CROI 2016 Abstract eBook

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Poster Abstracts

Results: The 230 participants had median (IQR) adherence: SR 100% (100-100), TR 100% (95-107), PR-average 103% (95-105), PR-gaps 100% (95-100) and EAMD 86% (59-94) at week 48. Efavirenz concentrations were therapeutic (>1mg/ml) in 92%. Retention in care was 81% (186/230), with 83% (155/186) achieving HIV-RNA <40 copies/ml. EAMD, PR-average and PR-gaps best predicted virological outcome at week 48 with area under the ROC (AUC ROC) of 0.73 (095%CI 0.61-0.83), 0.73 (95%CI 0.61-0.85) and 0.72 (95%CI 0.59-0.84) respectively. EAMD, PR-gaps and PR-average were all highly predictive of resistance at week 48, with AUC ROC of 0.92 (95%CI 0.87-0.97), 0.86 (0.67-1.0) and 0.83 (95%CI 0.65-1.0) respective. SR, TR and EFV concentrations were poorly predictive of virological or resistance outcomes. Conclusions: Adherence data from EAMD and pharmacy refill measures predicted resistance and virological failure similarly. Pharmacy refill data is a reasonable option for monitoring adherence in resource-limited settings where electronic monitoring is unavailable.

1030 Adherence Predicts Failure on PI-Based Second-Line ART in Rural South Africa Dami A. Collier 1 ; Kathy Baisley 2 ; Dickman Gareta 3 ; Deenan Pillay 3 ; Ravindra K. Gupta 1 1 Univ Coll London, London, UK; 2 London Sch of Hygiene & Trop Med, London, UK; 3 Africa Cntr for Hlth and Pop Studies, Mtubatuba, South Africa

Background: Rollout of ART in sub-Saharan Africa has been accompanied by high prevalence of virological failure (VF) and resistance on NNRTI-based first line ART. This has led to increasing numbers being switched onto PI-based second line ART (SLART). The limited data on outcomes on SLART in sub-Saharan Africa are predominantly from urban settings. This study determined the incidence and risk factors for VF amongst second line patients receiving routine HIV care and treatment in a government program in a poor and rural setting in Kwazulu-Natal. Methods: Participants were HIV-1 positive adults >15 years initiating SLART between April 2007 and January 2014. They were identified from the Africa Centre’s ART Evaluation and Monitoring System. Their clinical data were anonymised and linked to the Africa Centre’s demographic information system. Exposures were adherence measured as a medication possession percentage (MPP); the duration on failing first line regimen; non-ownership of a refrigerator for storing soft gel lopinavir tablets. We defined VF as viral load (VL) >1000 copies/ml after 6 months of commencing SLART, or death or loss to follow up within 12 months without evidence of suppression (VL<1000). We used competing risk regression for analysis with other death as a competing risk. Results: Three hundred and fifteen adults started SLART. The median age was 33 (IQR 28-38) years and 72%were female. Unemployment was high (89.8%). Median CD4 at switch was 220 (IQR 113-342) cells/mm 3 . Nine patients with < 6 months follow up at January 2014 were excluded from analysis. The overall incidence rate of VF on SLART was 21.4 (95%CI 17.9-25.7) per 100 person-years. The cumulative incidence function of failure by 5 years was 45%. A higher MPP in the first 12 months of SLART was strongly associated with a lower risk of VF (sHR=0.67, 95%CI 0.45-0.99, and sHR=0.22, 95% CI 0.09-0.51, comparing 60-94% and ≥95%MPP, respectively, with <60%MPP, p<0.01). This association remained after adjusting for confounders. There was no evidence of an association with refrigerator ownership or duration on failing first line ART. Conclusions: There is a high incidence of VF on PI-based SLART in this rural setting with high unemployment. The level of adherence to treatment predicts VF. This has implications for the move to near universal, early ART in resource limited settings particularly as there is a lack of availability of third line ART. 1031 Outcomes of Patients Enrolled in ART Adherence Clubs After Viral Resuppression Joseph T. Sharp 1 ; LynneWilkinson 2 ;Vivian Cox 2 ; Carol Cragg 3 ; GillesVan Cutsem 4 ; Anna Grimsrud 5 1 Univ of Cape Town, Cape Town, South Africa; 2 Médecins Sans Frontières, Khayelitsha, South Africa; 3 Western Cape Dept of Hlth, Cape Town, South Africa; 4 Médecins Sans Frontières, Cape Town, South Africa; 5 IAS, Cape Town, South Africa Background: Eligibility for simplified models of antiretroviral therapy (ART) care and delivery have to date been limited to low-risk stable patients. There is no evidence whether such models also provide retention and adherence benefits for patients who have struggled to achieve or maintain viral suppression. Methods: Beginning in February 2012, a “Risk of Treatment Failure” (ROTF) intervention was implemented for patients with consecutive viral loads (VL) above 400 copies/mL at a high-burden ART clinic in Khayelitsha, South Africa. On their ART refill dates, ROTF patients attended a lay healthcare worker led group support session followed by a consultation with a nurse trained to provide integrated adherence and clinical management for patients failing ART. Patients who re-suppressed (VL<400 copies/mL) were enrolled in an Adherence Club (AC). ACs were comprised of ~30 stable patients who met 5 times per year and were facilitated by a lay healthcare worker who conducted a brief symptom screening and distributed pre-packed ART. We conducted a retrospective cohort analysis of patients who re-suppressed following the ROTF intervention and joined an AC. We describe patient characteristics and outcomes [mortality, loss to follow-up (LTFU) and viral rebound] using Kaplan-Meier methods with follow-up to mid-June 2015. Results: A total of 165 patients were enrolled in an AC following the ROTF intervention (81.8% female, median age 36.2 years). Seventy-nine percent (79.0%) were on second-line ART at AC enrolment. The median time from ART initiation to ROTF intervention was 3.4 years [inter-quartile range (IQR): 2.1-5.5 years) and from ART initiation to AC enrollment- 4.7 years (IQR: 3.4-7.2). Over the study period, two patients died (1.2%). Six-, 12- and 18-months after AC enrollment, retention in any form of care was 98%, 95% and 89%, respectively (Figure 1A). Thirty-six patients experienced viral rebound and 92%, 85% and 78%maintained viral suppression 6-, 12- and 18-months after AC enrollment (Figure 1B). Conclusions: Our findings suggest that patients who struggled to achieve or maintain viral suppression in routine clinic care can have good outcomes in simplified models of ART care and delivery following re-suppression. These simplified models may remove barriers imposed by clinician-led models such as transport cost and time. Further research is necessary to understand howmodels of care can better prevent viral rebound and support previously non-adherent patients.

Poster Abstracts

440

CROI 2016