CROI 2016 Abstract eBook

Abstract Listing

Poster Abstracts

536

Is HCV Elimination Possible? A Modeling Study of HIV-Positive MSM Sebastiaan J. Hullegie 1 ; Brooke E. Nichols 1 ; Bart J. Rijnders 1 ; Robert J. de Knegt 1 ; Jürgen K. Rockstroh 2 ; Charles A. Boucher 1 ; David A. van deVijver 1 1 Erasmus Univ Med Cntr, Rotterdam, Netherlands; 2 Medizinische Univsklinik, Bonn, Germany

Background: Hepatitis C virus (HCV) infections are common among HIV positive men who have sex with men (MSM). Acute and chronic HCV have traditionally been treated with peginterferon containing regimens. During the last year, direct-acting antivirals (DAAs) for chronic HCV treatment have become available. Contrary to peginterferon, DAAs have limited side-effects and high cure rates. Widespread use of DAAs could cure patients and prevent onward transmission, in turn reducing the HCV epidemic. Unfortunately, DAAs are expensive and treatment can be deferred until later stages of chronic infection. The aim of this study was to assess the epidemiological and economic impact of providing DAAs to all co-infected MSM compared to deferring DAAs until fibrosis stage F2 or F3. Methods: A deterministic mathematical model was calibrated to the Dutch HCV epidemic among HIV-infected MSM. We determined the epidemiological impact from 2015 to 2030 of providing DAAs (89%-100% cure rate) to all diagnosed patients. In the counterfactual scenarios, patients were treated with peginterferon and ribavirin in the acute stage. In patients that failed or refused, treatment with DAAs was initiated in stage F2 or F3. The costs, cost per infection averted and incremental cost-effectiveness ratios (ICER) were calculated from a societal perspective using a DAA price of €50,000 for a 12-week course. Results: Compared to deferring DAA treatment to stage F2 or F3, treating all patients will 1) avert 1060 infections (F2) or 1081 infections (F3), 2) reduce the incidence rate from 12/1000 to 5/1000 person-years (compared to a stable incidence of 12/1000 for F2 or F3) and 3) reduce the prevalence from 5% to 1.4% (compared to an increase to 6.5% for F2 or 7.6% for F3). Treating all patients will cost society €31 million (€27000 per infection averted) or €39 million (€32000) compared to deferring DAA-treatment to stage F2 or F3, respectively. The ICER is €53,000 (F2) or €58,000 (F3) per quality-adjusted life year (QALY). The economic impact depends on the price of DAAs: the costs ranges between €14 million (defer to F2, DAA-price of €30,000) and €50 million (F3, €60,000) and the ICER range between €24,000 (F2, €30,000) and €73,000 per QALY (F3, €60,000). Conclusions: Treating all diagnosed patients with DAAs will strongly reduce, but not eliminate, the HCV-epidemic among HIV-infected MSM. The major determinant for cost- effectiveness is the price of DAAs. 537 Primary Care Provider Interest in Treating HCV: A Mixed-Methods Study Oluwaseun Falade-Nwulia 1 ; Ayesha McAdams-Mahmoud 1 ; Risha irvin 1 ; Alex Niculescu 1 ; Kathleen Page 1 ; Carl Latkin 1 ; Monica Mix 1 ; David L.Thomas 2 ; Mark Sulkowski 1 ; Shruti H. Mehta 1 1 Johns Hopkins Univ, Baltimore, MD, USA; 2 Johns Hopkins Univ Sch of Med, Baltimore, MD, USA Background: There are over 3 million Americans infected with hepatitis C (HCV). Despite recent advances in HCV treatment, a major barrier to care remains a limited number of providers. Provision of HCV therapy by primary care providers (PCPs) could expand access by increasing the pool of treating clinicians. We characterize willingness and self-efficacy of PCPs to become HCV treaters in a city with high HCV prevalence. Methods: 271 PCPs were identified from 4 large federally qualified health centers and community clinics affiliated with a large academic center in Baltimore, MD. We administered an internet-based survey from September 2014 to February 2015; followed by qualitative interviews with 20 randomly selected PCPs. The survey assessed provider demographics, clinical practice site and agreement with the statement “HCV treatment should be provided by PCPs in the all oral HCV DAA era” based on a 5-point Likert scale. A composite score was created for PCP self-efficacy based on five questions on aspects of HCV care for a maximum score of 20. Factors associated with agreement were examined using odds ratios (OR). Qualitative transcripts were read by 3 investigators and themes identified. Results: 129 (48%) PCPs responded. The majority (71%) had an MD/DO degree, were white (60%), currently screen patients for HCV (88%) and refer patients for specialist care (86%). 14 (11%) had treated >1 patient for HCV in the prior year. Only 5 (4%) had a score of >15 consistent with high self-efficacy of being skilled in HCV care, and 36 (26%) a score of >10 consistent with average self-efficacy. Most reported no/limited knowledge of HCV care. Although only 20% agreed treatment should be provided by PCPs, 61% were interested in more HCV training. Willingness to provide treatment was strongly linked to having a high proportion of HCV-infected patients (>20% vs <20%; OR 4.5; 95% CI 1.7-11.6) and availability of other services at the primary care site including HIV treatment (OR 7.0; 95% CI 2.7-17.8), substance abuse treatment (OR 2.7; 95% CI 1.1-6.7), and mental health services (OR 4.8; 95% CI 2.0-12.1). HCV care barriers identified in qualitative interview include limited PCP knowledge of HCV care, access to treatment specialists, competing patient health care needs, and medication cost. Conclusions: These data suggest that the largest impact of PCP involvement in HCV care will be achieved by initially focusing HCV training on PCPs with a high burden of HCV infected patients and existing systems to support HCV care. 538LB High Efficacy of HCV Treatment by Primary Care Providers: The ASCEND Study Sarah M. Kattakuzhy 1 ; Chloe Gross 2 ; GebeyehuTeferi 3 ;Veronica Jenkins 4 ; Benjamin Emmanuel 5 ; Henry Masur 6 ; Shyam Kottilil 7 ; for the ASCEND Investigators 1 Inst of Human Virology at Univ of Maryland, Bethesda, MD, USA; 2 Inst of Human Virology, Bethesda, MD, USA; 3 Unity Hlth Care, Washington, DC, USA; 4 Family & Med Counseling Services, Washington, DC, USA; 5 Univ of Maryland, Baltimore, MD, USA; 6 NIH, Bethesda, MD, USA; 7 Univ of Maryland Med Cntr, Baltimore, MD, USA Background: The hepatitis C (HCV) care cascade in the US is limited by the number of specialists able to treat HCV. Given the advent of directly acting antiviral therapy, we conducted a large-scale, longitudinal trial to evaluate the efficacy and safety of primary care driven HCV treatment Methods: In this multi-center, open label, phase IV clinical trial, chronic HCV-infected patients of community health centers in Washington DC were identified by their providers, consented, and distributed in a non-randomized manner to receive treatment from either a specialist (ID/Hepatology), primary care physician (PCP), or nurse practitioner (NP). Providers underwent uniform training on IDSA-AALSD therapeutic guidelines. Patients were treated with ledipasvir and sofosbuvir (LDV/SOF) as per label. The primary outcome was defined as unquantifiable HCV RNA viral load 12 weeks after completion of therapy (SVR12). Adherence to visits at 4, 8, and 12 weeks (all -7 to +14 days), were categorized by a composite score of attendance. Statistical analysis included chi-squared or Fisher’s exact test and logistic regression using SAS, version 9.3

Poster Abstracts

Results: 600 patients began treatment with LDV/SOF fromMay to November 2015, with follow up ongoing. 14 patients discontinued treatment early, including 4 due to adverse events and 1 death unrelated to study participation. Patients were predominantly black (96%) and genotype 1a (72%); 24%were HIV/HCV-coinfected, 18%were treatment experienced, and 20%were CPA cirrhotic, with comparable baseline characteristics between provider groups. Of 181 patients with available results, 169 achieved SVR12 (93.4% per protocol; 86.7% intention-to-treat including early discontinued). Of 12 patients with virologic failure, 1 had breakthrough and 11 had relapse. There was no significant difference ( p =0.67) between per protocol SVR12 and provider type: NPs (47/49;95.9%), PCPs (36/38;94.7%), and specialists (86/94;91.5%). HIV status had no impact on SVR12 or SVR12 by provider type. Of 419 patients who completed 12 weeks of therapy, composite adherence was significantly associated with provider type: 50% in NPs, 41% in PCPs, and 19% in specialists ( P <0.001) Conclusions: For the first time, we demonstrate that HCV treatment administered independently by PCPs and NPs is safe and effective, inclusive of challenging subpopulations of the epidemic, and within the largest African-American cohort described to date. Community- based non-specialist providers could significantly expand the scale of HCV therapy

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CROI 2016