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Treatment of Condylomata Acuminata with Pegylated Interferon Alfa-2B In

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Treatment of Condylomata Acuminata with Pegylated Interferon Alfa-2B In January 31, 2006 EUROPEAN JOURNAL OF MEDICAL RESEARCH 27 Eur J Med Res (2006) 11: 27-32 © I. Holzapfel Publishers 2006 TREATMENT OF CONDYLOMATA ACUMINATA WITH PEGYLATED INTERFERON ALFA-2BINHIV-INFECTED PATIENTS* N. H. Brockmeyer1, A. Poffhoff1, A. Bader1, B. Hochdorfer1, R. Schlottmann1, H. Rasokat2, P. Altmeyer1, A. Kreuter1, for the German Network of Competence HIV/AIDS 1Department of Dermatology, Ruhr-University, Bochum, 2Department of Dermatology, University of Köln, Germany Abstract as an alternative in patients that have failed to standard Background: Interferon in a variety of topical, interle- therapies of CA and – at the same time –could im- sional, and parenteral preparations has been used for prove the benefit of HAART to a great extent. This condylomata acuminata (CA) in HIV negative patients. last hypothesis needs further research. Study goals: This open trial was initiated to determine the safety and efficacy of a new formulation of inter- INTRODUCTION feron, pegylated interferon-α2b (PEG-IFN, Peg- Intron®), in the treatment of recalcitrant CA in pa- Condylomata acuminata (CA) is a genital infection tients with HIV infection. caused by human papillomavirus (HPV). It is one of Study design: 22 HIV-1 infected patients in virologic the most common sexually transmitted diseases that is steady state with clinically demonstrable anogenital increasing in prevalence. A variety of HPV subtypes, CA were enrolled in this study (treatment group, n = mostly HPV 6 and 11, have been identified in genital 12; control group, n = 10). Patients in the treatment lesions [1]. Usually they produce benign lesions, but a group received 80µg PEG-IFN s.c. once a week for 24 few oncogenic subtypes such as HPV 16 and HPV 18 weeks. Follow-up period was 6 month. The effects are associated with anogenital cancer [2]. The standard were assessed by a clinical scoring system (complete treatment modalities for CA include cryotherapy, elec- response; major response; minor response; stable dis- trosurgery, laser therapy, and application of podophyl- ease; progression of disease). lotoxin or trichloracetic acid. Recently, imiquimod as Results: 2 patients did not finish the study because of the first immune response modifier to stimulate a lo- side effects. PEG-IFN was well accepted and complet- calized immune response in CA has been added to the ed by ten patients. Four patients revealed complete re- therapeutical armamentarium. Recurrence of CA due sponse, four patients had major response and two had to the presence of HPV DNA in the clinically asymp- minor response after PEG-IFN. In the control group, tomatic surrounding tissue is a major problem of abla- all patients showed progression of CA during the 24 tive therapy. These recurrence rates reported in the lit- weeks of this study (p < 0.001). 7/10 patients of the erature range from 7.5% to 80% [3]. treatment group and 8/10 patients of the control re- Human immunodeficiency virus (HIV) progressive- ceived HAART. ly destroys regulatory and effector cells of the (cuta- While the differences of CD4 cell counts between neous) immune system, leaving patients highly vulner- treatment group and control group were not signifi- able to bacterial, fungal, and viral infections, especially cant (increase of the mean CD4 cell count in the treat- HPV [4]. Recombinant interferons (IFN) have been ment group was 31.5 [75.33 without patient 1 with leu- shown to be active agents in various viral infections. In copenia under ribavirine], in the control group 69.75 several studies the efficacy of interferons in a variety CD4 cells), the HIV RNA decline in the PEG-IFN of topical, interlesional, and parenteral preparations group was impressive (0.74 log10). Biological side ef- has been reported for CA in HIV negative patients fects of PEG-IFN treatment included flu-like symp- [5, 6]. toms, fatigue, local reaction, leucopenia, and increase We initiated this trial to determine the safety and ef- of AST. This result makes an educated guess that ficacy of a new formulation of interferon, pegylated PEG-IFN enhances the benefit of HAART. interferon-α2b (PEG-IFN, PegIntron®), in the treat- Conclusion: PEG-IFN is an effective and safe therapy ment of recalcitrant CA in patients with HIV infec- option in HIV infected individuals with CA with con- tion. comitant positive effects on the suppression of HIV-1 replication and CD4 cell count. It might be considered MATERIAL AND METHODS PATIENTS *Funding sources: Federal Ministry of Education and Re- search, German Network of Competence HIV/AIDS, Grant 22 patients with documented laboratory diagnosis of No. 01 KI 0211. HIV infection (two arms: treatment group (the PEG- 28 EUROPEAN JOURNAL OF MEDICAL RESEARCH January 31, 2006 IFN-Group) and control group (no treatment for CA) formed at week 24 and after the six-month follow-up. in virologic steady state with clinically demonstrable We monitored local and systemic side effects at every anogenital CA were enrolled in the two following cen- visit during the treatment period and during follow-up tres: the Department of Dermatology, Ruhr-Universi- period. We inquired the patients treated with PEG- ty, Bochum; and the Department of Dermatology, IFN about the presence of fatigue, depressions, local University of Köln. One woman and eleven men reactions, and flu-like symptoms including fever chills, (mean age 38.2 years, range 24 to 58 years) were in- myalgia, malaise and headaches during therapy. The cluded in the treatment group (Table 1); one woman severity of adverse events was determined according and 9 men (mean age 41.3 years, range 30 to 62 years) to the National Cancer Institute (NCI) Toxicity Crite- were included in the control group (Table 2). Patient’s ria. We collected complete blood counts, serum stage of HIV infection was classified according to the chemistries, HIV RNA testing and lymphocyte sub- WHO/CDC criteria. In the treatment group, seven population determination at entry and every month patients received highly active antiretroviral therapy during the 24 weeks of therapy. Patients were not al- (HAART), three patients were naive to HAART. The lowed to use any kind of non-steroidal anti-inflamma- diagnosis CA was established according to clinical and tory drug during treatment period except paracetamol, histopathological criteria, in this group mean duration which was allowed to prevent flu-like symptoms after of CA was 43.1 months (range 1 to 92 months). No each PEG-IFN administration. Local discomfort and other treatment (e.g. podophyllotoxin, topical or sys- erythema at the injection site was relieved using topical temic viral therapy) had been given for at least four corticosteroids and cold compresses. Patients were weeks before initiation of therapy. In the control dropped out of the study in case of grossly abnormal group, eight patients received HAART, two patients blood counts or if they missed more than two consec- were naive to HAART. Mean duration of CA in this utive visits. group was 37.1 months (range 12 to 96 months). No treatment of CA (podophyllotoxin, topical and sys- EVALUATION OF EFFICACY temic viral therapy) was performed in the control group. Response to treatment was evaluated using the follow- Woman of childbearing age had to have a negative ing criteria: pregnancy test at entry. All patients were advised to Complete response (CR): 100% clearance of CA use condoms during the study to minimalize the risk Major response (MR): at least 50% and less than 100% of reinfection. Pregnancy, autoimmune disorders, psy- reduction of CA chiatric conditions, a history of cardiac, pulmonary, Minor response (mR): at least 25% and less than 50% hepatic, or central nervous system disorders were ex- reduction of CA clusion criteria’s. A history of an active opportunistic Stable disease (SD): less than 25% reduction but less infection within the last twelve month before study than 50% increase of CA entry was an exclusion criteria. We also excluded pa- Progression of disease (PD): more than 25% increase of tients, who had a serum creatinine one and a half CA times the upper limit of normal, a white blood cell count less than 3000 cells/mm3, a platelet count below STATISTICAL ANALYSIS 100000 elements/mm3, or an aspartate aminotrans- ferase serum concentration greater than twice the up- For distribution we used the Kolmogorov-Smirnov per limit of normal. test; for comparison of paired samples by normal dis- tribution we used the 2-tailed paired students t-test STUDY DESIGN and Pearson's correlation (r); for comparison of paired samples by non-normal distribution: the Wilcoxon- All patients had to give informed consent for partici- test. If data were given on a nominal scale we used the pation. All of them had a history of previous treat- McNemar Chi-Quadrat test. For comparison of two ments for CA. Before initiation of therapy, genitoanal independent samples by normal distribution we ap- region was clinically inspected. Additionally, all pa- plied the t-test for independent samples; for compari- tients underwent anoscopic examination for CA. son of two independent samples by non-normal distri- These examinations were repeated monthly until a fol- bution, we used the Mann-Whitney U test (two-tailed). low-up period of six month. At study entry, all visible Data are given as mean and standard deviation (SD). warts greater than 5 mm in diameter were electrosurgi- P values are two sided and are considered to be sig- cally removed in both PEG-IFN and control group. nificant when p < 0.05, very significant when p < 0.01 Smaller warts were not treated to document the effects and highly significant when p < 0.001. of PEG-IFN. Patients in our treatment group received 80 microgram PEG-IFN (PegIntron®) once a week RESULTS for 24 weeks. Each injection was given subcutaneously.
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