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Incidence and Predictors of Anemia in HCV/HIV Co-infected Subjects Treated with Pegylated Interferon and Ribavirin in A5178
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Reported by Jules Levin
CROI Feb 16-19 2010 SF
A Butt1, T Umbleja2, J Andersen2, Kenneth Sherman*3, and R Chung4
1Univ of Pittsburgh Sch of Med, PA, US; 2Harvard Sch of Publ Hlth, Boston, MA, US; 3Univ of Cincinnati, OH, US; and 4Massachusetts Gen Hosp, Harvard Med Sch, Boston, US
ABSTRACT
Background: The only approved treatment for hepatitis C virus (HCV) infection is the combination of interferon-alfa and RBV. Anemia is a major side effect of RBV and a frequent cause of dose reduction and treatment interruption. We examined the incidence and predictors of anemia in a large treatment trial of HCV/HIV co-infected persons.
Methods: A5178 was a phase II randomized, prospective trial to study whether PEG alone reduces liver fibrosis progression in subjects with HCV/HIV co-infection who had failed to achieve an early virologic response (EVR). As part of A5178 (Step 1), HCV/HIV co-infected subjects, naïve or previously nonresponsive to HCV treatment, were treated with PEG alfa-2a 180 mcg/week + weight-based RBV 1000-1200 mg/day for 12 to 18 weeks. The primary endpoint of this analysis was anemia on Step 1, defined as hemoglobin (HGB) <10 g/dL. Incidence over time was analyzed with univariate (a) and multi-covariate (b) Poisson regression adjusted for follow-up (FU) time truncated at initiation of erythropoietin (EPO), RBV dose reduction or completion of Step 1. The incidence rates are provided for 12 weeks of FU.
Results: There were 329 subjects that received PEG+RBV. Median age was 48 years; HCV viral load 6.6 log10 IU/mL; CD4+ 498 cells/mm3; HGB 14.5 g/dL at entry. Of the 329, 75 experienced anemia (26.1%); 70.7% of those were grade 1. EPO use was reported in 37% and RBV dose reduction in 50% of the 329 subjects. EVR was achieved in 48% of those with anemia and in 58% of those with no anemia (P =0.15).
Conclusions: While anemia is very common in persons who are initiated on HCV treatment, it is mostly mild. Incident anemia is associated with older age, white race, ZDV use and baseline HGB. Whenever possible, ZDV use should be avoided in persons initiating HCV treatment. Older persons, whites and those with lower baseline HGB should be monitored more carefully while on treatment.
6* subjects were on EPO at entry and were excluded ** Statistically significant with p<0.05.
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