THE CASE OF SCHISTOSOMIASIS AND NCDS UNESCOMARS Session

THE CASE OF SCHISTOSOMIASIS AND NCD‘S UNESCO-MARS Session: Identifying the scientific research priorities for evolving health needs: the case of infectious diseases and women health Addis Ababa, Nov. 28 th Jutta Reinhard-Rupp Head of Global Health R&D, Merck

Setting the Scene 1 Schistosomiasis in Women § 2 3 NCDs impacted by Schistosomiasis § Fertility § Cancer Research Needs § 1 Female Genital Schistosomiasis Merck Global Health

Schistosomiasis – some Key Facts 258 Mio. One of the People in need of treatment worldwide 20, 000 -200, 000 deaths annually Most prevalent parasitic diseases in Africa Most important in terms of public health burden & economic impact Chronic disease Risk caused by a parasitic worm (S. mansoni, S. haematobium, S. japonicum) Effects anemia, stunted growth, impaired learning ability & chronic inflammation of the organs 22 Theodor M. Bilharz (S. haematobium) 1851, Cairo of infection due to exposure to infected water (children, women, fishermen) Preventive Chemotherapy (PCT) with praziquantel To prevent from developing severe late-stage disease (>100 Mio people treated since 2007)

Female Genital Schistosomiasis (FGS) “A case of bilharzia of the vagina” was published in the Lancet in 1899 by F. C. Madden 33

Female Genital Schistosomiasis (FGS) A call for action against a neglected gynaecological disease (IJP; 2016 V. Christinet et al. ) • highly prevalent disease manifestation (> 20 -150 Mio girls & women infected) • one of the most common gynecological conditions in sub-Saharan Africa FGS results in : o o o o o 4 Adnexal masses Uterine body associated pathology Vulvo-vaginal pathology Cervical alterations Ectopic pregnancies Cervical schistosomiasis and HIV Cervical schistosomiasis, HPV and cervical carcinoma Subfertility & Infertility (Sub-Saharan Subfertility belt) Mental harm & Stigmatization Ref. : WHO – FGS Pocket Atlas - http: //apps. who. int/iris/bitstream/10665/180863/1/9789241509299_eng. pdf

Setting the Scene 1 Schistosomiasis in Women § 2 3 NCDs impacted by Schistosomiasis § Fertility § Cancer Research Needs § 5 Female Genital Schistosomiasis Merck Global Health

Infertility and Sub-Fertility World-wide infertility prevalence: 8 -12% Sub-Saharan Africa “Infertility Belt”: 30% + § Case-control studies have shown a significant association between S. haematobium and infertility (Zimbabwe, Malawi) § Tubal schistosomiasis was found in 40% of cases with primary & secondary infertility (Zanzibar) § Urinary schistosomiasis was found in 38. 5% of cases with infertility (Niger) What would we find out with more awareness, better training and diagnosis? 6

HPV and Cervical Cancer …. and Cervical Schistosomiasis (FGS) Plausible link between FGS and HPV infection & Cervical Cancer Chronic disease which can be acquired during childhood, damages the cervical epithelium Local immune environment becomes favorable for viral infections FGS characterized by sandy patches, erosion, mucosal bleeding, abnormal blood vessels HPV vaccination and effective health interventions (Broutet et al. , 2013) => 14 health-related interventions that are affordable: screening (for schistosomiasis and defects in vision) health education (on mosquito-borne diseases, the benefits of exercise, accessing health care, and sexual and reproductive health) skills building (improving condom usage) delivery of commodities (anthelminthic drugs), vitamin A supplements, soap and/or bed nets Cervical Cancer – Cervical Schistosomiasis Risk of misdiagnosis due to cervical schistosomiasis 7

Setting the Scene 1 Schistosomiasis in Women § 2 3 NCDs impacted by Schistosomiasis § Fertility § Cancer Research Needs § 8 Female Genital Schistosomiasis Merck Global Health

Research needs– FGS should NOT remain the forgotten gynaecological disease NEED FOR. . . Awareness & Advocacy - Directors of Health Services, incl. Public Health and Family Health - Institutional Care divisions - Health staff (clinicians, public health officers, obstetricians, gynaecology consultants, nurses, CHWs) Training - Inclusion of FGS in training sessions at all levels; FGS pocket atlas Research - Disease Research (epidemiology, diagnosis, treatment of younger children) - Social Science Research (how women understand FGS symptoms, who they consult, community messaging, engagement strategies, traditional health networks) Collaboration - Intensify multi-sectoral collaboration with Ministries of Health/ Water/ Works/ Housing/ Education 9

Global Health R&D at Merck Our Vision “No more children without a health solution” One Merck for Children Mission: Synergizing Merck business competencies to deliver sustainability and impact in health Focus on children Healthcare Life Science solutions addressing major Global Health challenges in most vulnerable populations Performance Materials Integrated Merck Drugs 10 10 Diagnostic Devices Medical Devices Digital Services

Global Health R&D at Merck Our Objectives Integrated health solutions addressing major Global Health challenges Deliver comprehensive Health Solutions Focus on Malaria and Schistosomiasis Concentrate on Children & Women Health 11 11 Foster strong external partnerships

Global Health R&D at Merck “One Merck for Schisto” : Integrated approach to tackle one of the most neglected tropical diseases Treatment Detection Merck Life Science & Healthcare • Diagnostics, e. g. Muse Schisto Kit Transmission Merck Innovation Cup • Vector control 12 12 Synergies within Merck delivering unique benefits to patients Merck Healthcare • Pediatric PZQ Consortium • Drug discovery • Disease Management (FGS) • Co-infections Control Program Merck • PZQ Donation Program • Anti-counterfeiting e. g. The GPHF-Minilab™ • e. Health & Education

http: //biopharma. merckgroup. com/infectiousdiseases http: //www. pediatricpraziquantelconsortium. org 13

Lessons learned from literature review Target organs for FGS • All female genital organs can be involved: the vulva, the vagina, the cervix, the uterus, the Fallopian tubes and ovaries. • From post-mortem studies it appears that the most frequently affected female reproductive organs are the cervix and the uterus body, then followed by the adnexa and the vulvo-vagina. • The clinical presentation of FGS is nonspecific, therefore, diagnosis requires histopathological visualization of the eggs in the lesions. • The lesions are the result of a granulamatous reaction to live or dead eggs. • S. haematobium eggs can be found in the lesions while they can be absent in the urine (by current detection methods). 1414