CROI 2019 Abstract eBook

Abstract eBook

Poster Abstracts

505LB 12 MONTH OUTCOMES ON DOLUTEGRAVIR-BASED REGIMENS IN BOTSWANA: THE BEAT COHORT STUDY

Ava Avalos 1 , Tendani Gaolathe 2 , Dannae Brown 3 , Vani Vannappaggari 3 , Heston Phillips 4 , Pinkie Melamu 2 , Dinah Ramaabya 1 , Bornaparte Nkomo 1 , Kabo Matlho 5 , Kaelo Seatla 2 , Joseph N. Jarvis 6 , Sikhulile Moyo 2 , Mogomotsi Matshaba 7 , Simani Gaseitsiwe 2 , for the The Botswana Epidemiological ART Treatment Cohort Study Team 1 Botswana Ministry of Health, Gaborone, Botswana, 2 Botswana Harvard AIDS Institute Partnership, Gabarone, Botswana, 3 ViiV Healthcare, London, UK, 4 UNAIDS, Geneva, Switzerland, 5 University of Sydney, Westmead, NSW, Australia, 6 London School of Hygiene & Tropical Medicine, London, UK, 7 Botswana Baylor Children’s Clinical Centre of Excellence, Gaborone, Botswana Background: Botswana became the first country in Africa to implement a “Treat All” strategy using Dolutegravir based regimens (DBR) in June 2016. The Botswana Epidemiological ART Treatment Cohort Study (The BEAT), is an observational research cohort tracking virologic and clinical outcomes of people living with HIV (PLHIV) starting DBR. We present 12-month outcomes for treatment naïve, switched and highly treatment experienced patients (HTE) on DBR in routine care settings. Methods: Data were extracted from the Botswana Ministry of Health and Wellness electronic records and National HIV and laboratory databases from 11 urban and semi-rural facilities. Additional Information was extracted from clinic registers and patient files. Rates of adverse events (AEs) using toxicity grading scale of the Division of AIDS (DAIDS) 2017 v.2.1, Lost to follow-up (LTFU), death and viral load (VL) suppression (HIV RNA load <400 copies/mL) were assessed by site and treatment category. Results: A total of 2,257 PLHIV were included in this analysis: 1523 previously treatment naïve, 638 treatment switches and 140 HTEs. Median age was 39 years (range 32-48), 63%were women. Overall VL suppression was high among individuals initiating DBR within the past year (Table 1). AEs requiring intervention and treatment switch from DBR occurred in <0.1% (n=2) of treatment naive patients (severe itching and rash that resolved upon discontinuation of DBR) and 1 HTE patient (subsequently not considered related to DBR). All patients had advanced AIDS - cryptococcal meningitis, cervical cancer, and pulmonary TB with anemia of unknown origin. Deaths occurred in 1.3% (n=30) of patients. Men comprised 67% of all deaths. Average time to death was 43.7 days. No neural tube defects were recorded in 77 deliveries (11 receiving DTG before conception). Conclusion: The introduction of DBR in Botswana is associated with favorable clinical outcomes with high rates of viral load suppression at 12 months and few toxicities or evidence of treatment failure. These findings are reassuring and suggest that the decision to implement “Treat All” and introduce DBRs was an important step to controlling the HIV epidemic in Botswana. Efforts to maintain high retention in care and identify and treat pre-existing opportunistic infections prior to DBR initiation are critical, particularly with the introduction of same day initiations as part of the Treat All Strategy. Additional resources are also required to improve electronic VL laboratory results.

504 VIROLOGIC AND IMMUNOLOGIC OUTCOMES OF INTEGRASE INHIBITORS (InSTIs) IN RESPOND Bastian Neesgaard , for the International Cohort Consortium of Infectious Diseases: RESPOND Rigshospitalet, Copenhagen, Denmark Background: Although outcomes of INSTI use have been evaluated in several randomized controlled trials, experiences from large, demographically heterogeneous real-life settings are limited. Methods: Logistic regression was used to analyse virologic and immunologic outcomes from 1/1/12 to 1/10/17 among participants in the RESPOND cohort collaboration, starting an INSTI- compared to other contemporary non-INSTI containing regimens (efavirenz, rilpivirine, boosted darunavir- or atazanavir) with 12 months follow-up (FU) ± 3 months. Virologic outcomes were assessed by a composite endpoint (cVO) with success defined as viral load (VL) <400 cp/mL at FU and failure as ≥1 of either: VL ≥400 cp/mL, unknown VL, any antiretroviral treatment (ART)-regimen change, AIDS event or death. Immunologic success was defined as a 25% increase in CD4 count from baseline at 12 ± 3 months. Analyses were repeated at 6 ± 3 months. Sensitivity analyses using VL< 50 cp/mL for cVO success, excluding those with unknown VL or any ART change were also performed. Results: Of the 12568 persons included, 6156 were on an INSTI (2117 (34%) ART-naïve) and 6412 on non-INSTI regime (2616 (41%) ART-naïve). In an on-treatment analysis, 4982/5106 (98%) on INSTIs and 4979/5211 (96%) on non-INSTIs had a VL<400 cp/mL at 12 months (p<0.0001). A total of 7560 (60%) experienced cVO success (3850 (63%) on INSTIs and 3710 (58%) on non-INSTIs, P<0.0001). The most common reasons for cVO failure were any regimen change (1375 (22%) vs 1618 (25%), p<0.0001) and unknown VL (1050 (17%) vs 1201 (19%), p<0.0001). There were few viral failures (124 (2%) vs 232 (4%), p<0.0001), AIDS events (79 (1%) vs 122 (2%), p=0.008) or deaths (62 (1%) vs 44 (1%), p=0.6). After adjustment, the odds of cVO success at 12 months was significantly higher for persons on INSTIs compared to non-INSTIs (adjusted odds ratio 1.16 [95% CI, 1.07-1.26]), consistent for ART-naïve and ART-experienced with or without viral suppression at baseline (figure, p=0.4, interaction test). The odds of immunologic success at 12 months were also higher on INSTIs than non-INSTIs (1.18 [1.06-1.33]), consistent according to ART and VL status at baseline (figure, p=0.1, interaction test). Similar results were seen at 6±3 months and across all sensitivity analyses. Conclusion: In this large cohort collaboration, persons on INSTIs were more likely to achieve cVO success and immunologic success at 12 months, compared to non-INSTIs, although confounding by indication cannot be excluded.

Poster Abstracts

CROI 2019 188