Quality of medical services and their impact on the cascade of cares in HIV infection, at national level Roundtable discussion

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Quality of medical services and their impact on the cascade of cares in HIV infection, at national level Roundtable discussion Mariana Mărdărescu MD PhD Adrian Streinu-Cercel MD PhD HC Mike Youle MD PhD

I. ECDC S DEFINITION OF CASCADE OF CARE

Continuum of care: definitions The continuum of care is a conceptual framework that enables countries to monitor the effectiveness of key areas of HIV response. The sequential nature of the stages in the continuum can clearly indicate where countries need to focus their efforts and which programmes and activities require improvement. The continuum of HIV care is also a useful framework for assessing progress against the UNAIDS 90-90-90 targets for 2020: 90% of all PLHIV know their status; 90% of those diagnosed are receiving ART; 90% of all those on ART are virally suppressed. Source: Continuum of care. Monitoring implementation of the Dublin Declaration on Partnership to fight HIV/AIDS in Europe and Central Asia. 2017 Progress Report., p.1

Source: Continuum of care. Monitoring implementation of the Dublin Declaration on Partnership to fight HIV/AIDS in Europe and Central Asia. 2017 Progress Report., p.1

Source: Continuum of care. Monitoring implementation of the Dublin Declaration on Partnership to fight HIV/AIDS in Europe and Central Asia. 2017 Progress Report., p.3

II. UNAIDS/WHO GLOBAL INDICATORS

Global indicators for the monitoring and evaluation of the health sector response to HIV Source: Consolidated strategic information guidelines for HIV in the health sector. P32 http://apps.who.int/iris/bitstream/10665/164716/1/9789241508759_eng.pdf?ua=1&ua=1

Cascade of services and care Prevention of mother to child transmission Source: Consolidated strategic information guidelines for HIV in the health sector. P155 http://apps.who.int/iris/bitstream/10665/164716/1/9789241508759_eng.pdf?ua=1&ua=1

III. Cascade of care UK

Cascade of care UK 2015 Source: The future of HIV services in England Shaping the response to changing needs

IV. ROMANIA

HIV Cascade of care dinamics 80s: Clinical diagnosis Lab diagnosis Supportive therapy No antiviral therapy 90s: Clinical diagnosis Lab diagnosis Supportive therapy ARVT HAART

HIV Cascade of care dynamic s HIV Care based on lab tests 00s fist decade: Clinical diagnosis Lab diagnosis development Universal access to ARV therapy (Romania 2001) HIV mutations HIV sequencing New lab tests Define resistance profile: Genotypic Phenotypic Define HIV tropism: R5 Dual/mixt X4

HIV Cascade of care dynamic s Psychologic support Psychologic support via Psy cabinets Daily care units Outpatient care Social support Social workers been attached to the local care system Financial support Transportation support to regional centers

Cascade of care Romania 31 December 2016 from the cases registered in the National HIV/AIDS Data Base 1985-2016 16000 14000 12000 10000 8000 6000 4000 2000 0 16000 ESTIMATED PLWHA (UNAIDS 2017)* 14349 (80%) 12196 (85%) NUMBER OF PLWHA (registered in the National HIV/AIDS Data Base) PATIENTS IN ACTIVE SURVEILLANCE (registered in the national HIV/AIDS Data Base)** 10994 (90%) 6811 (62%) PATIENTS WITH ARV TREATMENT (registered in the Technical Assitance Unit for Management of the HIV/AIDS Programme) VL <50 copies/ml (in patients under ART) *Estimated number of PLWHA UNAIDS May 2017: low 14.000-high 18.000. ** Patients that access, at least two times per year, the HIV Regional Centres and have, at least, two viral load assessments Source: Compartment for Monitoring and Evaluation of HIV/AIDS Infection in Romania INBI Prof.Dr.M.Balş

Romania- 31 December 2016 (1985-2016) Stage Number Number/% out of all PLHIV Year Primary data source (cohort/surveillance/ot her specified) 1) PLHIV 14349 16.000 (14.000-18.000)* 2016 National HIV/AIDS Data Base 1985-2016 2) Diagnosed 22095 14349 2016 National HIV/AIDS Data Base 1985-2016 * Estimated number of PLWHA UNAIDS May 2017: 16.000 (low 14.000- high 18.000) The information registered in the National HIV/AIDS Database (name, personal identification number) UNAIDS estimates Romania s particular HIV/AIDS epidemic in non-vertically infected children in the early 1990s (approximately 10.000 registered). Different data registration systems, based on different definitions (e.g. Patients in active surveillance in ART V.L. <50 copies/ml) Source: M. Mardarescu. Romania- Cascade of Care 2016 Improving Monitoring of the HIV Continuum of Care Stockholm. 20-21st June 2017.

Romania (1985-2016) Stage Number Number/% out of all PLHIV 3) On ART 10994/12196 14349* (76%) 12196** (90%) 4) Virallysuppressed V.L. <50 copies/ml Year Primary data source (cohort/surveillance/ot her specified) 2016 Technical Assistance Unit for Management of the HIV/AIDS Programme 6811/10994 6811/10994 (62%) 2016 National HIV/AIDS Data Base 1985-2016 *The number of PLWHA in the National HIV/AIDS Database ** People in active surveillance: patients that access, at least two times per year, the HIV Regional Centres and have, at least, two viral load assessments How can we adapt our estimates system to ECDC s model? Source: M. Mardarescu. Romania- Cascade of Care 2016 Improving Monitoring of the HIV Continuum of Care Stockholm. 20-21st June 2017.

Summary of recommendations for monitoring a four-stage HIV continuum of care in Europe in a given year (YYYY) Stage Definition Numerator Denominator Notes 1) PLHIV Total number of PLHIV in the country by the end of year YYYY Estimated number PLHIV, diagnosed and undiagnosed, including in-migrations and excluding out-migrations/ deaths by end of year YYYY. N/A Back-calculation modelling using surveillance data e.g. HIV Modelling Tool. 2) Diagnosed Number/ proportion diagnosed with HIV Number ever diagnosed with HIV by end of year YYYY, including in-migrations and excluding out-migrations/ deaths by end of year YYYY. Total number of PLHIV (as defined for stage 1) Ideally not restricted to those in care. 3) On ART Number/ proportion who are taking ART in the year YYYY Number with 1 record of ART (prescribed or, ideally, dispensed) in year YYYY, regardless of treatment eligibility criteria. In-migrations are included and out-migrations/deaths by end of year YYYY are excluded. Any ART regimen since diagnosis, regardless of the number of ARV drugs. 1) Number diagnosed with HIV (as defined for stage 2), regardless of treatment eligibility criteria 2) Total number of PLHIV (as defined for stage 1) Denominator 1, the number diagnosed, should exclude deaths/ out-migrations by end of year YYYY. Ideally same data source as stage 2. 4) Virallysuppressed Number/ proportion virallysuppressed with <200 copies/ml Number on ART whose most recent HIV RNA measurement in year YYYY was <200 copies/ml, or below the level of detection of the assay. In-migrations are included and outmigrations/ deaths by end of year YYYY are excluded. 1) Number on ART (as defined for stage 3) 2) Total number of PLHIV (as defined for stage 1) Ideally same data source as stages 2 and 3. Source: M. Mardarescu. Romania- Cascade of Care 2016 Improving Monitoring of the HIV Continuum of Care Stockholm. 20-21st June 2017.

V. QUALITY OF MEDICAL SERVICES AND THEIR IMPACT ON THE CASCADE OF CARES IN HIV INFECTION, AT NATIONAL LEVEL

International requests... 2. No. of ever diagnosed who are in care or not been linked to care 1. Total estimated no. of PLWH, diagnosed &undiagnosed Romania 3. All who ever initiated ART Regardless of treatment regimen or interruption 4. Number of PLWH ever diagnosed, ever ART with V.L. < 200 copies at last visit

Challenges in Romania Surveillance National Treatment and Prevention Programme HIV Testing/ Screening Labs Clinician+ Laboratory (theoretically in real time) National HIV Data Base TB Network? HIV network Technical unit for management of the treatment Programme Surveillance of pregnant women and detection of the HIV+ women HIV Registry Pregnant women+exposed children

Adapting the Romanian HIV programme to the HIV epidemic HIV Programme financing: State budget HIV epidemic Particularities Romanian health care system+ Education HIV cascade of care + access to all services Universal access to specific cares

HIV Guidelines and the cascade of care in a Central-Eastern European country EACS Guidelines Oct. 2017 Romanian HIV Guidelines Romania WHO Guidelines 2016 Penta Guidelinies 2016

VI. Current status of HIV epidemic in Romania

CURRENT SITUATION Romania 2017 PLWHA MTCT ART IDUs Young by age, old by treatment Therapeutic fatigue New HIV infection cases: young people in their fertile age, late presentations in the sanitary system. MSM: increase of the number in dynamics Increase in HIV cases in adults. Young mothers, with multiple therapeutic schemes Mothers with unknown HIV status- recommendation for HIV testing and specific ART treatment New approach of HIV peinatalally exposed new bourns management. National Registry of HIV perinatally exposed children and of women infected with HIV. Most ARTs- available in Romania Universal access to treatment. Treatment introduction regardless of CD4 count. Treatment as prevention. Sub-optimal regimen during the first weeks of life Management of ART toxicity ART approach in young women living with HIV/AIDS New psychoactive substances. New approach of mothers who uses drugs and of new- bourns, perinatally exposed to HIV. Source : A. Streinu-Cercel. cnlas.ro: Specific Challenges of the HIV Epidemic in Romania. EACS 2013. M. Mardarescu. Et All. Risk factors involved in late detection of HIV mother to child transmission - data from the National Registry of HIV pregnant women and perinatally exposed children in Romania. 2 nd Vilnius Summit on Communicable Diseases. Oct 4-7, 2017. 14 th Congress of the BADV, October 5-7, 2017. Vilnius, Lithuania.

CURRENT SITUATION Romania 2017 FDC Tx Fatigue Comorbidities Aging Many FDC based on cobicistat Long term therapy + many therapeutic schemes + many VF + immunologic failure A lot of co-morbidities Important implication from DDI point of view New approaches, New mechanism New understandings New attitude New outcomes Source : A. Streinu-Cercel. cnlas.ro: Specific Challenges of the HIV Epidemic in Romania. EACS 2013. M. Mardarescu. Et All. Risk factors involved in late detection of HIV mother to child transmission - data from the National Registry of HIV pregnant women and perinatally exposed children in Romania. 2 nd Vilnius Summit on Communicable Diseases. Oct 4-7, 2017. 14 th Congress of the BADV, October 5-7, 2017. Vilnius, Lithuania.

Thank you!

The data is collected from the HIV/AIDS charts, sent by the nine Regional Centers for Evaluation and Monitoring of HIV/AIDS Data and by County Public Health Authorities, further processed by Compartment for Monitoring and Evaluation of HIV/AIDS data in Romania, in National Institute for Infectious Diseases Prof. Dr. Matei Bals

We would like to thank all our colleagues in the nine Regional HIV Centers as well as to the Virology and Immunology laboratories in INBI Prof. Dr. Matei Balş whose commitment and partnership sustained a large part of the National HIV Surveillance Programme

National Institute for Infectious Diseases Prof. Dr. Matei Bals Compartment for Monitoring and Evaluation of HIV/AIDS Data in Romania Manager: Prof.Dr. Adrian Streinu-Cercel Head of Infectious Diseases UMF Carol Davila Coordinator: Coordinator HIV/AIDS Programme: Medical Director: Mariana Mărdărescu MD PhD Lecturer Dr.Elisabeta Otilia Benea Dr. Sorin Petrea Statistical data operators : PC Operators: Epidemiology: In Collaboration with: As.med. Marieta Iancu Daniela Viţelaru Sanda Vintilă Dr. Ionel Iosif Claudiu Schiopu- Tessy Report Romanian HIV/AIDS Centre

References Continuum of HIV care. Monitoring implementation of the Dublin Declaration on Partnership to Fight HIV/AIDS in Europe and Central Asia: 2017 progress report https://ecdc.europa.eu/en/publications-data/thematic-report continuum-hiv-care HIV/AIDS Epidemic in 2016- Compartment for Monitoring and Evaluation of HIV/AIDS Data in Romania http://www.cnlas.ro/images/doc/31122016_rom.pdf A. Streinu-Cercel. cnlas.ro: Specific Challenges of the HIV Epidemic in Romania. EACS 2013. M. Mardarescu. Et All. Risk factors involved in late detection of HIV mother to child transmission - data from the National Registry of HIV pregnant women and perinatally exposed children in Romania. 2 nd Vilnius Summit on Communicable Diseases. Oct 4-7, 2017. 14 th Congress of the BADV, October 5-7, 2017. Vilnius, Lithuania