 |
|
|
| |
Consensus Interferon for Peg/RBV Nonresponders
|
| |
| |
Reported by Jules Levin
Carroll Leevy reported results from a pilot study of high dose Consensus Interferon (IFN alfacon-1) for patients who did not respond to pegIFN plus RBV. In vitro Consensus Interferon appears more potent than IFN a or b. In this study patients started therapy with peg-IFN-a-2 +RBV. Patients who did not achieve >2 log HCV RNA reductions by 12 weeks (nonresponders) received IFN alfacon-1 15 mcg once daily plus weight based RBV for 12 weeks and then received IFNalfacon-1 15 mcg three times per week for 36 weeks (n=137). This was followed by a 24 week followup period. There were 45 African-Americans (27 men, 18 women) and 92 non African-Americans (49 men, 41 females) receiving treatment. Over 90% were genotype 1. Baseline viral load was 6.2 log copies/ml.
Doctors in the audience again came to the microphone to say they have tried high dose Consensus IFN but their patients could not tolerate it. Leevy countered by saying that 15% of patients dose reduced or took drug holidays. Growth factor was permitted. Additionally, patients were selected for this study. Only patients who were >80% adherent on PegIFN/RBV were permitted into the study. Also, patients did not wash out but were switched immediately to new interferon therapy, which may have facilitated tolerance. It appears that this therapy is for motivated patients. But Leevy said all patients completed therapy in this study. Large phase III studies are ongoing.
RESULTS
OVERALL RESPONSES TO THERAPY
WEEK 12 on IFNalfacon-1: 23% HCV RNA negative; 60% >2 log HCV RNA reduction
WEEK 24 on IFN-alfacon-1: 31% HCV RNA negative; 69% >2 log reduction
WEEK 48 on IFN-alfacon-1: 43% HCV RNA negative
WEEK 72: 37% SVR
N=137 at all time points.
HCV RNA NEGATIVE RESPONSES BY ETHNIC GROUP
WEEK 12: 13% AAs; 28% non-AAs
WEEK 24: 24% AAs; 35% non-AAs
WEEK 48: 31% AAs; 48$ non-AAs
WEEK 72: 27% SVR AAs; 41% non-AAs SVR (p=0.09)
N=137 at all time points.
Throughout time on therapy platelet count remained relatively stable. WBC counts had significant decreases. 22 patients (16%) had a reduction in WBC (ANC <0.75 x 109) that required GCSF. Hematocrit declined throughout treatment period.
Leevy concluded:
Patients who did not achieve an EVR after treatment with peg-IFN + RBV can achieve an SVR after switching to IFN alfacon-1 (15 mcg) +RBV (37%) overall for 48 weeks, Virologic reduction in HCV RNA after 12 weeks of peg-IFN-a-2 + RBV is predictive of SVR to IFN alfacon-1 (15 mcg) + RBV. African-Americans achieved an SVR of 27%, non-African-Americans achieved an SVR of 41%. Leevy said therapy was well tolerated. Further study is ongoing in phase III studies by Intermune.
|
| |
|
|
|
|
|
