Treatment of Condylomata acuminata with Pegylated Interferon Alfa-2b in HIV-infected Patients.

摘要

Background: Interferon in a variety of topical, interlesional, and parenteral preparations has been used for condylomata acuminata (CA) in HIV negative patients. - Study goals: This open trial was initiated to determine the safety and efficacy of a new formulation of interferon, pegylated interferon-alpha2b (PEG-IFN, PegIntron(R)), in the treatment of recalcitrant CA in patients with HIV infection. - Study design: 22 HIV-1 infected patients in virologic steady state with clinically demonstrable anogenital CA were enrolled in this study (treatment group, n = 12; control group, n = 10). Patients in the treatment group received 80mug PEG-IFN s.c. once a week for 24 weeks. Follow-up period was 6 month. The effects were assessed by a clinical scoring system (complete response; major response; minor response; stable disease; progression of disease). - Results: 2 patients did not finish the study because of side effects. PEG-IFN was well accepted and completed by ten patients. Four patients revealed complete response, four patients had major response and two had minor response after PEG-IFN. In the control group, all patients showed progression of CA during the 24 weeks of this study (p < 0.001). 7/10 patients of the treatment group and 8/10 patients of the control received HAART. - While the differences of CD4 cell counts between treatment group and control group were not significant (increase of the mean CD4 cell count in the treatment group was 31.5 (75.33 without patient 1 with leucopenia under ribavirine), in the control group 69.75 CD4 cells), the HIV RNA decline in the PEG-IFN group was impressive (0.74 log subset10). Biological side effects of PEG-IFN treatment included flu-like symptoms, fatigue, local reaction, leucopenia, and increase of AST. This result makes an educated guess that PEG-IFN enhances the benefit of HAART. - Conclusion: PEG-IFN is an effective and safe therapy option in HIV infected individuals with CA with concomitant positive effects on the suppression of HIV-1 replication and CD4 cellcount. It might be considered as an alternative in patients that have failed to standard therapies of CA and - at the same time -could improve the benefit of HAART to a great extent. This last hypothesis needs further research.