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Failure of PegIFN/RBV in People With HCV/HIV Predicted at 12 Weeks
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Mark Mascolini
ICAAC, Wash DC
November 2, 2004
A 289-person analysis of results from the APRICOT trial show that a poor response to pegylated interferon (PegIFN) plus ribavirin (RBV) at 12 weeks predicts failure to attain a sustained virologic response in people coinfected with HCV and HIV (1). The predictive prowess of 12-week trends held true for people with hard-to-treat HCV genotype 1 and for those with genotypes 2 and 3. The response at 4 weeks proved a less accurate predictor.
The prediction study involved 289 people who took PegIFN/RBV for 48 weeks in APRICOT (2) and were monitored for another 24 weeks after treatment ended. The APRICOT team defined a sustained virologic response as an HCV RNA load below 50 IU/mL 24 weeks after PegIFN/RBV therapy stopped. The researchers looked at HCV RNA levels at treatment weeks 4, 12, and 24 to see how many people had at least a 2-log (100-fold) drop in HCV load at those points. Then they figured the negative and positive predictive value of week 4, 12, and 24 responses in foretelling a sustained virologic response.
The negative predictive value jumped from 88% when the researchers used week 4 responses to 98% when they used week 12 responses. In other words, the numbers predicted with 98% accuracy that failure to achieve a 100-fold drop in HCV load at treatment week 12 foretold failure to reach and sustain a load below 50 IU/mL at week 72, 24 week after people stopped taking PegIFN/RBV. The positive predictive values at week 4 (66%) and week 12 (56%) were too low to make those numbers useful in figuring who would have a sustained response at week 72.
The APRICOT team recommends that "the optimal time to assess the negative predictive value is week 12 rather than week 4."
References
1. Rodriguez-Torres M, Dieterich DT, Lissen E, et al. Predictability of sustained virologica reponse at week 4 in HIV-HCV co-infected patients treated with peginterferon alfa-2a (40KD) (Pegasys) + ribavirin (Copegus) in the AIDS Pegasys Ribavirin Internation Co-infection Trial (APRICOT). 44th Interscience Conference on Antimicrobial Agents and Chemotherapy. October 30-November 2, 2004. Abstract H-1751.
2. Torriani FJ, Rodriguez-Torres M, Rockstroh JK, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med 2004;351:438-450.
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