Aa
14 Weeks Not Inferior to 24 Weeks For Geno 2's and 3's Who are RVR.
Thought the study "Shastri" posterd below was worth quoting in part. Of note is that they used something termed an "inferiority" margin of 10% and a "significance factor of 5% to come to their conclusion that 14 weeks is non-inferior to 24 weeks.
RVR was defined as being non-detectible at week 4 to a sensitivity of 50 IU/ml. No doubt the figures might even be better for the 14-week group if a more sensitive test was used -- say 5 IU/ml -- but this is just my personal speculation. Also of note is that
while the 24 week group did have 6.7% better rate of SVR, that group still had 81% SVR.
Of equal importance is that if you only compared the "per protocol" groups", meaning those that took 80% of their meds 80% of the time, then there was only a difference of 4%, where 91% of the 14 week group achieved SVR.
Two other things: the group used Peg Intron as opposed to Pegasys, where the results may or may not be better. And this is a European population, that sometimes does better in trials although not sure if that holds true with geno 2's and 3's or just geno 1's.
Cont...
RVR was defined as being non-detectible at week 4 to a sensitivity of 50 IU/ml. No doubt the figures might even be better for the 14-week group if a more sensitive test was used -- say 5 IU/ml -- but this is just my personal speculation. Also of note is that
while the 24 week group did have 6.7% better rate of SVR, that group still had 81% SVR.
Of equal importance is that if you only compared the "per protocol" groups", meaning those that took 80% of their meds 80% of the time, then there was only a difference of 4%, where 91% of the 14 week group achieved SVR.
Two other things: the group used Peg Intron as opposed to Pegasys, where the results may or may not be better. And this is a European population, that sometimes does better in trials although not sure if that holds true with geno 2's and 3's or just geno 1's.
Cont...
"...Results
* Overall, 298 of 428 patients (70%) achieved RVR and were randomized to Group A (n = 149) or Group B (n = 149).
* The median age was 38 years, 65% were men, the mean weight was 80 kg, 20% had genotype 2, and 80% had genotype 3.
* There was no significant difference in the baseline characteristics of the 2 groups.
* In an intention-to-treat analysis, SVR was observed in 121 of 149 patients (81%) in Group A and in 131 of 149 patients (88%) in Group B.
* The difference between the 2 groups was 6.7%.
* In a per protocol analysis including only those who received more than 80% of each drug for more than 80% of the scheduled time and who had HCV RNA measured 24 weeks post-treatment, 115 of 127 patients (91%) in Group A and 95 of 100 patients (95%) in Group B achieved SVR.
Conclusion
Based on their findings, the study authors concluded,
* Overall, 298 of 428 patients (70%) achieved RVR and were randomized to Group A (n = 149) or Group B (n = 149).
* The median age was 38 years, 65% were men, the mean weight was 80 kg, 20% had genotype 2, and 80% had genotype 3.
* There was no significant difference in the baseline characteristics of the 2 groups.
* In an intention-to-treat analysis, SVR was observed in 121 of 149 patients (81%) in Group A and in 131 of 149 patients (88%) in Group B.
* The difference between the 2 groups was 6.7%.
* In a per protocol analysis including only those who received more than 80% of each drug for more than 80% of the scheduled time and who had HCV RNA measured 24 weeks post-treatment, 115 of 127 patients (91%) in Group A and 95 of 100 patients (95%) in Group B achieved SVR.
Conclusion
Based on their findings, the study authors concluded,
The opening paragraph 'pegylated interferon alfa-2a (PegIntron) plus ribavirin'. Unless I'm just tx-impaired, Pegintron is 2B and Pegasys is 2A.
Good eye. No doubt that was the editor's (Ronald Baker) mistake as Peg Intron is mentioned both in the heading and througout. Of course, anyone following the shortened protocol might be advised to get hold of the full-text study/presentation to present to their doctor.
-- Jim
-- Jim
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
