dc.contributor.author | Hampson, Lynne | |
dc.contributor.author | Maranga, Innocent O. | |
dc.contributor.author | Masinde, Millicent S. | |
dc.contributor.author | Oliver, Anthony W. | |
dc.contributor.author | Gavin, Batman | |
dc.contributor.author | Xiaotong, He | |
dc.contributor.author | Minaxi, Desai | |
dc.contributor.author | Okemwa, Parmenas M. | |
dc.contributor.author | Helen, Stringfellow | |
dc.contributor.author | Pierre, Martin-Hirsch | |
dc.contributor.author | Mwaniki, Alex M | |
dc.contributor.author | Gichangi, Peter | |
dc.contributor.author | Hampson, Ian N. | |
dc.date.accessioned | 2017-03-21T13:40:15Z | |
dc.date.available | 2017-03-21T13:40:15Z | |
dc.date.issued | 2016 | |
dc.identifier.citation | Hampson, Lynne, et al. "A Single-Arm, Proof-Of-Concept Trial of Lopimune (Lopinavir/Ritonavir) as a Treatment for HPV-Related Pre-Invasive Cervical Disease." PloS one 11.1 (2016): e0147917. | en_US |
dc.identifier.uri | http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0147917 | |
dc.identifier.uri | http://hdl.handle.net/11295/100668 | |
dc.description.abstract | Background
Cervical 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.
Methods
Between 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.
Results
A 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.
Conclusions
These 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. | en_US |
dc.language.iso | en | en_US |
dc.publisher | University of Nairobi | en_US |
dc.rights | Attribution-NonCommercial-NoDerivs 3.0 United States | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/us/ | * |
dc.title | A Single-Arm, Proof-Of-Concept Trial of Lopimune (Lopinavir/Ritonavir) as a Treatment for HPV-Related Pre-Invasive Cervical Disease | en_US |
dc.type | Article | en_US |