2. Better Retention Rates Observed in Patients on Lopinavir than Atazanavir in Uganda
Kate Ssamula, Juan Gonzalez Perez, Jonathan Ikapule, Penninah Iutung
AIDS Healthcare Foundation, Kampala Uganda

3. Background
Long-term retention of patients on 2nd line therapy has received relatively little attention in the medical research field
There is limited data on failure of 2nd line therapy and the use of third-line ART in people living with HIV in resource-limited settings
We have limited access to third line ART in Sub-Saharan Africa so our aim is to make sure we optimize our 2nd line drug options
Uganda is one of the countries that lead the way in rapid scale up of ART therefore expecting it to have a considerable number of patients on 2nd line hence the need to determine retention on 2nd line ART.

4. Objectives
To determine the retention of all patients ever initiated on 2nd line therapy
To determine factors associated with attrition on 2nd line therapy
To determine the proportion of clients on 2nd line that still had viral suppression at the closure of the cohort

5. Methods

6. Methods Retrospective cohort study
Clients initiated on 2nd line therapy between January 2004 to December 2013
10 health facilities in different parts of Uganda:
Urban facilities- 2 in Kampala, Masaka and Soroti
Peri-Urban facilities- Kalisizo, Lyantonde
Rural facilities- Kakuuto, Gombe, Maddu and Rakai
Exclusions: clients initiated on 2nd line therapy for other reasons like;
Adverse effects to NNRTIs
Drug interactions
Pregnancy
Clinical trials as a reason for being on 2nd line therapy
Children 14 years and below

7. Methods T0 = Date client was initiated on 2nd line
T1= 30th December 2013
Routine monitoring tests were done for all clients who were due: CD4 and VL
Outcome status: Attrition while on 2nd line therapy
Kaplan-Meier curves were used to estimate the risk of attrition over time and Cox proportional hazard model was used to determine the factors associated with attrition on 2nd line

8. Definitions
An active client was defined as one whose last visit to the facility was within 3 months to the closing date of the cohort
A client was considered to be on 2nd line if they had a PI in their current regimen that had replaced a NNRTI and one NRTI had been changed
A client was considered as LTFU if they were absent for >90 days after his/her last scheduled appointment

9. Definitions
Retention on 2nd line was defined as a client who was alive and confirmed to be receiving 2nd line therapy as evidenced by the last clinic visit date and drug pick up
Attrition referred to a patient who was documented as having died or lost to follow up.

10. Definitions
Clinical failure was defined as a patient presenting with a new or recurrent WHO stage 4 condition
Immunological failure was defined as a fall in CD4 count to pre-therapy baseline CD4, persistent CD4 count < 100 cells or 50% fall from the on-treatment known peak value
Virological failure was defined as Plasma viral load above copies/ ml based on two consecutive viral load measurements after 3 months with adherence support

11. Results

12. Study participants Number Notes on status 983 (2.2%)
Total number of files reviewed out of 44,624 clients
-119 = 864
119 clients dropped because of lack of data on 1st line regimen
-143 =721
143 dropped due to reason of switching ART regimen not related to failure on 1st line treatment
-12 = 709
12 clients dropped due to lack of basic demographic data
-29 = 680
29 Clients below the age 15 years were dropped
-22 = 658
22 dropped due to lack of confirmed clinical outcome at closure of the cohort
658
Considered in final analysis

13. Characteristics at T0 Clients on 2nd line after exclusion N=658 Gender
Female 353 (53.6%)
Median Age in years (IQR)
38 (IQR: 31-45)
1st Line Regimen
NVP based 516 (78.4%)
EFV based 142 (21.6%)
Reasons for switching to 2nd line
VF- 286 (43.5%)
IF- 284 (43.1%)
CF- 88 (13.4%)
Median duration on 1st Line, Months (IQR)
28 (11-49)
Median CD4 before switch to 2nd line (IQR)
83 ( )
Median VL before switch to 2nd line Log 10 (IQR)
5.0 (IQR )

14. Characteristics at T1 2nd Line Regimen LPV/r -551 (83.7%)
ATV/r- 107 (16.3%)
Median duration on 2nd Line, Months (IQR)
18 (9-42)
Clinical outcome at the end of follow up
Active
504 (76.6%)
Deceased
99 (15.1%)
LTFU
34 (5.2%)
Transferred out
21 (3.2%)
Median current* CD4 n=566
Median= 324 (IQR: )
Median current* VL (Log 10) n=338
Median= 4.01 (IQR )
Clients found to be failing on 2nd line n=338
20 (5.2%)
Current CD4 was defined as a patient having done a CD4 count within 6 months to the closure of the cohort.

15. Results

16. Results Variable N=658 Rate (/1000 PYRS) HR (95% CI) P value Gender
Female
353
120.6
Male
305
122.9
1.02 (0.71 , 1.46)
0.916
 2nd Line Regimen
LPV based
551
109.1
ATV based
107
269.7
2.47 ( )
<0.001
Reason for switch VF
286
27.0 IF
284
309.6
9.23 ( ) CF 88
58.9
1.59 ( )
0.339
Other variables included in the model but were not significant were age, NNRTI Regimen, 1st
Line Regimen, CD4 count before 2nd line, location of the clinic

17. Summary and conclusions
Overall retention of clients on 2nd line was much better than documented retention studies done in SSA though majority are on 1st line therapy and shorter durations
Retention on 2nd line therapy was significantly better in clients taking LPV/r containing regimen even though both PIs are currently recommended 2nd line treatment
Patients with immunological failure as a reason for switching to 2nd line had a higher probability of attrition probably because of late detection of treatment failure

18. Summary and Conclusions
Inadequate access to VL monitoring and HIV genotype testing are currently major barriers to optimal management of patients failing second-line ART.
Early detection of treatment failure through routine monitoring is necessary if we want to maximize our 2nd line treatment options