Relapsed after Viekira Pack?

[mcmaklin]

Hello,
I need your help to associate things. I have finished a month ago Abbvie Trial Viekira Pack no Riba. I am genotype 1b, TT, F1, upon start treatment I had 1400000 units of virus. After 2 weeks 120 units. After a month below the possibility of detection. After 3 months no virus.  3 weeks after treatment (I was doing tests in UK) I was undetected. Today I have received a SAD NEWS.  4 weeks after EOT I received a message from clinical trials to RETEST cause they found 27000 units. I did a retest today and am waiting. In the meantime a week ago ASPAT was 50. If this is a sad news (waiting for confirmation) is there a possibility to retreat me with Harvoni? And for how long? Where there any cases like that?  I was treatment naive. Are there any chances to be cured?

1. Do you know how to treat if it is really a relapse?
2. Do you know such case?

[Lynn K]

Hi  mcmaklin

Check out this thread related to your situation

http://forums.hepmag.com/index.php?topic=3742.msg35856;topicseen#new

Good Luck
Lynn

[KimInTheForest]

Hi McMacklin. You can also check out this link for a new clinical trial for people in your situation:
https://clinicaltrials.gov/ct2/show/study/NCT02607735

It is for people of any genotype who have relapsed after taking Sovaldi, Harvoni or Viekira.

The trial is currently recruiting. There are study locations all over US, plus Canada, UK, Australia, NZ, France.

The trial is: "Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy (POLARIS-1)"

Maybe you won't need it. Maybe the results of your retest will turn out to be good news. There has been at least one other person on these forums who has reported relapsing after successfully completing Viekira.

Good luck!
kim

[Ian]

Hi McMacklin,
sorry to hear that news. have you heard back on the retest? Did the doctors have any explanation for why these results may have occurred?

Im very curious because i'm also taking viekira with no riba, have been undetected since 1 month like you. I'm 3 weeks from being done. Are there any factors the doctors have suggested that might have led to these results?

good luck, i really hope it did not turn out to be a relapse.
Ian

[HEPful Guy]

You can try to get into the clinical trials that Gilead are performing. Or you can try retreatment with Harvoni or Sovaldi + Olysio. I wouldn't try these drugs for retreatment unless your physician has ordered a genosure ns3/4a and ns5a first to test for resistance. If he wants to start retreatment without a genosure I would probably find another doctor who understands appropriate therapy better. Your 3rd option would be to wait until the new drugs are released and all the clinical trials are over, this way your treatment can be guided by the results of the trials to optimize your drug combination and treatment length.

[Lynn K]

Here is the link from the AASLD recommendations for treatment relapse

http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed
The following is about half way down

Recommended regimen for patients in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed (including daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir plus dasabuvir).
For patients with minimal liver disease, deferral of treatment is recommended, pending availability of data.

Rating: Class IIb, Level C
 
For patients with cirrhosis or other patients who require retreatment urgently, testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below. Treatment duration of 24 weeks is recommended and, unless contraindicated, weight-based RBV should be added.

Recommended regimen for patients in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed (including daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir plus dasabuvir).
For patients with minimal liver disease, deferral of treatment is recommended, pending availability of data.

Rating: Class IIb, Level C
 
For patients with cirrhosis or other patients who require retreatment urgently, testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitors and to NS5A inhibitors is recommended. The specific drugs used in the retreatment regimen should be tailored to the results of this testing as described below. Treatment duration of 24 weeks is recommended and, unless contraindicated, weight-based RBV should be added.

Rating: Class IIb, Level C
For patients with cirrhosis or other patients who require retreatment urgently, testing for RAVs that confer decreased susceptibility to NS3 protease inhibitors (eg, Q80K) and to NS5A inhibitors should be performed using commercially available assays prior to selecting the next HCV treatment regimen. For patients with no NS5A inhibitor RAVs detected, retreatment with ledipasvir/sofosbuvir and RBV for 24 weeks is recommended. For patients who have NS5A inhibitor RAVs detected and who do not have NS3 inhibitor RAVs detected, treatment with simeprevir, sofosbuvir, and RBV for 24 weeks is recommended. For patients who have both NS3 and NS5A inhibitor RAVs detected, retreatment should be conducted in a clinical trial setting, as an appropriate treatment regimen cannot be recommended at this time.

No data are yet available on the retreatment of patients for whom prior treatment with PrOD has failed. However, studies that have evaluated patients whose virus did not respond to PrOD have reported the presence of RAVs that confer decreased susceptibly to NS3 protease inhibitors (eg, paritaprevir), NS5A inhibitors (eg, daclatasvir, ledipasvir, ombitasvir), and nonnucleoside polymerase inhibitors (eg, dasabuvir). Based on these observations, patients for whom treatment with PrOD did not result in an SVR should have HCV treatment deferred in the setting of mild liver disease, and for those with advanced fibrosis, testing for RAVs should be performed.

So basically the recommendation is if you have minimal liver damage you should wait but the best advice you should get is from your doctor.

Good luck
Lynn