1. ZIMBABWE AIDS CARE FOUNDATION NEWLANDS CLINIC Virological Outcomes in Adult Patients on Second Line ART, at Newlands Clinic Dr S. Bote

2. Acknowledgements  Prof Ruedi Luethy, Dr C Chimbetete, Dr M. Pascoe, Dr C Kunzekwenyika and Mr T Shamu  Newlands clinic staff  Newlands clinic patients

3. Presentation Outline  The Newlands Clinic  Viral load monitoring  Summary of the review  Results  Conclusion  Recommendations

4. The Newlands Clinic  The Clinic is a family centred,nurse led clinic that treat HIV positive patients.  Currently we are looking after 5067 patients.  84%(4271) are on ART of which 13%(567) are on second line

5. Monitoring Patients on ART  Virological monitoring is the best way of monitoring a patient on ART  After starting a patient on ART VL suppression is expected to be achieved with 6 months  Optimal adherence is essential for this to be achieved

6. Interpretation of VL  VL can either be undetectable or detectable  Conventionally - undetectable VL is <50copies/ml depending on the type of machine and methodology  However at NC the lower limit of detection is 37copies/ml (Siemens kPCR)

7. Low Level Viraemia  LLV is when HIV-1 RNA is between 50- 1000copies/mL in patients who had achieved viral suppression on antiretroviral therapy  Patients with LLV are at an increased risk of developing subsequent virological failure  Ideally a patient should have a persistently suppressed VL

8. Virological Failure and High Level Viraemia  High level viraemia is defined as VL>1000copies/ml  Virological failure is defined as 2 consecutive viral load measurements >1000copies/ml  This happens either due to poor adherence or development of drug resistance which can either be acquired or transmitted

9. Virological Failure  Ongoing viral replication in the presence of suboptimal ART promotes the selection of further drug resistance mutations.  Among patients experiencing persistent low- level viraemia, those with viraemia >400 copies/mL and a history of ART experience are more likely to have virological failure.

10. Viral Load Re-suppression  A study in Khayelitsha,South Africa showed that 68% of patients failing second line therapy re-suppressed within 3months of enhanced adherence support(Garone et al,2013).

11. NC SOP for VL Monitoring  All patients have baseline VL at ART commencement  Routine VL measurements done every 6 months  Targeted VL offered to patients: o With suspected lack of adherence o With a documented decrease of CD4 by 50% from a measured peak CD4 o With a new or relapsing OI o Unexplained weight loss > 10%

12. Viral Load (VL) Monitoring  Routing VL is done at baseline, after 6 months and 6 monthly thereafter  If VL is found to be detectable it is repeated within 3 months  Patient failing first line are then switched to 2 nd line  Patient failing 2 nd line undergo enhanced adherence counselling while we wait for 3 rd line

13. 3 rd Line Regimen  MOHCC developing a protocol for patients failing 2 nd line ART and guidelines for 3 rd line therapy  2 drugs to be used for 3 rd line are now available  Raltegravir and Darunavir/ritonavir  Still deliberating on the 3 rd drug  NC is one of the 4 referral centres that will be managing patients on 3 rd line

14. Objectives of the Review  To determine the level of viraemia in adults above the age of 25 years who are on 2 nd line ART  To determine the effect of enhanced adherence support on the viral load

15. Methods  All adults patients on 2 nd line with a viral load test done from the period 1 August 2013 to 1 June 2014 were reviewed

16. Results  371 patients were adults taking second line ART

17. Patients on 2 nd line >6months  59%(221) of the adults have been on 2 nd line for at least 6 months  Minimum duration on ART was 9 months and maximum 70 months

18. Adults Patients on 2 nd Line ART

19. Adults on 2 nd line(>6months): virological status(n=221)

20. Duration on 2 nd Line (n=221)

21. Intervention for Patients Detectable on 2 nd Line  All 69(31%) patients are supposed to go through 3 month period of enhanced adherence counselling  The first 22 patients were asked to attend weekly adherence support groups and have completed their 3 months  The baseline and end of intervention VL were then compared

22. Effect of Enhanced Adherence Counselling Patient IDPre-intervention VLPost intervention 179700225700 21855037 372637 431137 5188456 610337 742037 823937

23. Reasons for Poor Adherence from the patients  Stigma(7)  Non disclosure(4)  Psychological problems(especially depression)(6)  Old age and lack of support(2)  Substance abuse(alcohol)(4)  Ignorance(2)

24. Conclusions  18% of patients on 2 nd line are virologically failing treatment(according to national and WHO guidelines)  13% have LLV and at risk of eventually progressing to virological failure  Adherence is the major cause of detectable viral load  Enhanced counselling may lead to re- suppression of VL

25. Recommendations  Routine VL should be done for all patients on ART  Strategies for maintain optimal adherence must be achieved for effective VL suppression  Enhanced adherence support for patients with detectable VL on 2 nd line should be done before a patient can be diagnosed of treatment failure requiring 3 rd line

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