Forum Replies Created
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Outstanding news !!
Was waiting to hear you finally beat this.
It’s about time buddy
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 UndetectedHeartbreaking
Will not forget all the help he provided
Had no idea he was so ill – he never let on in the conversations we had. Can remember rejoicing in the news of his attaining SVR
At a loss for words
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 UndetectedThis is outstanding news Gaj ….
Could echo Lilyfield’s thoughtful response – will not forget all the help you provided me along the way.
Just wonderful to hear that you made it this time around. Wow ….
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 UndetectedSome progress – and a name for Gilead’s new 3DAA
Vosevi
Gilead Press Release – June 23, 2017
European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes
Not certain how long the European Commission will take to approve the drug.
The FDA here has a target action date under the Prescription Drug User Fee Act of August 8, 2017.
It will be very interesting to see how Gilead prices Vosevi and how it is marketed alongside their existing Epclusa (Sofosbuvir/Velpatasvir) and Harvoni (Sofosbuvir/Ledipasvir)
Will be watching – and watching too for the generic counterparts
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 UndetectedIn Allman’s own words – here from an article in Everyday Health – December 2011
__________Allman was diagnosed with chronic hepatitis C after years of complaining of low energy and fatigue. “I didn’t know that much about the disease at the time, which made it all the more daunting. I just knew that it would be a long haul,” Allman says of his diagnosis. “I also was unsure about what it would mean for my life and for my ability to play my music, but I didn’t want it to slow me down.”
Allman, however, didn’t immediately seek treatment. He waited until he faced the music and shared the news with his friends and family. “I wasn’t sure what my friends and family would think when I told them I had it, but they were extremely supportive. I honestly believe people can get through this thing with the support of their friends, family and their doctor,” he says. “Looking back, I wish I had taken steps against my disease sooner.”
Allman’s hepatitis C was treated with interferon, a medication made with proteins similar to those your body makes to fight off infections. “I have to tell you, treatment was tough, but I never looked back because I was determined to beat the virus,” he recalls.
However, because his infection was treated so late, the therapy failed. His doctor then advised Allman that he would need a liver transplant. “It was scary. I’m not going to lie about that,” he admits. “I was feeling pretty tired, real lethargic, and was just waiting. But when I got the call that there was a liver for me, oh man, I was ready for it.”
It’s been about a year and a half since Allman got a new liver, and, since then, he has returned to touring with the Allman Brothers Band and his solo band and has released his first album in 14 years, Low Country Blues. “What a difference a year can make,” he says.
While he’s enjoying having his life back on track, Allman wants to make sure those living with chronic hepatitis C hear his message loud and clear. “Looking back on what I went through, I want other people to know that doing nothing is not an option,” Allman says.
http://www.everydayhealth.com/hepatitis/1213/gregg-allman-living-with-chronic-hepatitis-c.aspx
__________“Doing nothing is not an option” …. words to live by.
RIP
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 UndetectedCurious to know of any updates on the general availability of voxilaprevir – or any of the other second generation NS3/4A protease inhibitors.
Gilead submitted their three-drug combo (voxilaprevir/velpatasvir/sofosbuvir) for FDA approval here last December – have not read of their progress.
Are the manufacturers of generic medicines moving closer to the release of NS3/4A protease inhibitors ??
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 UndetectedThanks Mike – followed you here actually …..
mgalbrai wrote:Hi, Did I see your post on HepMag? Anyhow, you have found the answer to your recent setback. Sick people who come here don’t leave that way.
Simple as that.
MikeReading your posts on the other forum about your success with generic DAA medicines brought me here. You my friend are a true trailblazer.
As you can see from my profile – your above statement is true.
Thank you for all that you have done to help others like myself find the resources here at FixHepC
J
PS: Would like to add my thanks to Greg Jefferys – I was reading his excellent work online before starting DAA therapy. Another inspirational fellow to be sure.
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 UndetectedThank you Dr. Freeman for all your help ….
”James-Freeman-facebook” wrote:For retreatment in GT1 DAA failures 3 drugs are better than 2. For 2 drugs Sof+Vel would be the current best choice.
Options for 3D treatment include:
Sof+Dac+Simeprevir (about $4500 for 12 weeks)
Sof+Dac+Asunaprevir (about $3000 for 12 weeks)Or for those who can access branded meds via insurance
Viekira pac + Sofosbuvir
Zepatier + SofosbuvirWith the sofosbuvir as a generic for under $1000 for 12 weeks
All can be +/- ribavirin for a 4th weaker agent.
Obtained the 24 week supply of DCV/SOF through the Redemption program. The SMV came as branded Olysio grey-market from other sources. Total price for the three DAA medicines delivered was just under $9000 USD – almost exactly your estimate.
Here in the States without insurance coverage – the branded medicines would cost nearly $440,000 – breathtaking really. Published pricing is available online at sites such as the following:
The chance of my insurance covering the costs for retreatment was zero. The current AASLD Guidelines call for deferral of treatment in my case – hardly a surprise considering the drug costs alone (even with their negotiated discounts).
My retreatment was a success – SVR4 and SVR12 were both HCV Undetected
Could not have done it without your help – the support of the FixHepC Redemption program – and all the folks here that have been my inspiration along the way.
I am forever grateful
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 UndetectedThanks GF …. I took your advice ….
Greedfighter wrote:You need to talk with Dr. Freeman, http://www.gp2u.com. He is the expert here. He will cure you.
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 UndetectedVery good advice TM ….
tweakmax wrote:U can use sof+sim+dac! (Possibly with riba also at the start of treatment to hit the virus hard)
Don’t give up!
SMV/DCV/SOF + RBV is one of the three retreatment options outlined in the 2016 EASL HCV Guidelines for those with GT1a who failed treatment with a regime containing an NS5a inhibitor (such as Viekira – PrOD).
The other two recommended therapies are Merck’s Zepatier GRZ/ELB + SOF + RBV and AbbVie’s Viekira Pak PrOD + SOF + RBV. All three call for 24 weeks of therapy.
Summarized in Table 9 / Page 36
http://www.easl.eu/medias/cpg/HCV2016/English-report.pdf
I believe these EASL Guidelines became available online just after your post here.
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 UndetectedRequiring HCV drug resistance testing prior to initial therapy is not currently advised. Dr. Freeman recently linked a study that covered some of the reasons – nicely summed up in the last paragraph below.
http://fixhepc.com/forum/resistance/1273-highly-detailed-article-on-daa-resistance.html
__________Resistance Testing Before First-Line Therapy
There are many conditions for broad use of HCV resistance tests in clinical practice.
First, a standardized assay should be available as a purchasable kit, externally validated for its performance, and easy to use routinely in any virology laboratory with experience in molecular biology. Whatever the technology used, the assay should reliably report the presence of RASs with a validated and repeatable sensitivity of 15%, equivalent to population sequencing.
Second, interpretation and reporting of HCV resistance data should be homogenized and standardized through recommendations by an international organization.
Thirdly, clinically relevant RASs should be clearly identified, and only these should be reported and used for treatment decisions.
Finally, guidelines should be provided by international societies for treatment decisions based on results of drug resistance tests. The guidelines should be based on data from clinical trials and real-life studies that reported strong predictive values of the different RAS profiles.
Because none of these conditions have yet been met, systematic testing for HCV resistance before treatment should not be recommended. Systematic testing would seriously limit access to care and lead to erroneous decisions for a number of cases. Instead, treatment can be optimized for groups of patients known to have specific RASs in NS5A that reduce response to therapy.
http://freepdfhosting.com/b3d39c5e48.pdf
__________The authors do reference the current exception for Merck’s Zepatier (elbasvir + grazoprevir) where pre-treatment NS5A resistance testing is prescribed to determine length of therapy and/or the addition of ribavirin for patients with GT1a (detail linked below).
http://www.natap.org/2016/HCV/020516_07.htm
Aside from this exception – the AASLD guidelines also recommend against resistance testing prior to initial therapy. Guidelines for retreatment – should initial therapies fail – are less concise.
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 UndetectedWhen reading this study – and then isolating the results for patients without cirrhosis and a baseline VL of < 6,000,000 who received a full 12 weeks of LDV/SOF (Harvoni) – I find that the results look very good. Table 4 shows an overall 12 week therapy SVR rate of 94.3% (1924/2040) with higher success rates in sub-groups depending on APRI and FIB-4 scoring. The best number achieved was 96.6% (875/906) in patients with both a FIB-4 of ≤ 3.25 and a baseline VL < 6,000,000 IU/ml. Looking over the health profiles of the study’s patient population – I wonder how the results would have been if the participants had received treatment earlier in their lives. With early diagnosis and treatment – the success rates might have been even better. Will add that I found the cost/benefit discussion troubling. With the stratospheric price the Veteran’s Administration pays for HCV medicines here it seems both understandable and unacceptable at the same time. 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 UndetectedHave recently made two purchases from MTO Pharma – each for costly non-generic DAA medication required for my retreatment.
Communications with MTO were very good – all questions answered promptly and with professional courtesy.
A prescription from my physician was required. Payment was made by Western Union (fees a consideration here).
Both purchases went very smoothly – shipment was made within one day of payment – MTO provided a photo of the EMS packing slip. Delivery from Ukraine to the western U.S. was exceptionally fast (both shipments arrived within one week of ordering).
Though I believe that there is a considerable risk with Customs (importing non-generic brand named medicines available within the country) – both packages were undisturbed and unopened even though labeled correctly as to content. This could be chance or current protocol – I have no way of knowing.
Thorough inspection of the delivered medication has verified authenticity. Manufacture and Expiry Dates show current production – as was promised.
For generic HCV medications – the Redemption Program through FixHepC is undoubtedly one of the very best sources. My experience with FixHepC and MonkMed has been outstanding.
For unique non-generic HCV medications – alternative suppliers must be considered – along with the associated risks.
Provided without further comment.
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 UndetectedThanks for posting this Dr. Freeman.
A quick read shows that the addition of ribavirin (RBV) to VEL/SOF when NS5A RAVs are present yields significantly better results (GT1).
I recall reading about similar trends when RBV is added to DCV/SOF – wonder if this is correct. And I also wonder if the same applies to LDV/SOF.
The GT3 results with the addition of RBV are also interesting – even considering the small number of patients.
Page 85:
Prevalence of NS5A RAVs and Impact on Treatment Outcome
In genotype 1 HCV-infected patients, the SVR12 rates in patients with or without pre-treatment RAVs were similar in the SOF/VEL+RBV 12 Week group, in contrast to the SOF/VEL 12 and 24 Week groups, where patients with baseline RAVs had lower SVR12 rates (80% and 90%) compared to patients without RAVS (96% and 98%), respectively.
Interpretation of the results in patients with genotype 3 HCV infection is limited by the small number of patients with NS5A RAVs in each treatment group. In GT3 patients without baseline NS5A RAVs, SVR12 rates were superior in the SOF/VEL/RBV group (91%) compared to the two SOF/VEL groups (60 and 50%, in the 12 and 24 week groups, respectively).
All patients with genotype 2, 4, or 6 HCV infection achieved SVR12 irrespective of the presence of pre-treatment NS5A RAVs.
__________Have had my share of RBV to be sure – and have planned to include it yet again for retreatment. Results like this seem to bolster the decision.
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 UndetectedYes TM ….
tweakmax wrote:U r the first person I know relapsed from viekira pak. Any tests done for rav?
The SVR numbers for GT1a patients treated with Vieira Pak + RBV are reportedly very good – certainly on par with Harvoni from my understanding. Unfortunately – I fell into that few percent of patients that couldn’t get it right the first time.
Had HCV drug resistance testing performed after treatment by both Monogram Biosciences (LabCorp) and Quest Diagnostics (just NS5a for the latter).
Results showed the presence of NS5a drug resistant Q30R – tested resistant/probable against all available DAA’s with the exception of velpatasvir (test was unavailable at the time). From my reading – it appears that Q30R is likely resistant to velpatasvir as well.
How each of these NS5a inhibitors perform against Q30R in practice – and when combined with other DAAs – is the subject of trials.
Very fortunately – my tests showed no NS3/4a or NS5b RAVs – most importantly no NS3 Q80K that may have precluded retreatment with simeprevir. From my reading – prevalence or the Q80K RAV varies widely by geography with North America ranking at or near the top. Over one-third of GT1a patients here reportedly test positive for Q80K. Dr. Freeman has a post on the forum that discusses this:
http://fixhepc.com/forum/experts-corner/1077-geographic-differences-between-gt-1a.html#17705
My apologies for the late response to your earlier post.
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
