TOPIC:

www.slideshare.net/mobile/ucsdavrc/on-ag...ent-of-hcv-infection

Thats interesting info for us that have had a wobble on tx.

Cheers

Thanks for posting this. Have been reading most all the material available online regarding HCV retreatment. The collection of work presented here by David Wyles MD at UCSD is interesting to be sure.

From the perspective of a patient seeking retreatment – I view information such as this as very encouraging – though academic.

Using the existing AASLD guidelines for initial therapy – medical coverage here in the States for approved HCV DAA medicines is often denied to patients without significant fibrosis scores.

Following the new and current AASLD guidelines for retreatment – “deferral of treatment” is recommended for patients who do not have cirrhosis and do not have reasons for urgent retreatment.

www.hcvguidelines.org/full-report/retrea...r-therapy-has-failed

Most any retreatment plan using approved HCV medicines here will be unavailable through medical insurance with the existing guidelines and drug costs – emphasis on the latter.

Using the flow chart shown above from Wyles’ presentation – the most basic retreatment option (no NS5A RAVs) calls for 24 weeks of Harvoni – current retail price here is just over $183,000 USD. The base retreatment option when some known NS5A RAVs are present calls for 24 weeks of Sovaldi and Olysio with ribavirin – current retail price here is over $305,000 USD.

While government agencies and insurers have negotiated significant price discounts from the drug manufacturers – these reduced prices are not available to individual patients seeking treatment.

Any realistic retreatment regiment is thereby limited to available generic medicines. This means that new drug studies – however promising – will only produce practical results sometime in the future when and if such medicines are manufactured as generics. Note that Olysio (simeprevir) – currently recommended for retreatment – has yet to become readily available as a generic.

Crossing the first hurdle for treatment has only just recently become a reality for many with the availability of generics. The second hurdle for retreatment is somewhat higher making resources such as FixHepC and access to affordable generic medicines even more important.

J

U r the first person I know relapsed from viekira pak. Any tests done for rav?

J. Eugene wrote: Thanks for posting this. Have been reading most all the material available online regarding HCV retreatment. The collection of work presented here by David Wyles MD at UCSD is interesting to be sure.

From the perspective of a patient seeking retreatment – I view information such as this as very encouraging – though academic.

Using the existing AASLD guidelines for initial therapy – medical coverage here in the States for approved HCV DAA medicines is often denied to patients without significant fibrosis scores.

Following the new and current AASLD guidelines for retreatment – “deferral of treatment” is recommended for patients who do not have cirrhosis and do not have reasons for urgent retreatment.

www.hcvguidelines.org/full-report/retrea...r-therapy-has-failed

Most any retreatment plan using approved HCV medicines here will be unavailable through medical insurance with the existing guidelines and drug costs – emphasis on the latter.

Using the flow chart shown above from Wyles’ presentation – the most basic retreatment option (no NS5A RAVs) calls for 24 weeks of Harvoni – current retail price here is just over $183,000 USD. The base retreatment option when some known NS5A RAVs are present calls for 24 weeks of Sovaldi and Olysio with ribavirin – current retail price here is over $305,000 USD.

While government agencies and insurers have negotiated significant price discounts from the drug manufacturers – these reduced prices are not available to individual patients seeking treatment.

Any realistic retreatment regiment is thereby limited to available generic medicines. This means that new drug studies – however promising – will only produce practical results sometime in the future when and if such medicines are manufactured as generics. Note that Olysio (simeprevir) – currently recommended for retreatment – has yet to become readily available as a generic.

Crossing the first hurdle for treatment has only just recently become a reality for many with the availability of generics. The second hurdle for retreatment is somewhat higher making resources such as FixHepC and access to affordable generic medicines even more important.

J

Any tests done for RAV?

U are the first person i know relapsed on viekira pak.

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 + Sofosbuvir

With the sofosbuvir as a generic for under $1000 for 12 weeks

All can be +/- ribavirin for a 4th weaker agent.

Yes 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:

fixhepc.com/forum/experts-corner/1077-ge...een-gt-1a.html#17705

My apologies for the late response to your earlier post.

J

U can use sof+sim+dac! (Possibly with riba also at the start of treatment to hit the virus hard)

Don't give up!

You need to talk with Dr. Freeman, www.gp2u.com. He is the expert here. He will cure you.

Very 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

www.easl.eu/medias/cpg/HCV2016/English-report.pdf

I believe these EASL Guidelines became available online just after your post here.

J

Thanks GF .... I took your advice ....

Greedfighter wrote: You need to talk with Dr. Freeman, www.gp2u.com. He is the expert here. He will cure you.

J

Thank 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 + Sofosbuvir

With 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:

www.goodrx.com

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

Congratulations on SVR12!

Congratulations!
The insanely high prices for these lifesaving drugs in the US is only surpassed by the insanity of the government that allows them.
m

Hi J,

I can see by your profile what you went through to beat this virus. I'm so so happy that your story has had a happy ending.

The cost of treatment that you relay is obscene and prohibitive to so many.

Coral