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Author Topic: Harvoni’s Success in Real-World Treatment of Hepatitis C Mirrors Clinical Trials  (Read 6969 times)

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Offline Hep Editors

  • Member
  • Posts: 784
    • Hep Mag
Gilead Sciences’ hepatitis C virus (HCV) treatment Harvoni (ledipasvir/sofosbuvir) appears to work as well in real-world practice as it did in clinical trials.

Publishing their findings in the Journal of Viral Hepatitis, researchers analyzed data from a retrospective cohort study of 1,597 people with genotype 1 of hep C who were treated with Harvoni for 12 weeks in a real-world setting; 76 of them also took ribavirin.

Read more...
https://www.hepmag.com/article/harvonis-success-realworld-treatment-hepatitis-c-mirrors-clinical-trials

Offline dragonslayer

  • Member
  • Posts: 873
Good to hear!!  Anybody know what this means from the study, and why?

'After adjusting the data for various factors, the researchers found that receiving HCV care at an academic center rather than elsewhere was associated with a 44 percent reduced likelihood of achieving a cure. '
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline elias

  • Member
  • Posts: 285
Good question, Paul. Was wondering same..

Another real life study by Prime Therpeutics showed even higher SVR12 rates with Harvoni:

https://hepatitisnewstoday.com/2017/03/23/harvoni-cured-97-percent-hepatitis-c-patients-real-world-study/


Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline dragonslayer

  • Member
  • Posts: 873
Yup.. so great to read this. I remember a little earlier on some folks here were decrying the clinical results stating that they thought they were trumped up to market the drugs, and that in the real world, we'd all find out those success numbers were way overstated and that real world results could never approach those in the trials.

I guess they were wrong!
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline elias

  • Member
  • Posts: 285
Dragonslayer asked:

Quote
Good to hear!!  Anybody know what this means from the study, and why?

'After adjusting the data for various factors, the researchers found that receiving HCV care at an academic center rather than elsewhere was associated with a 44 percent reduced likelihood of achieving a cure. '

==============================

Was really curious bout the same thing . Found answer in the body of the article itself:

http://onlinelibrary.wiley.com/doi/10.1111/jvh.12611/epdf

Quote
Whereas both cirrhosis and thrombocytopenia
were inversely related to SVR12 in univariable analyses, treatment
at an academic centre took priority in the multivariable model
suggesting that it may be a more complete marker of disease status
and portal hypertensive complications than thrombocytopaenia


In other words, patients treated at academic centers tended to have more advanced liver disease. Which in general carries a higher risk for viral relapse. But considering there were only 44 viral relapses in almost 1600 patients, might be hard to generalize much from such a low failure number
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline dragonslayer

  • Member
  • Posts: 873
Good find Elias.. Thanks for that.    I guess its almost like saying, 'those patients found in kidney dialysis centers are more likely to die of kidney disease than those who arent'.
Paul

DX 2008
Started Harvoni 11/26/14 for 8 wks
Completed 8 wks Harvoni 01/20/15
EOT RNA Quant result:  Detected 29
7.5 wk post tx: Detected < LLOQ(12)
11 wk post tx: UNDETECTED SVR12
24 wk post tx: UNDETECTED SVR24; AST 26; ALT 22; ALP 73
48 wk post tx: UNDETECTED SVR48; AST 18; ALT 18; ALP 70
GT 1a
vl 2.4mil
2008 bpx: Stage&Grade 0
2013 bpx: Stage&Grade: 0-1
IL28B: TT
likely infected early '70s

Offline elias

  • Member
  • Posts: 285
Pretty similar  I guess.

Whats interesting is that this increased likelihood is apart from the cirrhosis itself. So apparently having it dealt with via academic centers was a marker for even more advanced liver disease status.

In this particular study, all patients took it for 12 weeks. In an earlier one comparing real world results to  trial studies a strong factor in viral failure was non-adherence to FDA  prescribing guidelines such as shorter duration of treatment. E.g: 8 weeks where
12 weeks was recommended. I'm guessing insurance companies played a role in that one.  So they ought to be made aware of it. Another factor in relapse in an earlier study was patient non-compliance, such as missing doses. Which somehow isn't showing up in this one. But all-in-all, what might be emerging from such studies is a profile of the risk factors for viral failure
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

 


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