“Receiving appropriate advice regarding to the new HPV and cervical cancer prevention strategies is a woman’s right,” said Dr. Javier Cortés during the first Ginecare webinar, organized by Procare Health Iberia.
Almost two million women in Spain are carriers of the Human Papilloma Virus (HPV). Of these two million, 370,000 has low grade cervical lesions, compared to 73,000 of high grade cases. Each year between 2,500 and 3,000 cases of cervical cancer are diagnosed in our country, bringing the number of deaths from this type of tumour to 500. This data is provided by Dr. Javier Cortés, gynecologist in Palma and former president of the AEPCC (Spanish Society of Cervical Pathology and Colposcopy) and Eurogin, who last Friday, May 8th, gave the webinar “Medical treatment of cervical lesions by HPV and its presence: effectiveness of a gel based on Coriolus versicolor“, organized by Procare Health in the continuing medical training platform Ginecare.
Dr. Cortés explained the limitation of the treatments years ago, when a woman came to the doctor’s office. “In the past we had nothing, but today we will talk about what can be done to help to eliminate the Papilloma. Five hundred women die every year in Spain due to cervical cancer, and none of them would die if we do things right,” he said.
Javier Cortés explained that there are four factors that cause HPV to persist if it remains anchored in the cervix: the viral type, the histological structure of the exocervix, alterations in the vaginal microbiota and the patient’s immune status. As he explained, the viral type cannot be changed.However, the other three factors are modifiable and therefore strategies aimed at those factors would make it difficult for HPV or lesions to persist. In this sense, he presented the clinical development plan for Papilocare, a treatment from Procare Health, a pharmaceutical laboratory specialized in women’s health, to prevent and treat low-grade lesions of the cervix caused by HPV.
Clinical trials demonstrate the efficacy of Papilocare.
Papilocare was launched in 2016, as the first and only product on the market in Europe indicated for the prevention and treatment of low-grade cervical lesions caused by HPV. It is a Class IIa medical device in the form of a gel for vaginal application containing phytotherapeutic ingredients, including Coriolus versicolor.
Dr. Cortés presented, during the webinar, the results of the PALOMA clinical trial. It included 101 patients and ended in June 2019, achieving normalization of low grade cervical lesions in 85% of the patients treated with Papilocare at six months. This result was even more significant in women infected with high-risk HPV genootypes, which are the main responsible in cervical cancer, normalizing HPV lesions in 88% of patients compared to 56% in the control group.
The PALOMA clinical trial also showed a clarification of high-risk HPV in 63% of patients treated for six months vs. 40% of the control group, which means an increase of 57%.
Other studies and trials in progress
Dr. Cortés reviewed other studies and trials in progress, such as the PAPILOBS study, which aims to evaluate the efficacy of Papilocare vaginal gel in normalizing cytological alterations caused by HPV with concordant colposcopy, as well as in clearing HPV at 6 and 12 months in real life. This is a study in which 38 public and private centers throughout Spain are collaborating.
Preliminary data from the PAPILOBS study shows the consistent efficacy of Papilocare in normalizing cervical lesions at 6 (66%) and 12 months (91%) in the total population. Also the efficacy in HPV clearance at 6 (63%) and 12 months (82%) in the total population.
The PALOMA 2 trial is also currently underway, which plans to include 288 patients in eight public centers, and PAPILOCAN, a placebo-controlled clinical trial with the planned inclusion of 200 patients at the University Hospital Ntra. Sra. de Candelaria in Santa Cruz de Tenerife. These trials will evaluate cytological normalization with concordant colposcopy, cervical epithelialization, HPV clearance, vaginal health index, level of perceived stress, and tolerability, satisfaction and compliance with Papilocare treatment.
Independent observational studies have also been carried out in public university hospitals in different Spanish cities (Vigo, A Coruña, Hospitalet de Llobregat) and in a private center in Bari (Italy). The results of these studies are in line with those obtained in the PALOMA and PAPILOBS trials, since the percentage of HR-HPV clearance in all of them ranges between 50 and 70% at six months in a population of more than 700 patients.
Education and challenges we must assume
It is essential that all professionals involved in women’s health educate patients when they come to the clinic. “Educating the population on all that we know about HPV (detection, vaccination and redesigned screening) is an obligation for obstetricians and gynecologists,” said Dr. Cortés. He also insisted that “receiving appropriate advice regarding new HPV and cervical cancer prevention strategies is a woman’s right.
Worldwide, the World Health Organization (WHO) estimates that in 2018 there were 570,000 new cases, representing 7.5% of female cancer mortality. Of the approximately 311,000 deaths from cervical cancer each year, more than 85% occur in less developed regions. Tedros Adhanom, WHO General Director, committed during his campaign in 2016 to support the global erradication of cervical cancer. Adhanom says that innovative technologies and strategies are needed to achieve this, and that if we do not act, deaths from cervical cancer will increase by 50% in 2030.
The approach to prevent and controll cervical cancer should be comprehensive, multidisciplinary and must include education, vaccination, screening, treatment and palliative care, according to WHO. Regarding vaccination, Dr. Javier Cortés stated that treatment with Papilocare vaginal gel is complementary, and thus “Papilocare does not compete with vaccination”. The specialist mentioned that the HPV vaccination rate in Spain is 72%, and that it is included in the vaccination calendar for 14-year-old women, which is 100% subsidized by social security. This percentage, he said, guarantees group immunity. In the case of women not covered by public health programs, vaccine coverage barely reaches 1%, he said.
Regarding male vaccination, it is not currently performed in our country, but there are already countries, such as Australia, that have extended the HPV vaccine to children, being one of the first to take this measure. After a decade, it is about to become the first to eradicate cervical cancer thanks to its prevention policy that began in 1991.
Detection programs and screening tests
Dr. Cortés also made reference to detection programs, which are not currently a priority for health care in our country, recalling that 30% of unchecked women account for 85% of cervical cancers. “In the future we will have to sit down and redesign the cervical cancer detection and screening programs in our health system,” he said.
Javier Cortés told the health professionals who participated in the webinar that “we can be proactive and help women with preventive and innovative strategies like Papilocare, aligning ourselves with the objectives of the WHO. This is the only way we can ensure that our granddaughters do not suffer the threat of the cervix in the future,” he concluded.
Ginecare, Continuing Medical Education
At Procare Health we have always been committed to the strength of science and scientific studies as the basis of our products, sharing advances and discussions with health professionals through conferences and medical seminars. In spite of the situation of uncertainty we are living, we wanted to continue at the side of the health professional and bet on a complementary model to continue offering a continuous medical training of quality”, said Yann Gaslain, CEO of Procare Health during the presentation of the session, in which Dr. Anna Mallafré also participated as moderator.
This webinar has been the first of a cycle aimed to professionals specialized in women’s health (pharmacists, doctors, nurses and midwives) which will be held at Ginecare CME. Yann Gaslain explained that Ginecare CME is a platform that has been developed in collaboration with Grupo Saned and El Médico Interactivo. It is also endorsedby two leading medical societies in gynecology, Private Gynecologists (Ginep) and the Spanish Association for the Study of Menopause (AEEM), and of the scientific journal Toko- Ginecología Practica.
Ginecare CME will host a large amount of scientific content in webinar format, which will be produced every three weeks and will be freely accessible through the web. The next webinar will take place on the 2nd of June by Dr. Santiago Palacios, about Women’s Health in the peri and postmenopause, and will be directed to gynecologists.
In addition, and beyond the webinars, Ginecare CME will be a platform for continuing medical education, so it will also host publications, videos, news, courses, summary of international conferences and much more scientific content, said Yann Gaslain. “In this sense, we will soon have the pleasure of launching the second edition of the HPV training course that, like the first edition (available in Ginecare CME, with 2.7 credits), will be accredited by the Spanish continuing education commission”, added Gaslain. “Ginecare will be, therefore, a tool that allows us to have an integral approach in the medical-scientific formation that includes all the sanitary professionals in charge of the women’s health”, concluded.