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Long-Term
Treatment with Epoetin Alfa Maintains Ribavirin Dose and Hemoglobin
Levels in Anemic HCV Patients Receiving Interferon/Ribavirin
Therapy
Combination therapy (tx) with IFN
or pegylated (PEG) IFN plus RBV for chronic HCV infection
induces anemia
that may prompt RBV dose reduction or cessation. The researchers
in this study previously reported that in HCV-infected patients
(pts) receiving combination IFN/RBV tx, epoetin
alfa (EPO) maintains RBV dose and hemoglobin (Hb) levels
over a 16-week (wk) period (Afdhal et al., DDW 2003).
Additional data were collected after the initial 16-wk period
through the end of IFN/RBV tx. Although these data were not
defined in the protocol as primary or secondary efficacy variables,
the current analysis was conducted to evaluate the ability
of EPO to maintain RBV dose and Hb levels during this follow-up
period.
HCV-infected pts (N=185) who developed anemia (Hb £12 g/dL)
while receiving IFN/RBV or PEG-IFN/RBV tx were randomized
to receive once-weekly EPO 40,000 IU SC or matched placebo
(PL) with possible titration to 60,000 IU for an 8-wk double-blind
phase (DBP).
Following the DBP, eligible pts from the EPO and PL groups
received EPO for an 8-wk open-label phase (OLP). Following
the OLP, all pts were to receive open-label EPO for the remainder
of their IFN/RBV tx.
Results
As previously reported, at the end of the DBP, significantly
(P=.003) more pts in the EPO (69%) vs PL (49%) group
had RBV doses ³10.6 mg/kg/day. At the end of IFN/RBV tx, 72% of pts in the
EPO group and 69% in the PL crossover group had RBV doses
³10.6 mg/kg/day, and 84% of the total population maintained
their RBV dose compared with dose at randomization.
Mean Hb at the end of IFN/RBV tx was 12.6 ± 1.5 g/dL for both the EPO and PL crossover groups. The % HCV-RNA
undetectable in the EPO group was 58% at randomization, 65%
at wk 9, 73% at wk 17, and 72% at end of IFN/RBV.
A total of 20 serious AEs occurred during the entire study;
all but one were considered unrelated to EPO. One serious
AE (left sigmoid sinus thrombosis) was deemed possibly related
to EPO; the pt recovered without sequelae.
Conclusions
In anemic HCV-infected pts, tx with EPO through the end of
IFN/RBV tx corrected anemia and enabled 84% of pts to maintain
their RBV dose compared with randomization to EPO or PL. These
results are similar to those observed during the 8-wk DBP.
EPO was well tolerated. Follow-up data for the period following
IFN/RBV therapy are being evaluated.
The authors conclude, “Based on these results showing RBV doses
can be maintained by treating anemia with EPO, future studies
designed to evaluate the impact of EPO on the outcomes of
HCV treatment are warranted.”
05/24/04
Reference
P J Pockros and others. Long-Term Treatment with Epoetin Alfa
Maintains Ribavirin Dose and Hemoglobin Levels in Anemic HCV-Infected
Patients Receiving Interferon/Ribavirin (IFN/RBV) Therapy.
Abstract 1225 (poster). Digestive Disease Week. May 15-20,
2004. New Orleans, LA.
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