Topical hexaminolevulinate photodynamic therapy for the treatment of persistent human papilloma virus infections and cervical intraepithelial neoplasia

Abstract

Introduction: Current treatments for high-grade cervical intraepithelial neoplasia (CIN2/3) are mainly excisional procedures, which are associated with significant side effects and pose risks for future pregnancies. An effective and safe therapy is needed to reduce the requirement for surgical interventions in women of reproductive age.

Areas covered: This review looks at the pharmacokinetic and clinical data for topical hexaminolevulinate (HAL) photodynamic therapy (PDT), which is currently entering late phase clinical trials for high-grade CIN. The authors include published studies in patients and volunteers but laboratory and animal studies have been excluded as have studies on other porphyrins such as Photofrin, 5-aminolevulinic acid, methyl aminolevulinate and studies reporting other clinical applications for HAL.

Expert opinion: Topical HAL PDT has potential as a non-surgical tissue-preserving treatment for CIN and persistent oncogenic human papilloma virus infections. HAL PDT selectively treats the entire epithelial sheet, without the tissue destruction seen in excisional procedures. The authors believe that this treatment could replace surgery in a large proportion of patients. It would be of particular value to the high percentage of women who are interested in future child-bearing. If the treatment is approved, it is very likely that physicians will want to use this treatment, as many patients will be keen to consider a non-surgical option.

Keywords:

• cervical cancer
• cervical intraepithelial neoplasia
• hexaminolevulinate
• human papilloma virus
• photodynamic therapy

Declaration of interest

Studies with HAL PDT have been funded by Photocure, Oslo, Norway. P Hillemanns has received honoraria and research support from Photocure, while MH Einstein has advised/participated in educational speaking activities for Photocure but has not received any honorarium from any company. Montefiore Medical Center has received payment for his time spent for these activities from Photocure. Finally, OE Iversen has received lecture fees and payment as an investigator from Photocure. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing assistance by J Douglass of Healthcom Partners Ltd was utilized in the production of this manuscript and was funded by Photocure ASA.

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