The Impact of Boosted Darunavir Monotherapy on Neurocognitive Function and Quality of Life: Results from a Prospective Randomised Study

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1 21 st Annual Conference of the British HIV Association (BHIVA) April 2015, Brighton, UK The Impact of Boosted Darunavir Monotherapy on Neurocognitive Function and Quality of Life: Results from a Prospective Randomised Study Juan Tiraboschi 1 ; Liza Hamzah 2 ; Jose A. Munoz-Moreno 4 ; Helen Iveson 1, Martina Toby 1, Alastair Teague 3 ; R Kulasegaram 1 ; Frank Post 2 and Julie Fox 1 1.Harrison Wing, Guy s and St Thomas NHS Foundation Trust, London, UK 2.Mortimer Market, Central and North West London NHS Foundation Trust, London, UK 3.Kings College Hospital NHS Foundation Trust, London, UK 4.Fight against AIDS Foundation. Barcelona. Spain

2 Background A combination of three antiretroviral drugs is the standard of care for individuals with HIV infection. It has been suggested that once HIV suppression is achieved, a single active drug maintenance regimen might effectively suppress viral replication in some patients. To avoid potential NRTI toxicities, treatment simplification, and cost reduction. However, concern exists about long-term safety, especially in viral sanctuaries such as the central nervous system -Arribas J, Girard PM, Paton et al. Efficacy of PI monotherapy versus triple therapy for 1964 patients in 10 randomised trials. J Int AIDS Soc. 2014;17: European Guidelines for treatment of HIV-infected adults in Europe Gutmann C, Cusini A, Gunthard HF, et al. Randomized controlled study demonstrating failure of LPV/r monotherapy in HIV: the role of compartment and CD4-nadir. AIDS :

3 Objectives To investigate whether a treatment switch from a standard triple therapy of tenofovir, emtricitabine and efavirenz (Atripla) to darunavir/ritonavir monotherapy could impact on: a) neuropsychological tests b) quality of life c) sleep function

4 Methods Prospective substudy within a randomized, controlled, phase IV study. NP & QoL QoL QoL Week 0 Week 12 Week 24 Week 48 NP & QoL Atripla Darunavir monotherapy Randomised 1:1, open label Continued Atripla Asymptomatic, HIV RNA <50 copies/ml > 6 months Sleep

5 Methods II Neurocognitive performance -Attention (TMT-A), -Executive functioning (TMT-B) -Fine motor function, Grooved Pegboard (GPT) -The international HIV dementia scale (IHDS) Quality of life (MOS-HIV and EQ-D5) and depression/anxiety (HADS). Sleep function The Jenkins Sleep Evaluation Questionnaire.

6 Baseline Characteristics Total N=64 Atripla N=32 DRV/r N=32 Age years mean [SD] 42.7 [9.0] 43.8 [9.2] 41.6 [8.8] Sex male n [%] 54 [84.4] 27 [84.4] 27 [84.4] Ethnicity white/other n [%] 41 [64.1] 22 [68.8] 19 [59.4] Current smoker n [%] 15 [23.8] 9 [28.1] 6 [19.4] HIV transmission risk MSM n [%] 43 [67.2] 23 [71.9] 20 [62.5] Years diagnosed HIV median [IQR] 6.4 [3.9, 10.1] 7.1 [4.0, 9.5] 6.2 [3.9, 10.4] Prior AIDS diagnosis n [%] 11 [18.0] 5 [17.2] 6 [18.8] CD4 cells/μl At recruitment mean [SD] [194.2] [175.0] [214.1] Nadir median [IQR] [73.5, 275.5] [50.5, 252] [125, 319] Years on Atripla median [IQR] 3.5 [2.5, 3.9] 3.5 [2.4, 4.0] 3.3 [2.5, 3.8] DRV/r: boosted Darunavir monotherapy, SD: Standard deviation IQR: Interquartile range BMI: Body mass index MSM: Men who have sex with men AIDS: Acquired immune deficiency syndrome

7 Results Neurocognitive tests Outcome measure Baseline Week 48 Atripla DRV/r p-value Atripla DRV/r p-value Adjusted mean difference [95% CI] between arms from baseline to week 48 p-value Trail A (seconds) Trail B (seconds) GPB: dominant (seconds) GBP: non-dominant (seconds) IHDS score 24.5 [21.5, 31] 25 [17, 34.5] [21, 29] 23 [19, 32] (-4.2, 5.1) [43, 67] 51 [35, 62] [36, 52] 45 [34, 83] (-8.5, 12.8) [62.5, 76.5] 71.5 [63.5, 82.5] [59, 73] 67 [58, 84] (-10.3, 5.5) [71.5, 88] 78.5 [71, 92] [67, 88] 75 [71, 96] (-6, 10.2) [11, 12] 12 [11.3, 12] [11, 12] 12 [11.5, 12] [0.2, 0.7]

8 Results Quality of life Outcome measure Baseline Week 48 Adjusted mean difference [95% CI] between Atripla DRV/r p-value Atripla DRV/r p-value arms from baseline to week p-value 48 MOS HIV score median (IQR) Physical health 55.2 [52.1, 59.2] 53.8 [49.1, 59.8] [46.9, 56.7] 55.8 [51.7, 61.1] [-3.7, 3.5] 0.9 Mental health 57.2 [45.2, 61.1] 55.8 [50.6, 59.3] [46.3, 59.5] 54.9 [49.5, 62.2] [-2.4, 5.1] 0.5 EQ-5D visual analogue score (%) 85 [80, 95] 80 [70, 90] [65, 95] 80 [75, 95] [-5.8, 5.1] 0.9 EQ-5D total score 0.4 [0.1] 0.4 [0.1] [0.2] 0.4 [0.1] [-0.03, 0.05] 0.7 HADS anxiety score 5 [1.5, 7] 5 [2.5, 9] [1.5, 8.5] 4 [0, 7] [-3.9, 0.2] 0.03 HADS depression score 1.5 [0, 5.5] 2.5 [0, 5] [0.5, 5.5] 1 [0.0, 5.5] [-2.1, 0.9] 0.4 HADS total score 6.5 [4, 11.5] 7.5 [3.5, 14.5] [3, 13.5] 5 [ ] [-5.6, 0.6] 0.1

9 Sleep questionnaire 30 subjects in the Atripla arm and 26 subjects in the DRV/r arm completed the Jenkins Sleep Questionnaire at week 48. People on the Atripla arm had a significant lower score and thus worst sleep (median (IQR) score 9 (5, 12) for Atripla and 5.5 (0, 10) for DRV/r p=0.02).

10 Conclusions Subjects switching to DRV/r monotherapy did not affect neurocognitive function or quality of life compared to those continuing Atripla. Patients on DRV/r presented with significant lower Anxiety scores. At 48 weeks, those on DRV had significantly better sleep compared to those on Atripla.

11 Acknoledgements Participants Harrison Wing Staff Research Nurses Lisa Hamzah Jose Muñoz-Moreno Julie Fox

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