The incidence, predictors and management of anaemia and its association with virological response in HCV / HIV coinfected persons treated with long-term pegylated interferon alfa 2a and ribavirin

Abstract

Background: The association of anaemia with outcomes in the HCV/HIV coinfected persons undergoing HCV treatment remains unclear.

Aims: To study the incidence, predictors and management of anaemia, and its association with outcomes among persons treated with pegylated interferon and weight-based ribavirin.

Methods: Retrospective analysis of a prospective controlled treatment trial of HCV/HIV coinfection.

Results: Among 329 subjects enrolled, 40% developed anaemia during the first 12-18 weeks of treatment (median haemoglobin decrease at week 4: 2.2 g/dL). Among 169 subjects who achieved early virological response and received therapy for 72 weeks, 55% eventually developed anaemia. However, median haemoglobin levels stayed stable after 12-18 weeks of initial therapy. Among these 169 subjects, 45% were prescribed an erythropoiesis stimulating agent (ESA), with 17% receiving it prior to a drop in haemoglobin meeting protocol definition of anaemia. Only 27% completed the study without any ribavirin dose modification. Age >40 years, lower BMI, zidovudine use and lower entry haemoglobin were significant predictors of anaemia in the multi-covariate model. Among all 329, sustained virological response (SVR) rate was similar in those with or without anaemia (23% vs. 30%; P=0.17) with no evidence of association between anaemia or ESA use and treatment response.

Conclusions: Anaemia is common in HCV/HIV coinfected persons undergoing HCV treatment, and only a minority of them are able to maintain ribavirin dose. Persons with age >40 years, lower baseline haemoglobin and lower baseline BMI should be monitored carefully. Prescription of erythropoiesis stimulating agent is common, but anaemia or erythropoiesis stimulating agent use is not associated with SVR.

© 2011 Blackwell Publishing Ltd.

Figures

Figure 1

The schema for A5178 study.

Figure 2

(a) Time to anaemia (Step 1). (b) Time to anaemia (Steps 1 + 3). Follow-up was censored at the initiation of an erythropoeisis stimulating agent, ribavirin dose reduction or discontinuation. Step 1 refers to all subjects who entered the trial (N = 329); Step 3 refers to subjects who completed at least 12 weeks of therapy, demonstrated an early virological response defined as a drop in HCV RNA of at least 2 log10 at week 12, and were assigned to continue treatment with pegylated interferon and weight-based ribavirin for a total of 72 weeks.

Figure 3

Change in haemoglobin from study entry. * Medians with interquartile range are plotted at each time point. Step 1 refers to all subjects who entered the trial (N = 329); Step 3 refers to subjects who completed at least 12 weeks of therapy, demonstrated an early virological response defined as a drop in HCV RNA of at least 2 log10 at week 12, and were assigned to continue treatment with pegylated interferon and weight-based ribavirin for a total of 72 weeks.

Figure 4

Change in haemoglobin among subjects who entered Step 3, by gender. * Medians with interquartile range are plotted at each time point. ** FUP0, FUP12, FUP24 are follow-up visits at 0, 12 and 24 weeks after treatment discontinuation respectively.

Figure 5

Anaemia on Step 1 and response to treatment. * EVR = early virological response defined as at least a 2 log10 drop from HCV RNA from entry or undetectable (