[Sovaldi+Riba] RNA: virus detected after undetected during therapy

[Kyle]

Hello everyone . My mother started with Sovaldi + Riba in March. Genotype 2, 24 weeks therapy, F4, naïve. So, HCV RNA test showed an undetected virus in week 6 and again in week 8. Everything was fine. But in week 12, RNA was <12 BUT detected (AST 28 ALT 24, lowest ever). So I searched similar cases but without success. Now I’m wondering: what may have happened? I thought that during Sovaldi therapy virus can’t return. Also, I can’t understand if that result may influence therapy efficacy and the EOT. Anyone had a similar situation? Thank you.

[lporterrn]

This is fairly common, and people largely still have an SVR. In fact, it is so common, that some doctors are not testing at week 12. The result should not change a thing. The ALT is highly encouraging, and if the virus was returning, the ALT and viral load would be much, much higher.

[TexasC+]

My insurance insisted on  viral load at 4 weeks. Will get the results in a few days. I have my fingers crossed

[lporterrn]

They can insist, and it is their money they are spending. While you are crossing your fingers, here is the only reason why treatment should be discontinued based on week 4 viral load results:

Prompt discontinuation of therapy is recommended for any a) 10-fold increase in alanine aminotransferase (ALT) activity at week 4; or b) any increase in ALT of less than 10-fold at week 4 that is accompanied by any weakness, nausea, vomiting, or jaundice, or accompanied by increased bilirubin, alkaline phosphatase, or international normalized ratio. Asymptomatic increases in ALT of less than 10-fold elevated at week 4 should be closely monitored and repeated at week 6 and week 8.

[Kyle]

This is fairly common, and people largely still have an SVR. In fact, it is so common, that some doctors are not testing at week 12. The result should not change a thing. The ALT is highly encouraging, and if the virus was returning, the ALT and viral load would be much, much higher.

Thanks. So is it common a 'detected' after two 'undetected', still under treatment? That's weird. Actually I read that with IFN free therapies some doctors detected a 'trace' at EOT in fully cured patients and they suppose that the 'trace' is a group of 'dead' virus released by hepatic cells without their replication capacity (sorry for bad explanation, I'm italian ). Now, I read similar cases with Harvoni (on this forum too) but I can't find anything with Sovaldi+Riba therapy and, above all, I don't know if this can happen DURING therapy (our EOT will come in september). Should we repeat RNA asap with fingers crossed? BTW, ALT was between 30-24 since week 4 (pre-therapy: between 220-120).

My fear is that the virus may have created a 'resistance' against Sovaldi. But is it possible?

[Lynn K]

Viral testing on treatment is of little value all it does is just as in your case frighten the patient unnecessarily. The only test that matters is the 12 week post treatment result and you have many weeks to go on treatment.

I have not read anything about sovaldi resistance in fact I have read that sovaldi does NOT result in resistance issues.

Looking at the Fission clinical trial results I see for genotype 2 with cirrhosis treated for 12 weeks with riba and Sovaldi 83% (10/12) were cured. While in the Positron clinical trial 94% (16/17) of GT 2 with cirrhosis treated for 12 weeks Sovaldi and Riba were cured

Just take a deep breath and stay the course your mom will be cured hang in there

wishing you the best
Lynn

[Kyle]

Viral testing on treatment is of little value all it does is just as in your case frighten the patient unnecessarily. The only test that matters is the 12 week post treatment result and you have many weeks to go on treatment.

I know that with IFN therapy the viral load was crucial but, yeah, I also heard that with all oral tx everything has changed and the viral testing is not that important during treatment (neither early 'negative', am I right?). Still an unexpected value for us. The problem is: while our doc said that it's still a 'negative' value, the lab told us that the trace wasn't detected in past tests, so there ARE again some nasty (dead?) guys in there. That's why I'm so confused now  .

I have not read anything about sovaldi resistance in fact I have read that sovaldi does NOT result in resistance issues.

Actually... I read that too. You know, we are so naive with Sovaldi treatment (in our contry is available since February/March [2015!]) and we have just a few information. So I searched through, well, the whole internet and I found that the resistance with Sofosbuvir is very unlikely (impossible?)... but I wasn't sure at all.

Looking at the Fission clinical trial results I see for genotype 2 with cirrhosis treated for 12 weeks with riba and Sovaldi 83% (10/12) were cured. While in the Positron clinical trial 94% (16/17) of GT 2 with cirrhosis treated for 12 weeks Sovaldi and Riba were cured

I read all the trials, of course, and I thought that with our 'custom' treatment (24 weeks instead of 12-16 weeks, but only 600-800 mg of Riba instead of 1000 mg) we should have high cure rate (around 90%?). Or... at least we hope so.

Just take a deep breath and stay the course your mom will be cured hang in there

Thanks for your kind answer and for great support... I hope you're right about 'mamma mia' .

[Kyle]

Update: at week 13... AST 44 ALT 28... and now I'm worried for that increase (especially ALT, last time: AST 28 ALT 24). What do you think?

[TexasC+]

Since the holiday weekend they drew my 4 week viral load at 3 weeks and 4 days. It was 200. My initial was 7 million alt and ast are normal and lower then the 2 week . I started out with alt and ast in the 200's. H and H UP !!! Great at 14.5
My doc o all should be good.
I am now on once a month labs and visits . 19 weeks to go .

[Kyle]

Hi, here I am again. We're approching to EOT (last pills tomorrow of a 24 weeks naive sovaldi+ribavirin, genotype 2 F4 therapy), until now we still have the 'not detected' at week 20 and ALT and AST between 24-33, but last week we had some strange values: AST 42 ALT 38 GGT 41 (last month AST 33, ALT 27, GGT 31). Other values are ok (ALP, AFP, albumin, bilirubin and platets too).

On week 23 I refuse to think that virus can be returned, I mean I NEED to think we haven't waste time and energy (and hope), so I'm wondering: what happened? Maybe it's just some bad digestion? The previous evening she ate milk with some cereals, actually I read that could not be the perfect meal before blood test.

[lporterrn]

Unless she poured alcohol on her cereal, then what she ate would not affect her tests.Tine will tell, and I wish you the best.