CROI 2016 Abstract eBook

Abstract Listing

Oral Abstracts

28

Initiating ART at a Patient’s First Clinic Visit: The RapIT Randomized Trial Sydney Rosen 1 ; Mhairi Maskew 2 ; Matthew P. Fox 1 ; Cynthia Nyoni 2 ; Constance Mongwenyana 2 ; Given Malete 2 ; Ian M. Sanne 2 ; Lawrence Long 2 1 Boston Univ, Boston, MA, USA; 2 Univ of the Witwatersrand, Wits Hlth Consortium, Johannesburg, South Africa Background: Very high rates of patient attrition from HIV care between HIV testing and ART initiation have been documented in sub-Saharan Africa. Our objective was to estimate the effect of accelerated initiation procedures on uptake of ART and viral suppression. Methods: We conducted a randomized controlled trial (RapIT Trial, NCT01710397) of immediate ART initiation in two public sector clinics in South Africa (a primary health clinic (PHC) and a hospital-based HIV clinic). Adult (≥18), non-pregnant patients receiving a positive HIV test or first CD4 count were randomized to standard or rapid initiation.

On the day of HIV test or first CD4 count, rapid arm patients received a point-of-care (POC) CD4 count (Alere Pima) if needed; those ART eligible received a POC TB test (Xpert MTB/RIF) if symptomatic, rapid POC blood tests (Roche Reflotron), physical exam, education, counseling, and ARV dispensing. Patients in the control arm followed standard clinic procedures (3-5 additional clinic visits over 2-6 weeks prior to ARV dispensing). Follow up was by passive medical record review. Primary outcomes were initiation of ART ≤ 90 days and viral suppression, defined as initiated, retained in care, and suppressed (≤400 copies/ml), ≤ 10 months of study enrollment. Results: Of 600 patients screened, 377 were eligible for ART and for the study (56% female, median age 35, median CD4 count 210 cells/mm 3 ). In the rapid arm 182/187 (97%) initiated ART ≤ 90 days, compared to 136/190 (72%) in the standard arm (RR 1.36; 1.24-1.49). In the rapid arm, 119/187 (64%) initiated and were suppressed at 10 months, compared to 96/190 (51%) in the standard arm (RR 1.26; 1.05-1.50). Adjustment for sex and baseline CD4 count did not affect results. Effects were larger for the PHC than for the hospital-based HIV clinic, for unemployed than for employed patients, and for patients under age 35 than for patients over 35. 72% of rapid arm patients initiated on the same day as HIV test or first CD4 count (Figure 1). All rapid arm patients in the rapid armwho did not start ART ≤ 180 days were delayed due to TB treatment. Time used for treatment initiation in the rapid arm averaged 2.8 hours.

Conclusions: Offering same-day ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%. It is feasible and acceptable in public sector clinics, and not all POC instruments will be essential in the future. It should be considered for adoption in high-volume clinics in the public sector in Africa. 29 Switching Tenofovir DF to Tenofovir Alafenamide in Virologically Suppressed Adults Joel E. Gallant 1 ; Eric Daar 2 ; Francois Raffi 3 ; Cynthia Brinson 4 ; Peter Ruane 5 ; Edwin DeJesus 6 ; MingjinYan 7 ; Andrew Plummer 7 ; Andrew Cheng 7 ; Martin S. Rhee 7 1 Southwest Care Cntr, Santa Fe, NM, USA; 2 Univ of California Los Angeles Med Cntr, Torrance, CA, USA; 3 Chu Hotel Dieu-Chu De Nantes, Nantes, France; 4 Central Texas Clinical Rsr, Austin, TX, USA; 5 Peter J Ruane MD, Inc, Los Angeles, CA, USA; 6 Orlando Immunology Cntr, Orlando, FL, USA; 7 Gilead Scis, Inc, Foster City, CA, USA Background: Emtricitabine/tenofovir DF (F/TDF) is a standard-of-care nucleoside reverse transcriptase inhibitor (NRTI) backbone due to its favorable efficacy and safety profile. However, TDF can be associated with renal and bone toxicities. Tenofovir alafenamide (TAF) is a novel tenofovir prodrug that achieves 91% lower plasma tenofovir levels than TDF. In elvitegravir/cobicistat/F/TAF phase 3 studies, TAF had less adverse effect on kidneys and bone than TDF. Methods: We conducted a 96-week (wk) randomized, double blind, active controlled study in virologically suppressed HIV-1 infected patients receiving F/TDF-containing regimens to evaluate the efficacy and safety of switching from F/TDF to F/TAF vs continuing F/TDF while remaining on the same third agent. Primary endpoint was virologic success at Wk 48 by ITT FDA snapshot algorithmwith a pre-specified noninferiority margin of 10%. We describe the Wk 48 data. Results: 663 patients were randomized and treated (F/TAF 333 vs F/TDF 330); median age 49 years, 15%women, median estimated glomerular filtration rate (eGFR) 100 mL/min. 46%were on a boosted protease inhibitor, 28% on an integrase inhibitor, 25% on a non-NRTI. Through Wk 48, virologic success (HIV-1 RNA <50 c/mL) was maintained in most patients in both treatment groups: F/TAF 94.3% vs F/TDF 93.0% (difference +1.3%, 95% CI: -2.5% to +5.1%), demonstrating noninferiority of F/TAF to F/TDF (Table). Emergent resistance was rare (0.3% vs 0). Drug related serious adverse events were rare (0 vs 0.3%). Drug discontinuation due to adverse events (AEs) was low (2.1% vs 0.9%). There were no cases of proximal renal tubulopathy in either group. Median eGFR improved by +8.4 mL/min in the F/TAF group vs by +2.8 mL/ min in the F/TDF group (P <0.001). Quantitative measures of proteinuria improved in the F/TAF group but not in the F/TDF group (Table). Bone mineral density (BMD) increased in the F/TAF group but declined in the F/TDF group: hip (mean) +1.14% vs -0.15% (P <0.001) and spine +1.53% vs -0.21% (P <0.001), respectively. More patients in the F/TAF group had ≥ 3% improvement in BMD at Wk 48: hip 17% vs 9% and spine 30% vs 14%. Conclusions: In virologically suppressed patients switching from F/TDF to F/TAF, high rates of virologic suppression were maintained, while renal and bone safety parameters improved. With its safety benefits relative to F/TDF, F/TAF has the potential to become an important NRTI backbone for antiretroviral treatment.

Oral Abstracts

9

CROI 2016