1073 
On-treatment Responses at Weeks 4 and 12 Can Be Used to Predict Sustained Virological Response Rates in HCV/HIV-co-infected Patients Treated with Peg-Interferonbeta-2a and Ribavirin
M Rodriguez-Torres1, Juergen Rockstroh*2, J Depamphilis3, G Carosi4, D Dieterich5, and F Torriani6
1Fndn de Investigacion de Diego, Santurce, Puerto Rico; 2Univ of Bonn, Germany; 3Roche, Nutley, NJ, US; 4Univ Degli Studi di Brescia, Italy; 5Mt Sinai Sch of Med, New York, NY, US; and 6Univ of California, San Diego, US
Background: Hepatitis C virus (HCV)
is more difficult to treat in HIV-co-infected patients than in mono-infected
patients. Sustained virological response (undetectable HCV RNA 24 weeks post-treatment) rates for HCV/HIV-co-infected patients treated with 180 µg/week pegylated
interferon-α-2a (40 Kd) and 800 mg/day ribavirin for 48 weeks in the
APRICOT study were 29% and 62% for genotype G1 and G2/3, respectively. There is
therefore a need to identify patients with higher chances of sustained
virological response in this population. We evaluated the predictive values for
sustained virological response of both week 4 and week 12 on-treatment
virological responses in HCV/HIV-co-infected patients, a treatment optimization
strategy that has been successfully employed in mono-infected patients.
Methods: This retrospective
analysis included 271 patients with HCV G1 or G2/3 randomized to 180 µg/week
peg-interferon-α-2a (40 Kd) and 800 mg/day ribavirin for 48 weeks in the
APRICOT study. On-treatment responses were defined as rapid virological
response (undetectable [<50 IU/mL] HCV RNA at week 4), complete early
virological response (non-rapid virological response but undetectable HCV RNA at week 12) or partial early virological response (non-rapid virological response and non-complete
early virological response but ≥2 log reduction in HCV RNA from baseline). The prediction of sustained virological response based on week 4 and week 12
responses was assessed.
Results: Sustained virological
response rates were high in HCV/HIV-co-infected patients who achieved an rapid
virological response (G1, 81.8% [18 of 22]; G2/3, 94.3% [33 of 35]). The
categorization of week 12 responses into complete and partial early virological
response allowed patients who achieved high sustained virological response rates
(G1, 63.2% [24 of 38]; G2/3 69.7% [23 of 33] in patients with a complete early
virological response) to be distinguished from those with low sustained
virological response rates (G1, 17.4% [8 of 46]; G2/3 18.2% [2 of 11] in
patients with a partial early virological response).
Conclusions: The predictive value
of week 4 and week 12 responses for sustained virological response in co-infected
patients is similar to that in mono-infected patients. While rapid virological
response is the strongest predictor of sustained virological response, those co-infected
patients with a complete early virological response also achieve high sustained
virological response rates. Week 4 and 12 responses can be used to guide
treatment decisions in HCV/HIV-co-infected patients. Prospective studies are
needed to show whether these predictive values can be used for individualization
strategies, such as shorter or longer treatment duration.
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