842 Predictive Value of Early Virological Response (12 Weeks) to Pegylated Interferon plus Ribavirin in HIV-HCV Co-infected Patients MAYTE PEREZ-OLMEDA*, LUZ MARTÍN-CARBONERO, PILAR RIOS RISQUEZ, MARINA NUÑEZ , JUAN GONZÁLEZ-LAHOZ, VICENTE SORIANO VAZQUEZ Hosp Carlos III, Madrid, Spain
Background: HCV-related liver disease is a growing cause of morbidity/mortality among HIV co-infected patients (pts). Treatment of chronic hepatitis C offers now cure to 60% of HIV- pts. Response rates seem to be lower in HIV+ pts, but side effects may be more frequent, as result of the interaction between RBV and nucleoside analogs. Therefore, the recognition of early predictors of lack of treatment response may allow discontinuing anti-HCV therapy when no benefit is expected to be obtained. Recent guidelines have pointed out that reductions in HCV-RNA > 2 logs at 12 wks of anti-HCV therapy have a negative predictive value (NPV) of 97%. No data are available on the validity of this rule in HIV co-infected pts. Moreover, preliminary reports have claimed that HCV-RNA clearance under treatment may be slower in HIV+s.
Methods: We analyzed 89 HIV-HCV co-infected pts who completed a course of anti-HCV combination therapy. Pegylated interferon (IFN) was administered to 63 and regular IFN to the remaining 26 pts, always using standard doses. All received a fixed dose of RBV (400 mg bid). HCV genotypes were distributed as follows: 1-4 (62%) and 2-3 (38%). Treatment was provided for 6 months (mos) in genotypes 2-3 and for 12 mos in genotypes 1-4. Overall, sustained virological response (SVR) occurred in 29 pts. End-of-treatment response with further relapse was seen in 15. The remaining 45 were non-responders.
Results: A drop in HCV-RNA > 2 logs was seen in 38 (43%) and 52 (58%) of pts at 4 and 12 wks, respectively. Of those subjects, only 18 (48%) and 29 (56%), respectively, reached SVR. In contrast, SVR occurred in 11 (38%) and 0 pts who did not show a > 2 log drop in HCV-RNA at wks 4 and 12, respectively. Thus, the NPV was 100% at wk 12. There were no significant differences between HCV genotypes, baseline HCV-RNA, and use of either pegylated or regular IFN. In pts with HCV 2-3, a high rate of relapse in early responders was noticed, suggesting that extending treatment beyond 6 mos might have provided a higher SVR rate in them.
Conclusions: The use of an early time-decision point at 12 wks to identify which subjects will not benefit from continuing anti-HCV treatment is valid for HIV+ pts. However, a delayed clearance of HCV-RNA in early responders with HIV might account for a higher relapse rate when treatment is stopped prematurely (e.g., 6 mos in genotypes 2-3).