Abstract
Objectives: Interferon alpha-2b possesses variable activity against human papillomavirus (HPV) associated cervical intraepithelial neoplasia (CIN). No topical therapy is currently available for treatment of early stage CIN. We evaluated a new patented drug delivery technology in order to achieve topical efficacy. Methods: Two separate studies were conducted in parallel. IFN002 (treatment group) was an open label study. Twenty patients with Pap IIW, III and IIID (CIN1) were treated with intravaginal application of Interferon alpha-2b cream (5 g, 2 MIU/g) three times a week (alternate days) for 6 weeks with 6 weeks of follow up to determine its effect on cytologic and colposcopic assessment. HPV001 (control group) was a 12 week observational study. Both studies had similar inclusion/exclusion criteria and patient population. Results: In IFN002, 8 of 20 patients (40%) in the ITT population showed resolution of abnormal Pap smear during the 12 weeks following start of treatment (responders). In HPV001, 7 of 21 patients (33.3%) were regressors (p = 0.45, one-sided FET). In the PP population, 7 of 12 (58.3%) patients in IFN002 were regressors com-pared to 7 regressors of 19 patients (36.8%) in HPV001 patients (p = 0.21, one-sided FET). Among patients with Pap IIID, 8 of 14 patients in IFN002 showed resolution of abnormal Pap smear, while 4 of 14 patients resolved in HPV001 (one-sided FET, p = 0.13). Conclusions: Interferon alpha-2b cream (5 g, 2 MIU/g) may be an effective treatment for CIN 1 patients, and future investigation is warranted.
Highlights
Human papillomavirus (HPV) infection is one of the most commonly acquired sexually transmitted infections (STI)
In the Per Protocol (PP) population, 7 of 12 (58.3%) patients in IFN002 were regressors compared to 7 regressors of 19 patients (36.8%) in HPV001 patients (p = 0.21, one-sided Fisher’s Exact Test (FET))
Among patients with Pap IIID, 8 of 14 patients in IFN002 showed resolution of abnormal Pap smear, while 4 of 14 patients resolved in HPV001
Summary
Human papillomavirus (HPV) infection is one of the most commonly acquired sexually transmitted infections (STI). More than 6 million people acquire HPV infections annually [1]. It is well known that infection with one or more of several oncogenic subtypes of HPV can lead to development of cervical intraepithelial neoplasia (CIN). In the US, an estimated 1.5 million women present annually with low-grade squamous intraepithelial lesions (LSIL) [2], which is roughly equivalent to CIN 1 [3]. These LSIL/ CIN1 lesions may regress without treatment, they could progress to invasive vaginal, vulvar, and anal cancer, especially in women with persistent presence of high-risk HPV types
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