jmjm treatment duration

[orleans]

Hey, Do you have the info on shortened treatment time in a form I could present to my Dr. (ie. abstracts of something) I mentioned the possibility of 24 weeks if I were to rvr and he didn't much care for that idea. thanks, jerry

[jmjm530]

This suggests ten points lower in the variable group. Not surprisingly, different studies yield different results and you really have to analyze each study carefully as to selection, pre-tx viral load, doses, etc. Best to pay for the full text versions.

Also of interest here are the *dramatic* differences in SVR in the fixed duration group -- 48 weeks -- depending on when one becomes UND. Another example of starting strong often translates into finishing strong. And another case IMO for earlier stop rules -- at week 4 -- in those that can afford to wait and treat another time.



"Treatment Length Based on Rapid Response

In the second study, Italian researchers tested the hypothesis that variable treatment duration individualized on the basis of first undetectable HCV RNA is as effective as standard 48-week treatment.

This study included 696 genotype 1 chronic hepatitis C patients treatment with either 180 mcg/week pegylated interferon alfa-2a (Pegasys) or 1.5 mcg/kg/week PegIntron plus 1000-1200 mg/day ribavirin. One group (n = 237) was treated for the standard 48-week duration. The other group (n = 459) received variable durations of treatment based on early response:

• 24 weeks if HCV RNA became undetectable at 4 weeks;

• 48 weeks if HCV RNA became undetectable at 8 weeks;

• 72 weeks if HCV RNA became undetectable at 12 weeks.

Results

• 45% of patients in the standard duration group and 49% in the variable duration group achieved SVR (P = 0.37).

• 27% first achieved undetectable HCV RNA at 4 weeks, 28% at 8 weeks, and 11% at 12 weeks.

• In the standard duration group, 87%, 70%, and 38% of patients who first achieved undetectable HCV RNA at 4, 8, and 12 weeks, respectively, achieved SVR.

• In the variable duration arm, the corresponding SVR rates were 77%, 72%, and 64%.

• Low baseline HCV RNA levels and younger age were independent predictors of rapid virological response (RVR) at week 4.

• Patients with RVR who had a high baseline viral load ≥ 400,000 IU/mL had a higher SVR rate when treated for 48 rather than 24 weeks (87% vs 73%; P = 0.14).

• The only predictive factor for SVR in patients with RVR was advanced liver fibrosis.

In conclusion, the authors wrote, “Variable treatment duration ensures SVR rates similar to those of standard treatment duration, sparing unnecessary side effects and costs.”


http://www.hivandhepatitis.com/hep_c/news/2008/010407_a.html

[jmjm530]

Here's another study on "customization" including 24 weeks for RVRs and 72 weeks for slower responders. See "conclusions" http://www.natap.org/2006/AASLD/AASLD_34.htm

Berg has also published similar.

[jmjm530]

Hi Jerry,

Anecdotally, at least from here, the shorter 24-week course of treatment doesn't seem to have taken off. People do report here that their docs are sometimes suggesting shorter treatments for geno 2's and 3's (16 or 12 weeks instead of 24) but I've only remember 2-4 people mentioning they were going to do the shorter course (24 weeks) for geno 1's. The only one that reported back the results was SVR as I remember it.

As to the studies, here's one -- they're several. This one shows the same SVR rates for 24 versus 48 if you are RVR and there may be some pre-tx viral load qualifiers, you might want to check. http://www.natap.org/2005/AASLD/aasld_55.htm

Other studies have followed and maybe you or someone will pull them out. One I remember came to the same conclusion and another gave a very good SVR rate but I believe 8 points lower than the 48 week group and I hope I'm not mixing this up with a geno 2 short-course study. But if that's the case, then maybe that's the reason it's not being endorsed unless someone is having difficulty with side effects -- but this is speculation.

Personally, if I had a low pre-tx viral load and was RVR, I'd seriously look into it more -- fetch some more studies, maybe "poll" some top docs via consults, etc. That is if you have little or no liver damage. If you have significant liver damage, then maybe best be prudent and go the full 48 weeks, because more to lose if relapse.

Good luck.

-- Jim