Antiretroviral Drug Switches in an Integrated TB and

HIV Treatment Trial

Anushka Naidoo, Kogieleum Naidoo, Tanuja Gengiah, Nesri Padayatchi, Aarthi Singh, Munira Khan, Shiela Bamber, Gonasagrie Nair, Nonhlanhla Yende, Salim

Abdool Karim, on behalf of the SAPiT study team.

Overview

Background• Challenges of concomitant treatment of TB/HIV co-

infection include drug-drug interactions and overlapping toxicities

Study Design • Retrospective analysis of 561 TB/HIV co-infected

patients in the SAPiT trial initiated onto ART

Objective• Investigation of rates and reasons for switching of

first line ART drugs in TB/HIV co-treatment.

ResultsSummary of Single Drug Switches:

N=13

Initial Drug Reason for Switch Number of switches

Median Time to Switch*(months)

Months to Switch per AE*

Didanosine (ddI) Peripheral Neuropathy 3 6 (4-11) 4 (1-11)

N=6 Hyperlactaemia 1 12

4Pancreatitis 1

8Liver Abnormalities 1

Efavirenz CNS/Neuropsychiatric 3 5 (2-11) 4 (0.5-6)

N=4 Pregnancy 1 15

Zidovudine (AZT)

Anaemia 15 (2-8)

8

2 N=2 Hyperlactaemia 1

NevirapineN=1

Hypersensitivity Rash (with Grade 3 ALT)

1 8 8

Changes to Second Line Regimens N=22

EFV/3TC/ddI Virological Failure 22 11 (9-12)

* From ART initiation

Conclusion

• 6% of cohort switched from first line drugs– 1.8% due to toxicity or contra-indication– 4.2% due to virological failure

• Baseline peripheral neuropathy experienced 17 fold increased risk for single drug switches

• Low overall incidence of additive toxicities

• Low overall virological failure

AcknowledgementsWe thank, the individuals who guided, and supported the design and conduct of the trial, the University of KwaZulu-Natal Biomedical Research Ethics Committee and the South African Medicines Control Council for their oversight of the trial as well as participants, sponsors and CAPRISA eThekweni Treatment Team