Haven't heard a word about Alinia lately.

Anybody?

[eureka254]

I think most of the trial data isn't out yet.  The center near me closed trial enrollment for geno 1s back in October, so I figure we won't see any stats at least until summer/fall of this year.  (My husband's has an appt w/one of the docs running the trial on Wed., so if I have an opportunity to ask 'how it's going' I will :D.)
From a non-trial standpoint, my husband went from pre-Alinia 7.79 mil to 17.2 mil after 4 wk predose, but had a 3 log drop by week 4 and went <50 week 12, officially und week 13, but he's only in week 25 of...?  One thing the doc did say was that he had seen the post 4-wk Alinia VL spikes in the trial, but told us after we got the PCR results.
How about yourself?  I remember you going und about wk 2-3?  EOT PCR soon?
~eureka

[orleans]

drew eot blood today--kinda, we will see, jerry

[eureka254]

I'll be rooting for you, good luck, keep me posted. ~eureka

[Willy50]

http://www.kenes.com/easl2009/posters/Abstract321.htm

Session Title: LATE BREAKERS
Presentation Date: Apr 23 - Apr 25, 2009

PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF NITAZOXANIDE WITH PEGINTERFERON ALFA-2A AND RIBAVIRIN IN NONRESPONDERS (NR) WITH CHRONIC HCV GENOTYPE 1: WEEK 28 INTERIM ANALYSIS

M. Shiffman1, A. Ahmed2, I. Jacobson3, R. Pruitt4, E. Keeffe2,5
1Medicine / Hepatology, Virginia Commonwealth University Medical Center, Richmond, VA, 2Medicine / Gastroenterology, Stanford University Medical Center, Stanford, CA, 3Medicine / Gastroenterology, Weill Cornell Medical College, New York, NY, 4Nashville GI Specialists, Nashville, TN, 5Romark Institute for Medical Research, Romark Laboratories, Sausalito, CA, USA

Background and Aims: Nitazoxanide (NTZ) is undergoing study for treatment of chronic hepatitis C (CHC) and shows promising results in naïve genotype 4 patients. The antiviral mechanism of action of NTZ appears to be induction of PKR, a mediator of cellular antiviral responses. The aim of this study is to determine the efficacy of NTZ in combination with peginterferon alfa-2a (PegIFN) and ribavirin (RBV) in patients with CHC genotype 1 who are NR to PegIFN plus RBV.


Methods: Sixty-four patients with CHC genotype 1 and prior NR to PegIFN/RBV underwent 2:1 randomization in 10 U.S. centers in this double-blind, placebo-controlled study to receive either NTZ (n=42) or placebo (PBO) (n=22) twice daily over a 4-week lead-in followed by continued NTZ or PBO plus PegINF 180 mcg weekly and weight-based RBV (1000 to 1200 mg/d) for 48 weeks. Therapy was discontinued if patients failed to achieve an EVR or had detectable HCV RNA after 24 weeks of combination therapy.


Results: Mean ages (±SD) in the NTZ and PBO groups were 54 ± 8 and 53 ± 6; there were 69% and 64% men in the NTZ and PBO groups, respectively. Serum HCV RNA was measured using the Roche Cobas Taqman assay (LOQ = 50 IU/mL). Median baseline serum HCV RNA was 6.8 log10 IU/mL in the NTZ group and 6.5 log10 IU/mL in the PBO group. Analysis of data was by intention-to-treat.


Subjects                                  RVR             cEVR            EVR                HCV RNA (-) Wk 28*
NTZ+PegIFN+RBV (n=42)    2 (5%)    3 (7%)    16 (38%)      6 (14%)
PBO+PegIFN+RBV (n=22)**    0    0    5 (25%                    0

*Week 24 of combination therapy; **two subjects were prior relapsers and excluded from efficacy analysis. There were 3 SAEs; no AEs required discontinuation of treatment; and AEs were not significantly different in the two treatment groups.


Conclusions: Compared with PBO, NTZ showed modest incremental early virologic responses (cEVR and undetectable HCV RNA after 24 weeks of combination therapy). These findings may be explained by the interferon-like mechanism of action of NTZ, which account for only modest interim virologic response rates in patients proven refractory to prior interferon-based therapy.

[Willy50]

Session Title: LATE BREAKERS

Presentation Date: Apr 23 - Apr 25, 2009

PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF NITAZOXANIDE PLUS PEGINTERFERON AND RIBAVIRIN IN HCV GENOTYPE 1 PATIENTS: INTERIM ANALYSIS SHOWS INCREASE IN EVR

B. Bacon1, M. Shiffman2, J. Lim3, A. Berman4, V. Rustgi5, E. Keeffe6,7
1Medicine / Gastroenterology, St. Louis University, St. Louis, MO, 2Medicine / Hepatology, Virginia Commonwealth University Medical Center, Richmond, VA, 3Medicine / Gastroenterology, Yale University Medical Center, New Haven, CT, 4Florida Center for Gastroenterology, Largo, FL, 5Medicine / Hepatology, Georgetown University Medical Center, Fairfax, VA, 6Romark Institute for Medical Research, Romark Laboratories, Sausalito, 7Medicine / Gastroenterology, Stanford University Medical Center, Stanford, CA, USA

Background and Aims: Nitazoxanide (NTZ) is undergoing study for treatment of chronic hepatitis C (CHC) and shows complete EVR (cEVR) rates of 68% to 86% and SVR rates of 79% and 80% in naïve genotype 4 patients. The antiviral mechanism of action of NTZ appears to be induction of PKR, a mediator of cellular antiviral responses. The aim of this study is to determine the efficacy of NTZ in combination with peginterferon alfa-2a (PegIFN) and ribavirin (RBV) in naïve patients with CHC genotype 1; this is the first interim analysis of RVR, cEVR, and EVR rates.


Methods: 112 treatment-naïve patients with CHC genotype 1 underwent 2:1 randomization in 13 U.S. centers in this double-blind, placebo-controlled study to receive either NTZ (n=75) or placebo (PBO) (n=37) twice daily over a 4-week lead-in followed by continued NTZ or PBO plus PegINF 180 mcg weekly and weight-based RBV (1000 to 1200 mg/d) for 48 weeks. Serum HCV RNA was measured using the Roche Cobas Taqman assay. Discontinuation criteria include failure to achieve EVR or detectable HCV RNA after 24 weeks of combination therapy.


Results: Mean ages (±SD) in the NTZ and PBO groups were 50 ± 7 and 51 ± 8 years, respectively, and 65% of patients were men in both groups. Median baseline HCV RNA was 6.4 log10 IU/mL in the NTZ group and 6.6 log10 IU/mL in the PBO group. Analysis of data was by intention-to-treat.


TREATMENT GROUP                  RVR            cEVR          EVR
NTZ + PegIFN + RBV (n=75)    9 (12%)           45 (60%)                  60 (80%)
PBO + PegIFN + RBV (n=37)    7 (19%)           18 (49%)           25 (68%)  PCO= placebo arm

In patients with HCV RNA levels >600,000 IU/mL, cEVR and EVR rates were higher in the NTZ (n=67) vs. PBO (n=31) groups (57% vs. 39%, and 79% vs. 61%, respectively). There were 21 SAEs and no significant differences in AEs between the two treatment groups.


Conclusions: Interim results of this study in genotype 1 naïve patients with CHC shows that the addition of NTZ increases EVR rates. Moreover, these findings are consistent with the previously observed EVR results in naïve genotype 4 patients.

[eureka254]

Thanks, you're a gem!  Not earth-shattering numbers, but encouraging results for the hard to treat geno 1s.  Fast work there!
Most appreciatively,
~eureka
Now the question will be whether the SVR stats for the Alinia group remain consistent with SOC response rates for EVRs and SVRs.  The watching continues...

[orleans]

if i remember, alinia had very low relaspe rates

[springfever]

not earth shattering numbers, but I'll take all I can get.  Thanks for pointing me to this thread, eureka.

orleans, you're gonna make it buddy.  I just know it.

[kittyface]

Hi Jerry,

Next week I'm doing 12 week post tx VL.  Will let you know the results.  Here's hoping for all of us!

Best regards,

Kittyface

[sunspot]

So you both made it to the finish line!!! Way to go. I think you will both make SVR.

[kittyface]

Thanks for the well wishes -- I should know something next week.

Best regards,

Kittyface

[orleans]

Hey Sun, long time. All, had my EOT Dr. visit and old Grumpy was in a talkitive mood.(could've used more of that during tx) One thing he said that was interesting was that in the Alinia trials(which he is involved in) they were finding very low relaspe rates and if these findings held Alinia would move to the "forefront of HCV tx"  jerry

[eureka254]

orleans:  great to hear about "very low relapse rates."... it may be just 'interesting' to your ol' grumpy, but VERY exciting for this neck of the woods :)!  Wishing you the best, I'll be rooting for you.

springfever:  the SOC stats for geno1s can use every little boost!  Bodes well for those who can get to undetected...!

kittyface:  and I'll be rooting for you too!  Make sure to keep us posted.