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Post Info TOPIC: Relapse with Sovaldi treatments
Tig


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Hello ANurse,

Welcome to the forum. I'm glad you found us! You're among some helpful and knowledgeable people and we look forward to hearing about you and how your treatment progresses.

Here is some information from the FDA consumer information website regarding the Sovaldi drug interactions and warnings. I also agree wholeheartedly with Isiscat that the use of any supplement, particularly herbal supplements are contraindicated during HCV treatment. Some can be very dangerous and in my opinion (and others) should be avoided for your safety. Supplements can interfere with treatment and the absorption of these medications. 

7.2       Potentially Significant Drug Interactions
Drug interaction information for SOVALDI with potential concomitant drugs is summarized in Table 5. The drug interactions described are based on potential drug interactions that may occur with SOVALDI. The table is not all-inclusive.

Table 5  Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interactiona

 


Concomitant Drug Class: Drug Name

Effect on Concentrationb

Clinical Comment

Anticonvulsants:
carbamazepine                    phenytoin                            phenobarbital                     oxcarbazepine

sofosbuvir
GS-331007

Coadministration of SOVALDI with carbamazepine, phenytoin, phenobarbital or oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Coadministration is not recommended.

Antimycobacterials:
rifabutin             rifampin                           rifapentine

sofosbuvir
GS-331007

Coadministration of SOVALDI with rifabutin or rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Coadministration is not recommended.
SOVALDI should not be used with rifampin, a potent intestinal P-gp inducer [See Warnings and Precautions (5.2)].

Herbal Supplements:
St. Johns wort (Hypericum perforatum)

sofosbuvir
GS-331007

SOVALDI should not be used with St. Johns wort, a potent intestinal P-gp inducer [See Warnings and Precautions (5.2)].

HIV Protease Inhibitors:
tipranavir/ritonavir

sofosbuvir
GS-331007

Coadministration of SOVALDI with tipranavir/ritonavir is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI.  Coadministration is not recommended.

 

a.         This table is not all inclusive.
b.         = decrease. 
Drugs without Clinically Significant Interactions with SOVALDI
In addition to the drugs included in Table 5, the interaction between SOVALDI and the following drugs was evaluated in clinical trials and no dose adjustment is needed for either drug: cyclosporine, darunavir/ritonavir, efavirenz, emtricitabine, methadone, raltegravir, rilpivirine, tacrolimus, or tenofovir disoproxil fumarate.

 

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/ucm377920.htm

Tig



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Tig

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Isiscat2011


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anurse1985 wrote:

I might not be in the right thread; but here goes. First, new here; hi everyone. I am on week 5 of Sovaldi/ribavirin. HCV RNA <15 at 4 week labs; > 40000000 prior to treatment in May. Should I be excited?

i have been unsuccessful in learning what OTC meds and Rx's might interfere.  I am interested in taking some Cellfood and Aquaflora (supplements) and Cranberry tablets along with some biotin. No one could tell me if they were prohibited; not my doctor, not Caremark, or the nurse line at Gilead. 

Any thoughts? 

And once the virus is undetected; are you 'home free' so to speak? I mean, once you finish treatment; is there a definitive time lapse where if you remain undetected you are 'cured'?

Diagnosed in 2000; no treatment prior to this. Genotype 2a

Welcome anurse:

I would be cautiously optimistic.  In other words hopeful but also realistic.  Obviously, the tx is working but that doesn't mean one will SVR.  Does the result read < 15 detected or <15 undetected or <15 negative or <positive?  The exact wording is important in deciphering the results; not all labs report results the same way.

I would avoid supplements during tx.  Why take the chance it could compromise tx if you don't know?

If you are still UND 12 weeks after tx has ended you will be considered SVR.  That means that, while little bits of the virus may remain your immune system should be able to deal with them, so for all intents and purposes you are considered "cured."  There are a small number of people who will relapse post SVR.  That number is disputed but may range from 1% to 23% (my guess is it is on the low end).

P.S.  I should qualify my statement regarding supplements to say that if you have a specific deficiency, such a vitamin d, you should clear that with your doc.  

 

 



-- Edited by Isiscat2011 on Wednesday 20th of August 2014 08:39:55 PM

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anurse1985


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I might not be in the right thread; but here goes. First, new here; hi everyone. I am on week 5 of Sovaldi/ribavirin. HCV RNA <15 at 4 week labs; > 40000000 prior to treatment in May. Should I be excited?

i have been unsuccessful in learning what OTC meds and Rx's might interfere.  I am interested in taking some Cellfood and Aquaflora (supplements) and Cranberry tablets along with some biotin. No one could tell me if they were prohibited; not my doctor, not Caremark, or the nurse line at Gilead. 

Any thoughts? 

And once the virus is undetected; are you 'home free' so to speak? I mean, once you finish treatment; is there a definitive time lapse where if you remain undetected you are 'cured'?

 

Diagnosed in 2000; no treatment prior to this. Genotype 2a



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Isiscat2011


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tgcd78 wrote:

3.  I don't want to start an argument, and I certainly don't plan to do this, but will alcohol or smoking marijuana "bring it back"?  

Naive questions but I'm curious.

The answer regarding alcohol is obvious and well documented: bad for our livers and could potentially "bring it back" by compromising immune responses and increasing viral replication of the little bit of virus that remains post SVR.  Personally, I wouldn't even consider it an option.  

The answer to the pot question is not as settled.  The hepatologist who treated me had an informational handout that advised patients of specific drugs/supplements not to take during tx and POT was on that list.  No big deal for me as I haven't smoked pot since way back when I was in law school (learning to uphold the law smile).  Pot has some good properties that can help people who are very sick so I hope there is more research done on this. 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
tgcd78


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mallani wrote:

3.If you're silly enough to drink alcohol after scoffing ~$150,000 worth of DAA's............................??? Pot is a bit different but I'll stay clear of this.

 

Great answer!

Someday I would like to hear your view on Pot aww



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Female 35, Genotype 1a - Completed the OPTIMIST clinical trial - sovalid (400mg)/Olysio (150mg) |  Starting VL 8mil, 3 day VL 300, 1 week viral load UND

SVR - November 14th. 2014!!!
Isiscat2011


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mallani wrote:

Sovaldi relapses seem to occur within 4 weeks of stopping the Sovaldi regime. RAV's S282T and L159F are obviously rapidly changed back to the wild-type form, as the relapsers all showed wild-type virus. This is very different from the Victrelis/Incivek relapsers, who showed dominant polymorphisms for a long time. I guess this is why Sovaldi can be reused. All RAV's will be transient, and be gone by the next round of treatment.

I'm not sure I'm buying that Sovaldi RAVs are all so transient.  If this is true then why are they claiming their next gen GS-5816 will get rid of the Sovaldi created S282T RAVs?  

Somehow it feels like some twisted pyramid scheme.  smile   I just wish they would give us honest information so we can deal with it realistically.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Gator Man


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mallani wrote:

Hi TC,

3.If you're silly enough to drink alcohol after scoffing ~$150,000 worth of DAA's ............................??? Pot is a bit different but I'll stay clear of this.

Hope you get your SVR. Naive questions are fine, but we don't have answers yet. Cheers.

There is nothing new in this article, but it summarizes the affect of alcohol with Hepatitis C in general, and the negative consequences while on Tx. It's ~$150,000 worth of DAA's and possibly shortening your life by decades. I can't undo any damage I did in this past, but the choice seems pretty obvious today.

http://inhealth.cnn.com/advances-in-treating-hepatitis-c/hepatitis-c-and-alcohol?did=t1_rss5&hpt=hp_bn13



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Geno 1b, compensated cirrhotic, 54 yo, prior null responder. Pre tx VL approx 595,000, tx with Sovaldi/Olysio (no Riba) started 1/8/14. VL 40 @ 2 weeks, UND @ 4 weeks. Still UND @ EOT + 1 year.

Gator Man SVR12, Dragon 0, Final Score.
mallani


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Hi TC,

1.According to Gilead and the Trials, 80-90% of patients are Undet. within 4 weeks of starting Sovaldi. Some patients take longer, but still get their SVR. We don't know the answer to your question about early response. It would make sense to me that rapid response would give better odds of SVR.

2.We should all aim for a healthy diet. I don't know any foods or supplements that increase the chance of SVR.

3.If you're silly enough to drink alcohol after scoffing ~$150,000 worth of DAA's............................??? Pot is a bit different but I'll stay clear of this.

Hope you get your SVR. Naive questions are fine, but we don't have answers yet. Cheers.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
tgcd78


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mallani wrote:

Sovaldi relapses seem to occur within 4 weeks of stopping the Sovaldi regime. RAV's S282T and L159F are obviously rapidly changed back to the wild-type form, as the relapsers all showed wild-type virus. This is very different from the Victrelis/Incivek relapsers, who showed dominant polymorphisms for a long time. I guess this is why Sovaldi can be reused. All RAV's will be transient, and be gone by the next round of treatment.

 

This information is interesting.  I'm in a critical period right now.  Just completed S/O 2 days ago.  These might sound like a stupid questions but perhaps you know:

1.  Does it make a difference if you are an early responder to the drugs?  

2.  Is there anything that a person could do to prevent relapse such as eat certain foods?

3.  I don't want to start an argument, and I certainly don't plan to do this, but will alcohol or smoking marijuana "bring it back"?  

Naive questions but I'm curious.



__________________

Female 35, Genotype 1a - Completed the OPTIMIST clinical trial - sovalid (400mg)/Olysio (150mg) |  Starting VL 8mil, 3 day VL 300, 1 week viral load UND

SVR - November 14th. 2014!!!
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TazKat wrote:

agree with u 100% isiscat. we have ummc a teaching hospital. the first one in the u s to actually do a heart transplant yrs ago. we got the hepa docs in at end of 2012, got to see in  2013. this area (Jackson.ms) was very very very lucky. they now have a mind center for dementia &alzheimers. which I will try to get my dad to. he has a doc but this could help a whole lot too. they are really rockin at this hospital now.

 you MntionedMind Center for Dementia and Alzheimer,, Dr Lura Frakey is my cousin , my fathers brothers side.  Google her you will find her article inserting.



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  HCV Genotype 3a , now Psot-Tx was on S/riba. First VL was 5.8 mil on 7-5-13 then "und" at 3.8 weeks. 06/13/14 still und. off meds 3 days back on 7/29 Last pill 08/10/14 SVR+4

 
mallani


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Hi all,

I'd just like to qualify my comments about the Sovaldi Trials. Starting in 2010, there were 13 Phase 1 Trials with a total of 570 patients.

The Phase 2 and 3 Trials compared a Sovaldi regime with Peg and Riba. This is OK for Geno 2 and 3, but for the Geno 1's there should have been Trials using the Victrelis/ Incivek triple.

We don't remember Trials like Fission- for Geno 3, the SVR12 rate for Sovaldi/Riba was only 56%, compared with 63% for Peg/Riba.

Zlikster: There were two others to add to OldenSlow's list. Both were Geno 1's who failed 12 weeks of Sovaldi/Riba. One repeated and achieved SVR with 12 weeks of Sovaldi/Ledipasvir.

Rob: Sovaldi is an unusual DAA. It's actually a pro-drug. In the gut, it is metabolised to two forms that are readily absorbed. One form, called GS-331007, is useless as it has no anti-HCV action- more than 90% of the ingested drug ends up as this form. The other is tightly bound to plasma, and can enter hepatocytes. Here it is changed to the triphosphate form, and is then called GS-461203. This competes for the active replication site of the HCV polymerase. It is a chain-terminator, and once incorporated, the polymerase is useless. The human body contains many polymerases, both DNA and RNA, and also mitochondrial polymerases. GS-461203 doesn't affect these, which is why Sovaldi is relatively free of side effects. Sorry this is rather obscure, but it explains why there are so many aspects of the pharmacodynamics of Sovaldi that could be influenced by other drugs or chemicals.

I'm not an organic chemist, but I'm sure more drugs will be added to the Sovaldi Precaution list.

 

Sovaldi relapses seem to occur within 4 weeks of stopping the Sovaldi regime. RAV's S282T and L159F are obviously rapidly changed back to the wild-type form, as the relapsers all showed wild-type virus. This is very different from the Victrelis/Incivek relapsers, who showed dominant polymorphisms for a long time. I guess this is why Sovaldi can be reused. All RAV's will be transient, and be gone by the next round of treatment.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
TazKat


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agree with u 100% isiscat. we have ummc a teaching hospital. the first one in the u s to actually do a heart transplant yrs ago. we got the hepa docs in at end of 2012, got to see in  2013. this area (Jackson.ms) was very very very lucky. they now have a mind center for dementia &alzheimers. which I will try to get my dad to. he has a doc but this could help a whole lot too. they are really rockin at this hospital now.



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TazKat Genotype 1A null responder x 3 riba & iterferon twice, relapsed from Incivek 2012 with only 12 weeks left to do. stage 4 mild cirrhosis 4/25/2014/ started sovaldi riba & interferon.. finished treatment 7/17/14  results 7/25  cleared..

 

 
Isiscat2011


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mallani wrote:

Hopefully, Hepatologists will still be able to customise treatments for individual patients. One size WON'T fit all..

There has been very little in the way of customizing tx for individual patients in the US to date.  It really has been one size fits all for most, despite the availability of genetic testing and fibroscans, as well as the diversity in the HepC population.  This changed to some extent when Sovaldi and Olysio were FDA approved. For 1as docs then had the choice of Int/Rib/Sovaldi, going off label with S/O, or telling their patients to wait.  The lack of customization will continue, however, as long as cost dictates both the substance and the duration of treatment.  

Another interesting thing about the US is that most HepC patients will not be treated by Hepatologists.  There simply are not enough Hepatologists to go around.  Most Hepatologists are employed in highly concentrated urban areas in teaching hospitals. The majority of HepC treatment is done in community based practices by GIs and to a lesser extent IDs.  

In reality many patients are treated by Nurse Practitioners.  NPs can even prescribe medication in some states.  My PCP told me that there is no money to be made for GIs in HepC tx and they don't tend to have an interest in the treatment of HepC as do Hepatologists.  Endoscopies and colonoscopies are where GIs make their money.  He also said GIs prefer their patients to be unconscious but he was just joking, at least one hopes. :)



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Isiscat2011


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Bills wrote:

Hearing you say they are thinking of lowering the duration to 8 weeks scares the hell out me.

The new drug application Gilead submitted for FDA approval of the S/L combo requests approval of the combo for only 8-12 weeks (or 6 weeks with a third DAA).  If this is how it actually is prescribed/approved by insurance companies I see plenty of relapses in our futures.  

Don't mean to scare you but we will need to be our own advocates with our doctors even more because our docs will be the only avenue in to getting tx time extended.  We might as well start thinking along those lines now. 

"The proposed clinical use for ledipasvir-sofosbuvir would be in treatment-naive and treatment-experienced patients with genotype 1 chronic HCV infection. It is likely that an 8-week course of ledipasvir-sofosbuvir will be used for treatment naive patients (and treatment experienced patients with prior relapse) patients, whereas a 12-week courses will be indicated for treatment experienced (partial and null responders) and patients with cirrhosis. Addition of a third direct acting agent to ledipasvir-sofosbuvir is highly effective with only 6 weeks of therapy."  http://www.hepatitisc.uw.edu/page/treatment/drugs/ledipasvir-sofosbuvir

 



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Bills


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Again and again

I can't tell you  how important all this stuff is to me. I actually think I understand Malcoms assessment of this relapse matter.  Hearing you say they are thinking of lowering the duration to 8 weeks scares the hell out me. The possibility lowering of Riba dose could be the cause of relapses.  Could that be my story? ( very possible ) no Dr's or are going fess up to that. I hope the researchers start to hear us and learn from our experiences whats not in their results. Things are getting better more success SVRs than ever before. Across all Geno types etc.    I am so grateful to this site and the people here keeping us up to date and on track. It does after a while prove to be a way for us to take charge of what we will do.    My neighbor told me he has Hep C  His doctor is suggesting Sovaldi / osiylo?    He's going to a Hematologist?  who may only be singing one song. He's not that good understanding the whole picture Geno type / Viral load / Liver results. I think it's a good shot though Geno 1/ no real symptoms / (Naive)  I said why not wait till the 1 Pill I am? It so confusing to many people. We are only a fraction of the world trying to rid ourselves of Hep C. And many us have put our bodies / livers / futures at risk hoping this next treatment will do it. For a while We are still Lab-Rats to the pharmaceutical world and victims of the insurance. Thank you Malcom and all you who can coach us through to do the best we can getting our SVR Status.  

BS



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.

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Thanks for posting this Malcolm.  It gives me a reality check.  I am on the Merck trial now and have high hopes of SVR, however I need to be realistic about outcomes.



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Long-term HCV, GT1a, IL28B C/T, T/G;  VL 2 mil.  Merck C-Edge Clinical trial  EOT 10/01/14. +24= UND
OldenSlow


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Zlikster wrote:


any Sovaldi relapsers on forum yet?

Five that I'm aware of:  Darkstar 16 wks S/O, Groupergetter 12 wks S/O, Robertsamx 16 wks Sovaldi/Riba, JLynch30 12 wks Sovaldi/Peg/Riba. And at least one who failed Sovaldi/Ledipasvir in a trial and is being retreated for longer duration.



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66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 
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Hi Malcom,

Any ideas of substances that might interfere with the action of Sovaldi? Just wondered if you have any personal thoughts on this? It looks like any antifungal affects Sovaldi. To what extent is unclear but I've been avoiding coconut oil for this very reason. After reading about Sovaldi interactions, there are a few blood pressure meds that interact also. Regarding foods, there's little information listed.

-Rob



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Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!
Isiscat2011


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Thank you for writing this, Malcolm.  I appreciate that it isn't easy to deliver this information.  Hope is a beautiful and necessary thing but it needs to be accompanied by reality.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Zlikster


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Good questions...i wonder also what can substances can interfere with absorption of Sofosbuvir.

I wonder whats the official hepatologists and insurance companies stance if there is a relapse after Sovaldi+Riba? Retreatment with Peg included or wait for another additional DAA to the mix? Is/was there any trial with Sovaldi+Riba with tx period longer than 24w? Considering the price i doubt it, but ones who can afford it, why not go for 36w on Sovaldi+Riba? Treatments indeed should be more individualized, not just per genotype.

any Sovaldi relapsers on forum yet?

cheers

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GT 3 dg. 08-2012 / FibroScan: 5 kPa F1 / FibroTest: F0-1 A1 / SoC TX: PegInt 120mcg+Riba 1000mg UND from w8 relapse EOT+4w
01-2016 Sof+Dac+Riba UND from w8, SVR24!
mallani


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It's not a great topic, but some patients are going to relapse on Sovaldi. With all the hype and glowing SVR rates from the Trials, expectations are high. It is natural to feel gutted when relapse occurs.

Results from Clinical Trials rarely translate into real world practice. Although the Sovaldi Trials appeared extensive, Gilead got away with murder. In the unseemly haste to approve Sovaldi, there were no Trials comparing Sovaldi with the SOC ( Incivek/ Victrelis + Peg. and Riba.) . We did not compare 'apples with apples'.

Sovaldi is obviously a great drug, and is the only DAA that can be re-used. Relapses are poorly understood ( or poorly explained).  As patient compliance shouldn't be an issue (1 pill/day), there is the question of drugs and substances that interfere with the absorption/action of Sovaldi. There is a current list, which will be added to.  Other than this, all relapses must be due to Sovaldi-resistant RAV's. The second line drugs have failed to control these.

When the second line drugs are Peginterferon +/- Ribavirin, many questions arise. Is the patient Interferon sensitive? We get part of the answer from the IL28B polymorphism and part from previous treatment response. There is an Interferon-response regulator at viral site NS-5A. Does Interferon response change with age, or can the virus become less Interferon sensitive? If you are TT and a prior non-responder to Interferon, it is easy to understand why you'd fail. However, CC's and prior relapsers may also fail. There's really no way of knowing. Are you Ribavirin sensitive? There are differing opinions on the correct Riba dose, the amount of Riba absorption from the gut, optimal blood levels, and the effect on RBC's. Has the patient failed previous Triple Therapy (with Incivek or Victrelis)?  Patients fail triple because the Peg/Riba can't control the RAV's. So why use it with Sovaldi? Odds are the same thing will happen. What is the best treatment duration? The answer is , unknown. The Trials suggest 12 weeks are enough for the Rx-naives and the F0-F2's. Cirrhotics need 24 weeks. This is where cost comes in. Insurance will always go for the cheapest ( read shortest) option. IMHO, patients who are not Interferon sensitive and those who have failed triple, should not be offered this Sovaldi combo.

When the second line drug/s is another DAA, the only question of interest is, can it control the Sovaldi RAV's.  So far, drugs like Ledipasvir and Daclatasvir appear to have passed this test. As both block the unstable NS-5A site, we can only hope that we don't need a third DAA to control RAV's from this site as well. Cost will be the decider for treatment length, and it worries me to see talk of 8 weeks duration or less.

Hopefully, Hepatologists will still be able to customise treatments for individual patients. One size WON'T fit all.

This obviously only applies to the Geno 1's, and ignores what may happen with Abbvie and Merck.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm
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