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End
of Treatment Response for PEG-IFN + Weight-Based Ribavirin
Nonresponders Retreated with Consensus Interferon Plus Ribavirin
Recent studies suggest that consensus interferon (IFN alfacon-1;
Infergen) with ribavirin (RBV) may be effective in re-treating
interferon alfa and RBV non-responders when compared to re-treatment
with a PEG-IFN-alfa 2 containing regimen.
In this report, investigators review the end of treatment virological
response and safety of IFN alfacon-1 and weight based ribavirin
in HCV patients who were non-responders to PEG IFN alfa-2b
(PEG-Intron) and weight based ribavirin.
The researchers conducted a retrospective review of 137 consecutive
PEG IFN alfa-2b/RBV non-responders re-treated with daily IFN
alfacon-1 and RBV. All patients had previously received PEG
IFN alfa-2b 1.5 mcg/kg SQ Q week and weight based dosed RBV,
and did not have at least a 2 log decline in HCV RNA at week
12 of therapy (Null Responders).
With no washout period, patients were started on IFN alfacon-1
at 15 mcg SQ daily and RBV 1000-1200mg QD for 12 weeks; if
they were HCV RNA negative the dose was reduced to 15 mcg
SQ TIW for the remainder of the 48 weeks, if they were not
HCV RNA negative, no dose reduction was implemented.
Patients were monitored for constitutional symptoms and blood
was collected for serum chemistries and hematological evaluations.
Results
The population was 57% male, mean age was: 47.5 ± 9 years, mean weight was 79 ± 15 kg. Ninety-five
percent of the patients were HCV genotype 1 and 4. The mean
HCV RNA at baseline and after 12 weeks of therapy of PEG IFN
alfa-2b /RBV was 3.245 ± 4.11 million copies/ml, and 1.67 ± 1.82 million copies/ml.
At
the end of 12 and 24 weeks of therapy with daily IFN alfacon-1/RBV,
the mean HCV RNA was 247,000 ± 314,000 copies/ml and 189,902 ± 254,500 copies/ml respectively, a significant reduction from
the baseline (P<0.05 for both observations).
By the end of therapy with IFN alfacon-1/RBV (week 48) 59/137
(43%) of patients were HCV RNA negative.
Therapy was well tolerated in all patients with flu-like symptom
and fatigue reported in most patients, but no patients discontinued
therapy.
Sixteen percent (22 patients) had ANC drop below 0.75 X 109
/L, and required growth factors.
Conclusions
The authors conclude, “In these difficult to treat non-responding
HCV patients, retreatment with bio-engineered IFN alfacon-1/RBV
resulted in a clinically significant end of treatment virologic
response (43%). Patients will be monitored for HCV RNA response
6 months post treatment to determine the rate of SVR.”
“These initial data are highly promising and warrant more study
of IFN alfacon-1/RBV in difficult to treat chronic hepatitis
C patients.”
05/17/04
Reference
C B Leevy and others. End of Treatment Response for PEG-IFN
+ Weight-Based Ribavirin Nonresponders Retreated with IFN
alfacon-1 + Weight-Based Ribavirin. Abstract S1165 (poster). Digestive Disease Week
2004. May 15-20. New Orleans, LA.
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