 |
 Effect
of Baseline CD4 Cell Count on Efficacy and Safety of Pegylated Interferon plus
Ribavirin in HIV-HCV Coinfected PatientsSeveral
studies have shown that HIV positive
individuals with hepatitis C virus (HCV) coinfection experience more rapid liver disease progression
and respond less well to interferon-based
therapy than people with HCV alone. However,
data have not been consistent, and some research suggests that HIV-HCV
coinfected people with relatively well-preserved
immune function may fare as well as HCV monoinfected
individuals. Two
studied published in the January 1, 2008 Journal of Acquired
Immune Deficiency Syndromes shed further light on the association between
CD4 cell count and response to treatment with pegylated
interferon plus ribavirin. Study
1 In
the first report, researchers presented an analysis of CD4 counts and treatment
out CD4
cell data were available for 857 patients, who were included in the present analysis.
Treatment efficacy and safety were analyzed according to baseline absolute CD4
cell count and percentage of total lymphocytes. Results •
SVR rates were highest
with pegylated interferon plus ribavirin across all CD4 strata. •
With
pegylated interferon plus ribavirin,
SVR rates were independent of baseline CD4 status in genotype 2 or 3 patients. •
In
genotype 1 patients, however, SVR rates tended to be higher in patients with higher
CD4 count or CD4 percentage. •
Adverse
events and serious adverse events occurred with similar frequency among treatment
arms and CD4 count and CD4 percentage strata. •
Withdrawal
and dose reduction rates due to safety concerns were highest in patients with
a CD4 count < 200 cells/mm3. In
conclusion, the authors wrote, “[Pegylated
interferon plus ribavirin] could be effective and
well tolerated in HIV-HCV coinfected individuals with
stable HIV. With
[pegylated interferon plus ribavirin],
they added, “response tended to increase with higher CD4 counts in genotype 1
[patients]; however, because of the paucity of patients with CD4 < 200 cells/mm3,
these data require corroboration.” In their discussion, the researchers noted that APRICOT is one of
the few trials to include HIV-HCV coinfected patients
with low CD4 cell counts, as most similar studies have included people with well-controlled
HIV disease. “[N]either the efficacy nor the safety profile
of [pegylated
interferon plus ribavirin]
therapy seems to be significantly University
Hospital Zurich, Switzerland; Alfred Hospital, Melbourne, Victoria, Australia;
University of New South Wales, Sydney, Australia; University Hospital Bonn, Germany;
CHU Saint-Pierre, Brussels, Belgium; Hospital Universitari
Germans Trias i Pujol, Barcelona, Spain; University of British Columbia, Vancouver,
British Columbia, Canada; University of California, San Diego, CA; Mount Sinai
School of Medicine, New York, NY; Roche, Nutley, NJ. Study
2 In
the second study, investigators sought to determine if a baseline CD4 count ≥
350 cells/mm3 predicts sustained response to pegylated
interferon plus ribavirin. This
study looked at a multicenter cohort study of 175 HIV-HCV
coinfected patients treated for HIV in hospitals in Nice,
Results •
In patients with genotype
1, the SVR rate was 13%, and was not related to baseline CD4 cell count (odds
ratio [OR] 1.0). •
In
patients with non-1 genotypes, the SVR rate was 46%, and was not significantly
higher among those with a baseline CD4 count ≥ 350 cells/mm3
(OR 1.8). Consistent
with the results from APRICOT, the French researchers concluded that, “Higher
CD4 cell count at treatment initiation with pegylated
interferon plus ribavirin did not improve treatment
success probability, regardless of HCV genotype.”
References M Opravil, J Sasadeusz, and DA Cooper. Effect of Baseline CD4 Cell
Count on the Efficacy and Safety of Peginterferon Alfa-2a
(40KD) Plus Ribavirin in Patients
With HIV/Hepatitis C Virus Coinfection. Journal of Acquired Immune Deficiency Syndromes 47(1): 36-49.
January 1, 2008. L Valerio, Y Yazdanpanah,
I Poizot-Martin, and others. Baseline CD4 Cell Count
and Out
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