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Boceprevir or Telaprevir?
Hi everyone! I haven't been on here in a long time, but I am considering starting treatment now and I have a question. First of all, my doctor recommended Boceprevir over Telaprevir because she says she "thinks" Boceprevir is more effective and reduces Tx time more than Telaprevir does. I know there are a lot of very knowledgable people on here that I can trust so I was wondering what you thought about that. I honestly have not spent a lot of time researching this topic. It does seem as though Telaprevir is more popular for whatever reason though.
Anyways, quick background on me: I was diagnosed 2 years ago with genotype 1a. I've probably had the virus for 7-8 years from IV drug use. I haven't had any labs done in about a year or so, but my VL has always been extremely low, so low once that it was undetectable. The highest it has been is a little over 13,000. I had a biopsy about a year and a half ago (when I was first considereing Tx) which came back great. No fibrosis. Because of that I decided to wait for the new meds to come out.
Anyways, quick background on me: I was diagnosed 2 years ago with genotype 1a. I've probably had the virus for 7-8 years from IV drug use. I haven't had any labs done in about a year or so, but my VL has always been extremely low, so low once that it was undetectable. The highest it has been is a little over 13,000. I had a biopsy about a year and a half ago (when I was first considereing Tx) which came back great. No fibrosis. Because of that I decided to wait for the new meds to come out.
" Wouldn't I still have to go through the 48 weeks without it?"
No. As willbb posted, there's no significant difference between 24 and 48 - provided you're UND at week 4 - given a low viral load and little to no damage. The Europeans have been using this protocol for geno 1s for years. But there is no gaurantee you'll be UND at week 4, in which case you go ahead with the PI. But given the fact that the PIs have caused the % of people who have to discontinue tx entirely to roughly double (from 4% to 6-8%) it's an approach I'd give some serious thought to.
No. As willbb posted, there's no significant difference between 24 and 48 - provided you're UND at week 4 - given a low viral load and little to no damage. The Europeans have been using this protocol for geno 1s for years. But there is no gaurantee you'll be UND at week 4, in which case you go ahead with the PI. But given the fact that the PIs have caused the % of people who have to discontinue tx entirely to roughly double (from 4% to 6-8%) it's an approach I'd give some serious thought to.
Genotype 1 Chronic Hepatitis C Patients with Low Viral Load Can Achieve Sustained Response with 24 Weeks of Pegylated Interferon plus Ribavirin
SUMMARY: Final results from the PREDICT study showed that genotype 1 chronic hepatitis C patients with low baseline viral load and rapid virological response at week 4 can achieve good outcomes with just 24 weeks of pegylated interferon plus ribavirin, researchers reported at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2009) this month in Boston.
By Liz Highleyman
Standard therapy for chronic hepatitis C virus (HCV) infection consists of pegylated interferon plus ribavirin for 24 weeks in patients with HCV genotypes 2 or 3, and for 48 weeks in patients with hard-to-treat genotype 1. But the shorter treatment duration may be adequate for certain genotype 1 patients with favorable characteristics.
PREDICT was a Phase 4 open-label post-marketing study conducted in Europe to evaluate shortened therapy for treatment-naive genotype 1 patients with low baseline viral load (< 600,000 IU/mL) and rapid virological response (RVR), or undetectable HCV RNA at week 4 of therapy. A majority of participants (62%) were men, most (97%) were white, the mean age was about 38 years, and the mean estimated duration of HCV infection was 13 years.
A total of 187 enrolled participants were treated with 1.5 mcg/kg/week pegylated interferon alfa-2b (PegIntron) plus 800-1200 mg/day weight-based ribavirin. Patients who had undetectable HCV RNA at week 24 were given the option to stop therapy at that point, and were followed for 24 weeks post-treatment.
Results
93% of participant completed the study.
3% were lost to follow-up, 2% discontinued due to adverse events, 2% elected not to continue, and 1% did not meet eligibility requirements.
In an efficacy analysis of 170 patients, the sustained virological response (SVR) rate was 87.6% and the relapse rate was 9.7%.
In a per-protocol analysis of 156 patients, the SVR rate was 90.4% and the relapse rate was 9.6%.
Looking at 153 patients who were deemed adherent to therapy, the corresponding rates were 90.8% and 9.2%, respectively.
14% of participants reported adverse events.
The most common side effect was flu-like symptoms, reported by 3%.
Based on these findings, the PREDICT investigators concluded, "In HCV genotype 1 low viral load treatment-naive subjects who attain RVR, pegylated interferon alfa-2b and weight-based ribavirin for 24 weeks is well-tolerated and results in a high rate of SVR with a low likelihood of relapse."
http://www.hivandhepatitis.com/2009icr/aasld/docs/111709_a.html
SUMMARY: Final results from the PREDICT study showed that genotype 1 chronic hepatitis C patients with low baseline viral load and rapid virological response at week 4 can achieve good outcomes with just 24 weeks of pegylated interferon plus ribavirin, researchers reported at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2009) this month in Boston.
By Liz Highleyman
Standard therapy for chronic hepatitis C virus (HCV) infection consists of pegylated interferon plus ribavirin for 24 weeks in patients with HCV genotypes 2 or 3, and for 48 weeks in patients with hard-to-treat genotype 1. But the shorter treatment duration may be adequate for certain genotype 1 patients with favorable characteristics.
PREDICT was a Phase 4 open-label post-marketing study conducted in Europe to evaluate shortened therapy for treatment-naive genotype 1 patients with low baseline viral load (< 600,000 IU/mL) and rapid virological response (RVR), or undetectable HCV RNA at week 4 of therapy. A majority of participants (62%) were men, most (97%) were white, the mean age was about 38 years, and the mean estimated duration of HCV infection was 13 years.
A total of 187 enrolled participants were treated with 1.5 mcg/kg/week pegylated interferon alfa-2b (PegIntron) plus 800-1200 mg/day weight-based ribavirin. Patients who had undetectable HCV RNA at week 24 were given the option to stop therapy at that point, and were followed for 24 weeks post-treatment.
Results
93% of participant completed the study.
3% were lost to follow-up, 2% discontinued due to adverse events, 2% elected not to continue, and 1% did not meet eligibility requirements.
In an efficacy analysis of 170 patients, the sustained virological response (SVR) rate was 87.6% and the relapse rate was 9.7%.
In a per-protocol analysis of 156 patients, the SVR rate was 90.4% and the relapse rate was 9.6%.
Looking at 153 patients who were deemed adherent to therapy, the corresponding rates were 90.8% and 9.2%, respectively.
14% of participants reported adverse events.
The most common side effect was flu-like symptoms, reported by 3%.
Based on these findings, the PREDICT investigators concluded, "In HCV genotype 1 low viral load treatment-naive subjects who attain RVR, pegylated interferon alfa-2b and weight-based ribavirin for 24 weeks is well-tolerated and results in a high rate of SVR with a low likelihood of relapse."
http://www.hivandhepatitis.com/2009icr/aasld/docs/111709_a.html
*nausea is the scariest side effect after anemia I should say.
Also my anemia isn't usually too serious. Doesn't it also effect WBCs and platelets? If so those are usually low for me too.
Also my anemia isn't usually too serious. Doesn't it also effect WBCs and platelets? If so those are usually low for me too.
Lots to think about! Thank you everyone. I should add here that I am usually anemic as it is, so that side effect is a big concern. However, it seems as though more people experience nausea with Incivek. That for me is probably the scariest symptom. Plus the rash and anal pain don't sound too pleasant either.
dsrt and willbb: Not using a PI at all is a thought. I think there is a very good chance that the virus would be undetectable after 4 weeks of peg/riba. I thought that adding inc or vic would make the treatment time shorter though? Wouldn't I still have to go through the 48 weeks without it?
I don't know if I would want to wait for newer treatment options. I was thinking I might try to have another baby if possible in the next few years and if I don't get rid of this virus now then that's not an option. I know the chances of giving this to the baby are small (both children I had before I knew I had Hep C do not have it), but I still don't want to take that chance.
dsrt and willbb: Not using a PI at all is a thought. I think there is a very good chance that the virus would be undetectable after 4 weeks of peg/riba. I thought that adding inc or vic would make the treatment time shorter though? Wouldn't I still have to go through the 48 weeks without it?
I don't know if I would want to wait for newer treatment options. I was thinking I might try to have another baby if possible in the next few years and if I don't get rid of this virus now then that's not an option. I know the chances of giving this to the baby are small (both children I had before I knew I had Hep C do not have it), but I still don't want to take that chance.
desrt ..brings up a good point . Having a low VL(especially if it is <200,000 ) being of younger age,low body weight and no fibrosis are all predictors of attaining an RVR( no virus at week4) doing just Peg/Riba.
With an RVR data shows the chances of success are approx. 85 -90% without adding the third drug (and studies show that no significant difference in those circumstances doing 24 or 48 weeks)
Also ...have you and your doctor discussed waiting to treat until possibly even better modalities are available(there are many drug companies experimenting currently with" Inteferon free" treatments),that may be on the market in the next few years?
Being you are young and and have possibly only been infected for 7 years or so and have no liver damage ..this certainly might be something to consider...
Best to you on any decison you make.......
Will
80mecheng:
There is significant data given the thousands that participated in many trials over a span of approx. 8 years. There was "no " difference in "drop out" rates " due to "adverse events" of either drug ..... 13 vs. 14 %
Fourteen percent of subjects discontinued INCIVEK due to adverse drug reactions. Rash, anemia, fatigue, pruritus, nausea, and vomiting were the most frequent adverse drug reactions leading to discontinuation of INCIVEK
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256328.htm
During the entire course of treatment, the proportion of subjects who discontinued treatment due to adverse reactions was 13% for subjects receiving the combination of VICTRELIS with PegIntron/REBETOL
. Events resulting in discontinuation were similar to those seen in previous studies with PegIntron/REBETOL.
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm255413.htm
80meching:
It should be noted that we are basically less than a year into the usage of either drug so our understanding is incomplete IMO.
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The data is very complete from the thousands of patients that took part in carefully analyzed trials over approx. 8 years
And the fact is that there was" no "difference between either drug for their "drop out "rate .
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