CROI 2015 Program and Abstracts

Abstract Listing

Poster Abstracts

651 Majority of HIV/HCV Patients Need to Switch ART to Accommodate Simeprevir Rebecca Cope 1 ; Aaron Pickering 2 ;Thomas Glowa 1 ; Samantha Faulds 1 ; PeterVeldkamp 1 ; Ramakrishna Prasad 1 1 University of Pittsburgh, Pittsburgh, PA, US; 2 University of Maryland, Glen Burnie, MD, US

Background: The impact of drug-drug interactions (DDIs) between Simeprevir (SMV) and antiretrovirals (ART) in limiting HCV treatment among HIV/HCV co-infected individuals in clinical practice settings is unknown. We determined: a) the need to switch antiretroviral therapy (ART) prior to initiation of SMV; and b) the feasibility of switching ART to allow SMV use. We hypothesized that the majority of co-infected patients will require an ART switch and a safe and effective ART switch will be challenging in patients on a protease inhibitor (PI) based ART regimen. Methods: A retrospective chart review was conducted at the University of Pittsburgh Medical Center’s HIV/AIDS Program from June-August 2014. All patients with HIV and chronic HCV with a visit in the past 18 months were included. After collection of baseline characteristics, significant interactions between SMV and ART were identified based on available literature. If DDIs limited use of SMV, previous HIV genotype reports were reviewed to determine the feasibility of a safe and effective ART switch. Results: Of 133 patients, 71%were male, 54% African American, 23%met criteria for advanced liver disease, 86% had HCV genotype 1, and 94%were currently on ART. The distribution of regimens was: ritonavir-boosted PI (PI/r) (38%); efavirenz (34%); raltegravir (11%); rilpivirine (6%); elvitegravir/cobicistat (1%); and other regimens including dolutegravir (4%). An ART switch to allow use of SMV was required in 103 (77%), most frequently for patients on efavirenz or a PI/r. For 47 (46%), a straightforward substitution could be made. For the remaining patients, a switch following HIV expert opinion was viable in 40 (39%), but no switch was possible in 16 (15%) due to archived HIV drug resistance mutations. Notably, for more than 30% of patients on a PI, an ART switch was not feasible. Conclusions: The majority of HIV/HCV co-infected patients will require ART switch prior to use of SMV. Additionally, for nearly a third of patients on a PI, an ART switch may not be feasible. These findings are significant to real world clinical practice settings and highlight the complexity of using Interferon-free DAAs in this population and add further stress to an already burdened HIV care delivery system.

TUESDAY, FEBRUARY 24, 2015 Session P-N3 Poster Session

Poster Hall

2:30 pm– 4:00 pm Treatment of HCV with DAAs: Short-Term Costs and Long-Term Benefits 652 Simeprevir/Sofosbuvir vs Triple Therapy (Telaprevir or Boceprevir) for HCV GT1: A cost analysis

Jacob A. Langness 1 ; DavidTabano 2 ; SarahTise 3 ; Lindsay Pratt 3 ; Lauren Ayres 3 ; AmandaWieland 3 ; Sonia Lin 1 ;Vahram Ghuschcyan 2 ; Kavita Nair 2 ; Greg Everson 3 1 University of Colorado, Arvada, CO, US; 2 Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, CO, US; 3 University of Colorado, Aurora, CO, US Background: Simeprevir plus sofosbuvir (with or without ribavirin) (SMV/SOF) increases rates of sustained virologic response (SVR) over telaprevir- or boceprevir-based triple therapy (TT) (89-100% vs 64- 75%). Our objective was to examine the total treatment cost and cost per SVR of SMV/SOF versus TT. Methods: Patients were included if they had chronic hepatitis C, were infected with HCV genotype 1, and had been prescribed either SMV/SOF or TT between May 1, 2011 - August 1, 2014. Transplant recipients and HIV co-infected patients were excluded. Electronic medical records were used to collect data on: demographics, duration of HCV treatment, virologic response, clinic visits for treatment monitoring, HCV-related emergency room visits, and hospitalizations, treatment related blood transfusions, management of hematologic side effects by medications (epoetin alfa, filgrastim) and outpatient laboratory monitoring (estimated per clinic-defined treatment protocol). Unit costs for all medical services and labs were obtained from a national claims database IMS Lifelink with 8 million covered lives. HCV drug treatment costs were obtained from RED Book. SVR rates were defined by undetectable HCV RNA at 12 weeks (SVR12) for TT and at 4 weeks (SVR4) for SMV/SOF after end of treatment. Cost per SVR was calculated by dividing the mean total cost by the SVR rate. Results: There were 118 patients in the TT group (mean age = 53) vs 39 patients (mean age = 59) in the SMV/SOF group. Majority were male (54% in TT vs 59% in SMV/SOF) and Caucasian (86% in TT vs 94% in SMV/SOF). The SMV/SOF group had more advanced fibrosis (72% vs 57%), more treatment-experienced patients (64% vs 54%), and improved tolerability than TT. More TT patients (44% vs 0%) discontinued therapy for toxicity or virologic failure. An SVR4 rate of 87%was achieved in the SMV/SOF vs an SVR12 rate of 62% in the TT group. The cost per SVR4 in SMV/SOF group was $187,365 vs cost per SVR12 of $150,584 in the TT group. Majority of the costs in both groups were HCV drug costs, however HCV-related medical costs (outpatient, emergency room, and inpatient visits, laboratory monitoring, and hematologic side effect management) were 6 times higher in the TT group ($12,962 per patient) vs SMV/SOF ($2,279 per patient) (Table 1).

Poster Abstracts

Conclusions: This interim analysis shows SMV/SOF has more favorable efficacy and tolerability especially in more difficult-to-treat patients with HCV genotype 1 infection, but is associated with higher medication costs and cost per SVR.

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CROI 2015