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Provincial Government of the Western Cape

Long term follow-up on ARV treatment Outcomes and challenges at 48 months in Khayelitsha ,South Africa. - the experience in Khayelitsha. Provincial Government of the Western Cape Infectious Disease Epidemiology Unit, University of Cape Town M é decins Sans Fronti è res.

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Provincial Government of the Western Cape

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  1. Long term follow-up on ARV treatmentOutcomes and challenges at 48 months in Khayelitsha ,South Africa - the experience in Khayelitsha Provincial Government of the Western Cape Infectious Disease Epidemiology Unit, University of Cape TownMédecins Sans Frontières MSF Scientific day,June 1st 2006

  2. Khayelitsha township • Peri-urban township ~ 500.00 inh. • PMTCT started in 1999, HIV clinics in 2000 and ARV in 2001 • HIV antenatal rate ~ 30 % and TB incidence at 1750/100.000 • TB/HIV co-infetion rate at 72% • ~ 8000 patients on active file including 3800 patients on ARV

  3. Khayelitsha Antenatal HIV Prevalence1999-2005

  4. Impact of the scaling up strategy Number of new patients started on ART per year Median CD4 count on starting (IQR) by year of starting

  5. Children 0-14 years ART initiation by year Vertical transmission rate measured at 8.8 % (.PCR survey 2004, n=500)

  6. Mortality at 3,6,12 and18 months according to year ART initiated

  7. Median Cd4 cells counts at different time points Khayelitsha 2001-1005 n=3152

  8. Proportion of undetectable VL ( < 400 copies/ml) Khayelitsha 2001-1005 n=3152

  9. Retention in care at 48 months(on first and second lines)

  10. Lost to follow-up by time period according to year ART initiated

  11. Kaplan-Meier failure estimate 0.20 d4T 0.15 Proportion substituted due to toxicity 0.10 AZT NVP 0.05 EFV 0.00 0 6 12 18 24 30 36 Duration on drug in months Substitutions due to toxicity by drug Changed by 36 n months (%, 95% CI) d4T 1228 1065 471 113 18 9 5 16.5 (12.0-22.6) AZT 639 497 442 417 306 205 132 8.3 (6.3-10.9) NVP 977 828 385 129 104 89 63 7.4 (5.4-10.1) EFV 967 790 558 423 245 139 81 3.1 (1.8-5.5) 13th Conference on Retroviruses and Opportunistic Infections, Denver 2006

  12. Causes of toxicity-driven substitutions on D4T Kaplan-Meier failure estimate 0.100 0.075 Peripheral neuropathy 0.050 Proportion substituted due to toxicity 0.025 Other toxicities incl. lipodystrophy 0.000 0 6 12 18 24 30 36 Duration on stavudine in months Lactic acidosis / symptomatic hyperlactataemia Changed by 36mo Reason for subst. n (%, 95% CI) 1228 1074 484 118 20 11 6 8.7 (5.3-14.0) Hyperlactataemia/LA Peripheral Neuropathy 1228 1068 486 120 19 9 5 6.4 (4.0-10.2) Other 1228 1073 495 123 21 11 6 1.7 (0.6-4.6) Combined 1228 1065 471 113 18 9 5 16.5 (12.0-22.6) 13th Conference on Retroviruses and Opportunistic Infections, Denver 2006

  13. 500 400 316 Rate per 1000py 300 200 81 60 100 44 30 17 2 0 Everyone < 6 months >= 6 months Men >= 6 months Women >= 6 months Women< 75kg, >= 6 months Women >= 75kg, >= 6 months Rate of substitutions due to symptomatic hyperlactataemia/lactic acidosis 13th Conference on Retroviruses and Opportunistic Infections, Denver 2006

  14. Proportion of patients on second line • Regimen change on virological failure defined as 2 consecutive measures > 5.000 copies/ml • Each complete regimen interruption (for AE, CI or hospitalisation) results in increased risk of virological failure (AHR 3.2 [95% CI 2.0-5.1], p<0.001), controlled for baseline CD4 count.

  15. Needs coverage 3500 Demand at 70% Started ART 3000 2500 2000 1500 1000 500 0 1993 2001 1985 1987 1989 1991 1995 1997 1999 2003 2005 2007 2009 2011 2013 2015 • Inclusion rate needs to reach 3200 new patients/year by 2010 • Cumulative :3800 patients on HAART now while estimated 15.000 patients by 2010 • Based on existing 3 clinics model, > 5000 patients/clinic by 2010 • Based on existing doctor/nurses ration, unfeasible Source : ASSA model 2003

  16. Monitoring and evaluation : a triangular relation between clinic staff , Cape Town University and MSF Daily patient bookings Real time clinical records capture in each clinic fter each visit (dedicated clerk) Daily missed appointment and weekly defaulters list Monthly activity report Quarterly outcomes cohort report Data cleaning / integration of lab records Retrospective database analysis for specific operational research questions Clinic staff University of Cape Town /MSF epidemiologist

  17. Conclusions • More than 75 % of initial patients are still in care at 48 months including 18 % on 2nd line :while numbers starts to grow,there is no affordable and patient friendly second line available • While scaling up , challenges of managing large teams and initial signs of staff burn require innovative radical solution to cope with projected workload by 2010 • Long term D4t related toxicity requires an urgent revision of our guidelines • Universal access is possible in such high prevalence setting but tight monitoring together with reactive management lines are essential for ongoing adaptation of service with such explosive growth • Partnership for operational research in with UCT had a major influence on national policies and guidelines .It has improved MSF operational research standards and made results acceptable in a politically sensitive context

  18. Acknowledgements • Patients and staff at HIV clinics • Monitoring and evaluation team : University of Cape Town and MSF (Andrew Boulle, Katherine Hildebrand, Washifa Abrahams) • ARV task team, Western Cape Department of Health

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