HIV and Hepatitis.com Coverage of the
42nd EASL Conference
April 11 - 15, 2007, Barcelona, Spain
THE EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER

AZT Can Cause Severe Anemia and Necessitate Ribavirin Dose Reduction in HIV-HCV Coinfected Patients

By Liz Highleyman

AZT (Retrovir) Capsule

Anemia is the most frequent treatment-limiting side effect of ribavirin during treatment of chronic hepatitis C. In HIV-HCV coinfected patients, use of AZT (Retrovir) may increase the risk of anemia due to synergistic toxicity.

At the 42nd Annual Meeting of the European Association for the Study of the Liver this month in Barcelona, Spain, researchers from Hospital Carlos III in Madrid presented data on the occurrence of anemia in the PRESCO trial.

PRESCO is a prospective, open-label, multicenter trial evaluating the safety and efficacy of 180 mcg/week pegylated interferon alpha-2a (Pegasys) plus 1000-1200 mg/day weight-based ribavirin. The study included 389 HIV-HCV coinfected participants: 49% with genotype 1, < 1% with genotype 2, 38% with genotype 3, and 12% with genotype 4. Most (74%) were on HAART and the mean CD4 cell count was 546 cells/mm3.

Patients with genotypes 1 or 4 received treatment for either the standard duration of 48 weeks or an extended duration of 72 weeks; those with genotypes 2 or 3 were treated for either the standard 24 weeks or an extended 48 weeks. Participants discontinued therapy if they did not achieve at least a 2-log decrease in HCV RNA by Week 12.

The mean baseline hemoglobin level was 15.5 g/dL. Severe anemia was defined as a drop in hemoglobin below 8 g/dL.

Results

  • The overall SVR rate was 49.6% in an intent-to-treat analysis.

  • Severe anemia, either isolated or in the setting of pancytopenia (reduced levels of all types of blood cells), occurred in 13 patients (3.3%).

  • Anemia was significantly more frequent among patients taking AZT (7 of 85; 8.2%) compared with those not receiving AZT (6 of 304; 2%).

  • Premature treatment discontinuation due to severe anemia also tended to be more frequent in patients taking AZT (4 of 85; 4.7%) compared with those not on AZT (5 of 304; 1.6%), but the difference did not reach statistical significance.

  • Ribavirin dose reduction was significantly more frequent among patients taking AZT (25 of 85; 29.4%) compared with those not on AZT (59 of 304; 19.4%).

  • 1 patient received erythropoietin.

  • There was no association between development of severe anemia, use of AZT, or reduction of ribavirin dosage and achievement of sustained virological response (SVR).

Conclusion

“Severe anemia was infrequent and did not impact on the achievement of SVR in this trial with the largest number of HIV-HCV coinfected patients treated with combined [pegylated interferon] and ribavirin,” the researchers concluded.

However, they added, “The use of AZT was associated with higher incidence of severe anemia and more frequent ribavirin dose reductions. Given the availability of other nucleoside reverse transcriptase inhibitors, avoidance of AZT during HCV treatment should be advised.”

04/20/07

Reference
M Nunez, M Romero, A Ocampo, and others. Impact of anemia and zidovudine use on sustained virological response in a trial of pegylated interferon plus ribavirin in HIV/HCV-coinfected patients. 42nd Annual Meeting of the European Association for the Study of the Liver. April 11 - 15, 2007, Barcelona, Spain.

 





























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