt – and with the advances in HCV DAA therapies coming so quickly now – there will soon be a day where we are all free of this.
Have been reluctant to post about my lack of success this go-round – concerned that others might become overly worried when they really shouldn’t be. Most everyone will beat this now first try – and I will catch up with them soon.
Probably before I wear-out the new set of tires on my motorcycle – California coast and sunny days ahead.
J.
GT 1a (~196
Diagnosed Non A/B ’85 – HCV ‘89
Rebetron INF/RBV 17 months 2000 – Failure
Infergen INF/RBV 11 months 2002 – Failure
Viekira Pak + RBV 12 weeks 2015 – Failure
VL Und at +3 weeks > EOT – EOT+12 weeks 2,240k
Resistance Tests – NS5a Q30R
SMV/DCV/SOF + RBV 24 weeks 2016
VL Det <15 +2 and +4 weeks – Und +8 weeks > EOT
SVR4, SVR12 and SVR24 UndetectedJonathan
Curious about your progress – please check your PM
J.
GT 1a (~196
Diagnosed Non A/B ’85 – HCV ‘89
Rebetron INF/RBV 17 months 2000 – Failure
Infergen INF/RBV 11 months 2002 – Failure
Viekira Pak + RBV 12 weeks 2015 – Failure
VL Und at +3 weeks > EOT – EOT+12 weeks 2,240k
Resistance Tests – NS5a Q30R
SMV/DCV/SOF + RBV 24 weeks 2016
VL Det <15 +2 and +4 weeks – Und +8 weeks > EOT
SVR4, SVR12 and SVR24 Undetected
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