Abstract: Background: The standard of care for HCV Hepatitis is the combination of interferon ( IFN) plus Ribavirin. In HIV patients the use of this combination therapy may induce drug interactions, and reduces the adherence to HAART. The aim of this study is to evaluate safety and efficacy of a 48 weeks daily dose IFN schedule. Methods: We evaluated 50 coinfected patients; alpha IFN 2a was administered at a dose of 3 MU daily. The baseline values were the following : CD4+ 515 cells/mmc ( mean); HIV-RNA<50 copies/ ml in all patients; HCV-RNA 28, 3 x 106 copies/ ml. Results: At 48 weeks, 10 patients ( 20%) achieved a biochemical and virological response according to an intention to treat analysis. Twenty four patients ( 48%) underwent a drop-out mainly by side effects related to overlapping toxicity of interferon and antiretroviral therapy. All the patients, who responded to the treatment, showed a fast relapse one month after the end of treatment. Conclusion: Although our results demonstrated a very poor outcome and a bad tolerance to interferon monotherapy, this approach should not be dropped out, mainly in patients at high risk for side effects and in those with cirrhosis who do not tolerate or are at increased risk for the use of ribavirin.
Fast relapse and high drop out rate of 48 weeks daily interferon monotherapy in HIV-infected patients with chronic hepatitis C
BRUNO, RAFFAELE;BRUNETTI, ENRICO;FILICE, GAETANO
2002-01-01
Abstract
Abstract: Background: The standard of care for HCV Hepatitis is the combination of interferon ( IFN) plus Ribavirin. In HIV patients the use of this combination therapy may induce drug interactions, and reduces the adherence to HAART. The aim of this study is to evaluate safety and efficacy of a 48 weeks daily dose IFN schedule. Methods: We evaluated 50 coinfected patients; alpha IFN 2a was administered at a dose of 3 MU daily. The baseline values were the following : CD4+ 515 cells/mmc ( mean); HIV-RNA<50 copies/ ml in all patients; HCV-RNA 28, 3 x 106 copies/ ml. Results: At 48 weeks, 10 patients ( 20%) achieved a biochemical and virological response according to an intention to treat analysis. Twenty four patients ( 48%) underwent a drop-out mainly by side effects related to overlapping toxicity of interferon and antiretroviral therapy. All the patients, who responded to the treatment, showed a fast relapse one month after the end of treatment. Conclusion: Although our results demonstrated a very poor outcome and a bad tolerance to interferon monotherapy, this approach should not be dropped out, mainly in patients at high risk for side effects and in those with cirrhosis who do not tolerate or are at increased risk for the use of ribavirin.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.