Any information about ABT-450/ritonavir/ABT-267/ABT-333 w/wo Ribavirin trial?

[benjanim]

My doc offered a new phase III trial includes :

1. ABT-450
2. Ritonavir
3. ABT-267
4. ABT-333

with or without Ribavirin.


He said it is phase III trial and SVR12 rates were more than 90% .

All meds are oral and no grand side effects...

but doc couldn't show me phase II results and i could not find any information on internet.


Anyone knows this trial?

(31 yrs old, white male, naive, 1.000.000 iu/ml HCV RNA, genotype Ib)

[pooh55811]

I am going to try to post the results of the SVR chart here:

Treatment-Naive Patients

ABT -450/r + ABT-267 + ABT-333 + RBV for 8 Wks
SVR24      88%
Breakthrough     None
Relapse     10

ABT-450/r + ABT-333 + RBV for 12 Wks
SVR24      83%
Breakthrough     1
Relapse     4  

ABT-450/r + ABT-267 + RBV for 12 Wks
SVR24     89%
Breakthrough     1
Relapse     8

ABT-450/r + ABT-267 + ABT-333 for 12 Wks
SVR24      87%
Breakthrough     1
Relapse     5

ABT-450/r + ABT-267 + ABT-333 + RBV for 12 Wks
SVR24      96%
Breakthrough     0
Relapse     1

ABT-450/r + ABT-267 + ABT-333 + RBV for 24 Wks
SVR24      90%
Breakthrough     0
Relapse     2

The number of people in each group was about 80 people except for the following group which contained 41 people:
ABT-450/r + ABT-333 + RBV for 12 Wks

[benjanim]

so anyone knows difference on svr between riba and without riba arms?

[pooh55811]

AVIATOR: ABT-450/Ritonavir, ABT-267 and/or ABT-333, and RBV Achieves SVR24 Rates ≥ 90% in Treatment-Naive Patients and Previous Null Responders With Genotype 1 HCV
Source: 2013 Annual Meeting of the European Association for the Study of the Liver*

Capsule Summary     Date posted: 4/26/2013
Updated interim analysis of AVIATOR (M11-652): ongoing multicenter, randomized, open-label phase IIb study[1]


Or...... just go to this site and it will tell you about the trials and the results.

http://www.hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/4082-easl-2013-abbvie-interferon-free-combination-cures-over-90-of-hepatitis-c-genotype-1




Summary of Key Conclusions

    Treatment with 4-drug regimen of ABT-450/ritonavir, ABT-267, ABT-333, and ribavirin (RBV) for 12 or 24 weeks achieved very high sustained virologic response rates at 24 weeks posttreatment (SVR24) in noncirrhotic patients infected with genotype 1 HCV
        SVR24 rates 90% to 96% in treatment-naive patients, 93% to 95% in previous null responders
        SVR24 rates ≥ 89% in several difficult-to-treat populations, including those with HCV genotype 1a infection and non-CC IL28B genotype
        Virologic breakthrough and relapse infrequent in all groups
    4-drug regimen relatively well tolerated
        Treatment-related adverse events typically mild in severity
         50,000 IU/mL
        Treatment history
            Treatment naive: no previous HCV therapy
            Null responder: failure to achieve ≥ 2 log10 IU/mL decrease in HCV RNA following ≥ 12 weeks of treatment with peginterferon/RBV
    Exclusion criteria
        Evidence of cirrhosis
        HIV or HBV coinfection


Baseline Characteristics

    Some imbalances in baseline characteristics across arms
        2 arms had lower proportions of males compared with other arms (43% to 44% vs 56% to 63%)
        IL28B CC genotype markedly lower among null responders vs treatment-naive patients (2% to 4% vs 27% to 34%), as expected


Main Findings

    SVR24 rates ≥ 90% in both treatment-naive patients and previous null responders treated with 12 or 24 weeks of ABT-450/ritonavir, ABT-267, ABT-333, and ribavirin
        SVR12 rate among treatment-naive patients highest (99%) with 4-drug regimen for 12 weeks
        SVR12 rate among previous null responders highest (98%) with 4-drug regimen for 24 weeks
        Only 3 patients had virologic relapse between 12 and 24 weeks posttreatment
        8 patients with SVR12 data did not return for > 24 weeks and counted as virologic failures in SVR24 assessment


Among 247 patients treated with 12 or 24 weeks of ABT-450/ritonavir, ABT-267, ABT-333, and RBV, therapy relatively well tolerated

    6 patients (2.4%) discontinued study therapy for adverse events
        Events considered treatment related in 4 patients (1 event each of cholestatic hepatitis, feeling jittery, homicidal ideation, and decreased creatinine clearance)
    4 patients (1.6%) reported serious adverse events
        Events considered potentially treatment related in 1 patient (arthralgia)
    Majority of adverse events mild in severity
    No grade 4 laboratory abnormalities reported and grade 3 events uncommon, except for transient increases in bilirubin that resolved during continued therapy


I am having trouble posting the link to the capsule summary because it takes you to my logged in page. But you can register for Clinical Care Options (it is free) and then you can view all of their material, information, data, articles, etc. Type in Clinical Care Options and register.

[Boobert]

3 Words...........JUMP ON IT!!!! Just google ABT-450. Genotype 1B's are doing the best also.