1. IAS Education Programme at ICASA 2008 Lessons from Practice Paula Munderi

2. Background – what you have told us  Clinical Care Workers  ART clinics – mainly public sector (NGO)  Large Clinics (hundreds of patients)  More women than men  Some children  National ART Guidelines – basis WHO PH approach

3. Where do your patients come from ?  Clinical services (through PITC)  VCT services  CBOs of PWA  Other programs  PMTCT program  Nutrition rehabilitation centers - paediatrics

4. Initiation of ART – how do you assess your patients?  Clinical Staging  CD4 guided staging (<200 / <350)  VL – limited to research facilities  Baseline clinical tests  FBC, Liver function, Renal Function, Pregnancy Test, CXR ? Access to lab tests limited ? Lipids / Glucose – in the long term for PIs  ART preparedness & Counseling emphasized

5. The Selection of ARVs you use  1 st Line  2NRTI + NNRTI  Stavudine / Zidovudine / Lamivudine  N[d4T/AZT/3TC + NVP/EFV]  2 nd Line  2NRTI + bPI [Abacavir/ Tenofovir/ ddI + rLPV / NFV] Limited formulary – Focused procurement & Training ? The role of new ARVs

6. How you follow up your patients  Disease progression  Clinical assessment  CD4  VL ?  Side Effects  FBC, Liver and Renal function, Lactate  Adherence  Appointment keeping  Patient self report  Pill counts Monthly to 3 monthly visits ‘Fast Track Nurses’ for stable patients

7. Some of the challenges you have in common ….  Human Resources  Maintaining adherence – stigma, distance, SE’s  Family treatment – children  Access to medicines & Access to monitoring tests  Specialist support and referral for complex cases  Maintaining risk reduction and prevention  Alchohol and substance abuse  Alternative medicine: traditional / religious  Family planning

8. Case Study: Stigma as a barrier to Adherence. Jean Claude, Rwanda  Widespread stigma and fear of disclosure  Patients don’t seek care appropriately  Education, assisted disclosure, treatment companion and a multi disciplinary team approach ? Can we mix all consultation services so HIV +ve patients don’t feel isolated ?

9. Case Studies: Barriers to Adherence - Distance, Lack of Psychosocial support, Civil Unrest Joseph Gasper, Tanzania. Philip Owiti, Kenya I - Hard to reach populations II - So much for ‘pill counts’ !!! III – Civil unrest : Planning for it ?

10. Case Study: Side Effects of ARVs as a barrier to Adherence. Yeshiwork Mekuria Tefera, Ethiopia ‘Physical’ side effects of ARVs. ? What are some of these side effects? How these can be a barrier to adherence Strategies to handle these

11. Treatment of children Paediatric Case Presentation BOGNON TANGUY, Benin

12. Case Study: Treatment of Children Olawale Fadare, Nigeria  AM, 4yrs old girl; Mother HIV +ve and on ART  Father refused to test  No staging indicators; CD4 567 (21.5%)  ART deferred ; CTX prophylaxis; advised 6 mnth R/V  Started ART with Combivir BD from an alternative ‘private’ facility Action: Withdrawal of ART; Counseling and Education ? Was action appropriate …..

13. Case Study: Switching to 2 nd line Sunday Fagbnero, Nigeria The Challenge:  Viral load not available to all clients  ?Early identification of need to switch to 2 nd line ARVs Action:  A Viral Load Algorithm was developed to select patients likely to have failed the 1 st line medication.  Clinicians were trained to implement the algorithm and select clients for viral load  Those with elevated viral load are the switched to second line medication.

14. Case Study: Switching to 2 nd line Sunday Fagbnero, Nigeria Impact of solution: Led to early identification of clients failing on 1 st line ARVs and prompt switching to 2 nd line ARVs Lessons learnt: Limited resources can be better managed by focusing the main segment of the clients with specific need instead of deploying resources to all clients in the ARV service. ? In view of the large number of HIV positive clients and those requiring switching to second -line medication in ARV services,would it be feasible to provide regular viral load monitoring for all clients in care?

15. Case Study: Maintaining risk reduction and prevention. Sunday Fagbnero, Nigeria Challenges: Patients continue engaging in high risk behaviour while on ARVs. Risk of:  re-infection  development of resistant HIV strains  reduced uptake of ARVs among positive clients due to perception of ineffectiveness from observing poor response of clients on medication

16. Case Study: Maintaining risk reduction and prevention. Sunday Fagbnero, Nigeria Actions  Identification and training of Peer-Peer Educators  Trained on Basic of HIV Adherence and positive prevention activities Impact of action:  Improved uptake of positive prevention activities among clients  Reinforcement of positive prevention practices among clients selected Lesson Learnt:  HIV positive clients have great potential in contributing to improved health status of other clients.

17. ? Expert Patients Further Questions:  Are there other ways motivated PLWHAs can be utilised in improving the health status of other HIV positive clients?

18. Case study: Responding to patients’ socioeconomic challenges. Jules BB, Benin The unseen costs to patients of following ART Increased medical consultations Hospitalisation Diagnostic investigations Transport to clinics Food Socio – economic constraints that make treatment difficult and how one clinic has handled these.

19. Case Studies: The challenge of family planning and Desired Conception I Joseph Gasper, Tanzania II Ghada Shaka, Namibia

20. VirologicClinicalImmunologic Viral load CD4 count Clinical criteria "Early Switch""Late Switch" Failure / When to Switch

21. Clinical, CD4 Cell Count, and Virological Definitions of Treatment Failure for Patients on a First-Line Antiretroviral Regimen Clinical failure a Occurrence of new or recurrent WHO stage 4 condition b c CD4 cell failure d  Fall of CD4 count to pre-therapy baseline (or below) or  50% fall from the on-treatment peak value (if known) or  Persistent CD4 levels < 100 cells/mm 3 e Virological failure Plasma viral load >10,000 copies/ml f a.This event must be differentiated from the immune reconstitution inflammatory syndrome (IRIS) b.Certain WHO clinical Stage 3 conditions (e.g. pulmonary TB, severe bacterial infections), may not be an indication of treatment failure, and thus not require consideration of second-line therapy; c.Some stage 4 conditions ( EPTB: simple lymph node TB, uncomplicated TB pleural disease, esophageal candidiasis, recurrent bacterial pneumonia) may not be an indicator of treatment failure and thus not require consideration of second-line therapy; d.Without concomitant infection to cause transient CD4 cell decrease. e.Some experts consider that patients with persistent CD4 cell count <50/mm 3 after 12 months on ART may be more appropriate. f.The optimal viral load value at which ART should be switched has not been defined. However, values of more than 10,000 copies/ml have been associated with subsequent clinical progression and appreciable CD4 cell count decline.

22. WHO Clinical Staging Clinical Failure (CD4 and VL not available) Immunologic Failure (VL not available) Immunologic and Virologic Failure (CD4 and VL available) 1 N/A Do Not Switch Consider Switch 2 N/A Do Not SwitchConsider Switch 3 Switch 4 When to Switch from 1 st Line to 2 nd Line ARV Regimens for Treatment Failure Clinical failure is defined as a occurrence of new or recurrent WHO clinical stage 3 or 4 event (excluding IRIS). CD4 failure is defined as a fall to (or below) the pre-treatment baseline or a 50% drop from the on-treatment peak level or persistent levels < 100 cells/mm 3. Virological failure is provisionally defined as a plasma HIV-1 RNA level >10,000 copies/ml after a minimum of 6 months on therapy.

23. ART Failure Meeting: Major Conclusions Goal of ART in a Public Health Approach: Maximize survival with improved quality of life Time on ART considered (12 months, 24 months): Clinical: WHO Stage 3 or 4 after at least1 year on ART CD4 : confirmed CD4< 100-200 after 1-2 years (check/reinforce adherence before switching decision) HIV RNA threshold : Maintain 10,000 as a switch point (little immediate immune damage). Action when VL> 1,000 (adherence, toxicity, drug interaction assessment) and start to consider switching More efficient use of VL (targeted strategy) Adherence monitoring Confirm immunologic/clinical failure (?discordance) Pregnant women Use of "alert" criteria (clinical, immunologic and virologic)