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Randomised comparative study of patients tolerance of and adherence to Combivir and tenofovir versus stavudine lamivudine and tenofovir as HIV post- exposure prophylaxis(PEP)
Presented by David Hawkins, United Kingdom.
Hawkins D.1, Higgs C.1, Mandalia S.1, Nwokolo N.1
1Chelsea and Westminster Hospital, Sexual Health and HIV, London, United Kingdom
Objectives: Adherence to PEP regimens is considered highly important to their efficacy. Previous studies have not been randomised but have suggested that AZT and some PI (indinavir and nelfinavir) containing regimens are poorly tolerated. The aim of this randomised study was to compare the tolerability safety and adherence of 2 different thymidine analogue tenofovir based triple nucleoside/nucleotide combinations as HIV PEP.
Methods: We undertook an open label study of Combivir/tenofovir versus stavudine/lamivudine/tenofovir in patients being considered for HIV PEP. Enrolled subjects were asked to complete an Impact of Symptoms Scale and a validated adherence questionnaire on completing therapy which were analysed with non parametric and parametric tests respectively.
Results: A total of 74 patients were randomised 39 receiving an AZT containing combination and 35 receiving the alternate thymidine analogue d4t in combination.There have been no HIV transmissions to date. 14 patients prematurely discontinued treatment 6/39 in the AZT group and 8/35 in the d4t group.One in each arm switched their PEP to the alternate study arm. Adherence was otherwise good in both arms. However a higher prevalence of anxiety was observed in the AZT arm 69.6% and there was some evidence to suggest greater numbers of subjects experienced anxiety in this arm 14/39 (36%) compared to the d4t arm 6/35 (17%) p=0.069. Although a greater prevalence of nausea was observed in the AZT arm this was NS p=0.25 (59% v 43%). Moreover the AZT arm showed greater severity and recorded 90% (9/10) of the vomiting events p=0.03.
Conclusions: Our study has the benefit of being randomised and confirms that replacing AZT by d4t in a tenofovir based regimen leads to better tolerance. In view of its significant short term poor tolerability even with routinely prescribed antiemetics it might be wise to eschew the use of AZT in PEP regimens. Suitable combinations might be TDF/FTC or TDF/3TC along with d4t or better tolerated PIs.
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