nationale hepatitisdag – 16 September 2014
behandeling en monitoring
wat kunnen we leren van andere specialismen?? Kees Brinkman
Amsterdam
“monitoring” in Nederland
waarom???
• maatschappelijke relevantie: – – – –
prevalentie / impact sterfte bedreiging kosten
• “kwaliteit”?
– ziektekostenverzekeraars – inspectie
• wetenschap
– inzicht in ziektes, beloop, behandeling
www.nationaalkompas.nl
monitoring van sterfte
bron: - CBS - overlijdensactes
www.nationaalkompas.nl
monitoring van kosten
bronnen: DBC/DOT, database verzekeraars etc
kwaliteit monitoring?? • grove data: – CBS: aantallen, geslachten, sterfte etc – DBC: aantallen, globale kosten etc – …..kwaliteit van de data?
• nauwkeuriger data – ook behandeling: – nierziekten – renine, dianet – kanker – IKNL – hiv - SHM
HIV monitoring
historisch
• 1981 “nieuwe” immuundeficientie – homomannen, Haitianen, IVDU, transfusées
• 1982 AIDS – veel sterfte, stigma – besmettelijk: angst
• 1987 AZT eerste medicijn • 1996 proteaseremmers – complex, duur, resistentie
HIV monitoring
historisch
• 1981 “nieuwe” immuundeficientie – homomannen, Haitianen, IVDU, transfusées
• 1982 AIDS – veel sterfte, stigma – besmettelijk: angst
• 1987 AZT eerste medicijn • 1996 proteaseremmers – complex, duur, resistentie
HCV
veel overeenkomsten
1996 – nieuwe medicatie wie ?? wie eerst ??
• nieuwe medicatie was duur, complex • expertise gewenst: resistentie, bijwerkingen • er was haast: veel sterfte, jonge mensen
aan tafel: VWS, patienten, behandelaren, industrie
• VWS besluit: – versnelde registratie alle hiv medicatie – medicatie alleen in handen van experts • in aangewezen centra
– registratie verplicht: ATHENA cohort – HIV-zorg = WBMV zorg (financiering)
HIV Monitoring Foundation characteristics • founded on November 11, 2001 • appointed by Minister of Health as the executive organisation for registration and monitoring of HIV-infected patients followed in the Dutch treatment centres • part of HIV care • financial coverage (government & insurance companies) for every patient entered: standard coverage lab.tests, HIV nurse, education, sample storage, monitoring
Activities •collection and maintenance of anonymous data •report to government and other organisations •make data available for treating physicians •provide data for scientific research
Registered HIV diagnoses Number per year since 1996: Stable number new registered diagnoses at around 1100 per year 2011: 1047, projected 1078 2012:
947, projected 1051
Cumulative number since 1996: 20,761 HIV-1 infected individuals with a registered date of diagnosis 294 children (0-12 yr), 195 adolescents (13-17 yr), 20,272 adults (≥ 18 yr).
17,006 currently in care
(end 2012)
Registered HIV diagnoses(end 2012) Transmission risk groups: • 67% MSM • 27% heterosexuals • 1% IDU
Age at time of diagnosis: MSM • ≥45 yrs: 31% • 18-24 yrs: 12% • 25-34 yrs: 29% Heterosexuals • ≥45 yrs: 32% • 25-34 yrs: 30%
cART: virologisch & immunologisch succes in treatment-naïve patients HIV viral load:
CD4 cell count:
1st line regiments ’95 - ‘00 ‘01– ‘06 ‘07 – ‘11 % on NNRTI % on PI % on INSTI
TDF/FTC once daily (qd)
2012
15,0 % 82,7 % -
52,3 % 38,4 % -
67,8 % 25,9 % 1,3 %
63,2 % 29,9 % 2,4 %
…..
…..
….
92%
0,9 %
29,1 %
77,9 %
87%
report 2013
AIDS and death • AIDS down significantly since cART, but still occurs
AIDS
• Mortality overall still higher than in gender- and agematched general population Mortality
• Mortality of patients successfully treated from an earlier stage of infection approaches that of general population
Increasing age of patients in care
• • •
Median age of patients in care = 47 years 50 years or older – 1996: 9% – 2013: 37% (6% ≥65 years) Expected increase in age-related comorbidities 18
Late presentation at entry into care remains frequent Late
• •
Advanced
2012: 43% late entry into care 2012: 26% entry into care with advanced HIV disease
Late = CD4 count <350 cells/mm3 or AIDS Advanced = CD4 count <200 cells/mm3 or AIDS
Causes of death
• • •
AIDS remains major cause – 25% (late presentation) Shift to non-AIDS causes - NADM (malignancies) and cardiovascular Ageing population – more comorbidities
20
HIV cascade in NL 120%
100%
100%
80%
69%
65% 56%
60%
52%
40%
20%
0%
PLWHA
diagnosed
in care
cART
suppressed
SHM monitoring • veel actuele data: sturingsinformatie – internationale participatie – overlevingsverwachting; levensverzekering – ontwikkelingen: bijwerkingen, ageing etc.
• richtlijn ontwikkeling – cohort analyses – vergelijkingen (beter: ACTG)
• kwaliteitstraject – SHM verankerd in zorg 22
Stichting Hepatitis Monitoring?? behoefte aan stuurinformatie – aantallen, ernst, testing, risicogroepen – dure medicatie: geen vergelijkingen – bijwerkingen – cohort analyses: vergelijking combi’s noodzakelijk - samenwerking = vertrouwen - privacy - kwaliteit
samenwerking USA/EU • per 12 sept 2014: 2185 patienten – SOF/SIM – SOF/SIM/RBV – SOF/RBV – SOF/P/R
n=831 n=226 n=645 n=366