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Reuters Health Information (2007-08-23): REFILE: Early response to hepatitis C treatment predicts outcomes in HIV co-infected patients


REFILE: Early response to hepatitis C treatment predicts outcomes in HIV co-infected patients

Last Updated: 2007-08-23 8:25:32 -0400 (Reuters Health)

[Refiles item 20070815clin009 originally posted August 15, 2007, to correct "UI/mL" to "IU/mL" in 6th paragraph.]

NEW YORK (Reuters Health) - Early and rapid virological response of chronic hepatitis C virus (HCV) infection to treatment with interferon and ribavirin predicts sustained virological response in patients co-infected with HIV and HCV, according to findings published in the August issue of Gut.

"The current standard recommendation is to quantify HCV RNA at week 12 to evaluate the decrease of HCV RNA since the initiation (D0) of the treatment," Dr. Francoise Lunel-Fabioni from CHU Angers, France told Reuters Health. "However, it is difficult to distinguish sustained responders and relapsers at this time because of the low level of viral load in the majority of relapsers. With a more sensitive assay, we may discriminate these two groups and increase the positive predictive value of undetectable (<12 IU/mL) HCV RNA and decrease of viral load since D0."

Dr. Lunel-Fabioni and colleagues in the ANRS HC02 RIBAVIC study team evaluated the usefulness of HCV RNA measurements in patients co-infected with HCV and HIV and investigated whether early variations in HCV RNA could accurately predict eventual treatment response to an interferon-based regimen plus ribavirin.

The decrease in HCV RNA at week 2 of treatment was significantly greater in sustained responders to pegylated interferon plus ribavirin than in relapsers and nonresponders, the authors report.

The best positive predictive value of response to treatment was obtained using undetectable HCV RNA at week 4 and with more than a 2log10 decrease at week 12, the report indicates -- and most responder patients had undetectable HCV RNA at week 12.

Almost all of the non-sustained virologic response patients had detectable HCV RNA at week 4, the investigators say, but the best negative predictive value of response to treatment was obtained at week 12 using a cut-off HCV RNA level above 39,000 IU/mL.

Based on these findings, the researchers propose a new algorithm for HIV/HCV co-infected patients treated with PEG-interferon-alpha-2b and ribavirin based on rapid virologic response and early virologic response marker cut-off levels at week 4, week 12, and week 24, irrespective of HCV genotype.

Early detection of non-sustained virologic response patients would produce substantial cost savings, as 1 year of PEG-interferon plus ribavirin therapy costs 16,000 euros per patient, the investigators conclude.

"Longer treatment is needed for co-infected patients," Dr. Lunel-Fabioni pointed out. "Relapsers are in fact slow responders and must be treated longer."

The investigator added that further studies will investigate the utility of a more sensitive test for HCV RNA and the effectiveness of longer treatment after HCV RNA is no longer detectable.

Gut 2007;56:1111-1116.

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