Abstract
BackgroundCervical cancer is the most common female malignancy in the developing nations and the third most common cancer in women globally. An effective, inexpensive and self-applied topical treatment would be an ideal solution for treatment of screen-detected, pre-invasive cervical disease in low resource settings.MethodsBetween 01/03/2013 and 01/08/2013, women attending Kenyatta National Hospital's Family Planning and Gynaecology Outpatients clinics were tested for HIV, HPV (Cervista®) and liquid based cervical cytology (LBC -ThinPrep®). HIV negative women diagnosed as high-risk HPV positive with high grade squamous intraepithelial lesions (HSIL) were examined by colposcopy and given a 2 week course of 1 capsule of Lopimune (CIPLA) twice daily, to be self-applied as a vaginal pessary. Colposcopy, HPV testing and LBC were repeated at 4 and 12 weeks post-start of treatment with a final punch biopsy at 3 months for histology. Primary outcome measures were acceptability of treatment with efficacy as a secondary consideration.ResultsA total of 23 women with HSIL were treated with Lopimune during which time no adverse reactions were reported. A maximum concentration of 10 ng/ml of lopinavir was detected in patient plasma 1 week after starting treatment. HPV was no longer detected in 12/23 (52.2%, 95%CI: 30.6–73.2%). Post-treatment cytology at 12 weeks on women with HSIL, showed 14/22 (63.6%, 95%CI: 40.6–82.8%) had no dysplasia and 4/22 (18.2%, 95%CI: 9.9–65.1%) were now low grade demonstrating a combined positive response in 81.8% of women of which 77.8% was confirmed by histology. These data are supported by colposcopic images, which show regression of cervical lesions.ConclusionsThese results demonstrate the potential of Lopimune as a self-applied therapy for HPV infection and related cervical lesions. Since there were no serious adverse events or detectable post-treatment morbidity, this study indicates that further trials are clearly justified to define optimal regimes and the overall benefit of this therapy.Trial RegistrationISRCTN Registry 48776874
Highlights
Infection with high-risk types of Human papilloma virus (HPV) has been established as the main aetiological agent for invasive cervical cancer (ICC)[1,2,3] and globally there are >270,000 deaths from this disease per annum with over 85% of these occurring in low resource countries[4]
Post-treatment cytology at 12 weeks on women with high-grade squamous intraepithelial lesions (HSIL), showed 14/22 (63.6%, 95%CI: 40.6–82.8%) had no dysplasia and 4/22 (18.2%, 95%CI: 9.9–65.1%) were low grade demonstrating a combined positive response in 81.8% of women of which 77.8% was confirmed by histology. These data are supported by colposcopic images, which show regression of cervical lesions. These results demonstrate the potential of Lopimune as a self-applied therapy for HPV infection and related cervical lesions
Infection with high-risk types of HPV has been established as the main aetiological agent for invasive cervical cancer (ICC)[1,2,3] and globally there are >270,000 deaths from this disease per annum with over 85% of these occurring in low resource countries[4]
Summary
Infection with high-risk types of HPV has been established as the main aetiological agent for invasive cervical cancer (ICC)[1,2,3] and globally there are >270,000 deaths from this disease per annum with over 85% of these occurring in low resource countries[4]. The development of ICC can take 10–20 years and is preceded by HPV related pre-invasive pathology which are characterised as either low-grade (CIN1) or high-grade cervical intraepithelial neoplasia (CIN2/3)[1]. These lesions can be screen detected by cervical cytology testing where they are diagnosed as either borderline atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesions (LSIL) or high-grade squamous intraepithelial lesions (HSIL)[6]. The reduction in ICC related mortality in the developed world has been largely dependent on organised cytology screening and similar trends in cervical cancer mortality have been achieved by organised single screen and treatment in low resource settings [7]. Inexpensive and self-applied topical treatment would be an ideal solution for treatment of screen-detected, pre-invasive cervical disease in low resource settings
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