CROI 2017 Abstract e-Book

Abstract eBook

Poster and Themed Discussion Abstracts

Results: 182 patients completed treatment for hepatitis C with PCPs at the four FQHCs from January 2015 to July 2016. Their genotypes include 1a/b, 2, 3, 4, and 6; 83% had genotype 1. 96% of the 112 patients with a viral load result at least 12 weeks after treatment completion had undetectable viral loads (SVR12). 64% of these patients had co-occurring mental health, substance use and/or chronic pain diagnoses; their SVR12 rate was 94%. There were four treatment failures among patients with behavioral health conditions and one treatment failure among patients without. Two patients stopped treatment early or were lost-to-follow-up, both with mental health conditions and chronic pain. Based on an intention-to-treat analysis, the overall SVR12 rate for this cohort was 94%. No statistically significant differences were found at the p<0.05 level. Please refer to the table for details. Conclusion: These data demonstrate that patients with co-occurring mental health, substance use, and chronic pain diagnoses can achieve similar rates of hepatitis C cure as those without these behavioral health conditions when treated by PCPs in “real world,” non-academic, non-specialist, community health center settings. 557 REAL-WORLD OUTCOMES OF HCV TREATMENT IN HOMELESS AND MARGINALLY HOUSED ADULTS Joshua A. Barocas 1 , Marguerite Beiser 2 , Casey Leon 2 , Molly Ingemi 2 , Paul McCabe 3 , Lena Cardoso 2 , Benjamin Linas 4 , James O’Connell 2 1 Massachusetts General Hosp, Boston, MA, USA, 2 Boston Hlth Care for the Homeless, Boston, MA, USA, 3 Quinnipiac Univ, North Haven, CT, USA, 4 Boston Univ, Boston, MA, USA Background: Homeless and marginally housed (HMH) adults have higher rates of HCV than those with stable housing, likely due to a high prevalence of substance use disorder. A national strategy to combat HCV infection requires approaches to reaching and treating HMH adults. We describe the real-world HCV treatment experience of a cohort of HMH adults. Methods: We retrospectively reviewed HCV treatment outcomes among the initial cohort of HCV-infected HMH adults treated with direct acting antivirals (DAA) at Boston Health Care for the Homeless Program (BHCHP). BHCHP is an urban community health center that provides care to over 12,000 individuals in the greater Boston area annually. BHCHP provides primary care and specialty services, including comprehensive HIV, HCV, and substance use treatment using a patient centered medical home approach. We used the electronic health record and manual chart review to extract demographics, characteristics of HCV and fibrosis, and treatment outcomes. Descriptive statistics were used to characterize the sample. Results: Sixty-five consecutive individuals who completed DAA therapy were included in this analysis. 51%were male (mean age 55). 60%were non-Caucasian and 23%were in transitional housing or residential treatment programs. 92% reported a history of substance use and 32% had a history of incarceration. 46%were HIV-coinfected with 93% virologic suppression. Most were genotype 1 (89%), 6%were genotype 2. 32%were Metavir ≥F4. Ledipasvir/sofosbuvir (LDV/SOF) was prescribed most often (50/65). Adherence was excellent; only 7 patients reported ≥4 missed doses. 97% of the patients (63/65) achieved SVR12. Patient 1 who failed therapy was genotype 2 with cirrhosis who was treated with SOF/ribavirin for 12 weeks prior to the recommendation that extended treatment in such patients to 16 weeks. Patient had undetectable VL at EOT. Resistance testing was not performed. Patient 2 was genotype 1 with cirrhosis (Fib4=4.3) treated with LDV/SOF for 12 weeks. The patient was undetectable at 4 weeks, but detectable at EOT. Resistance testing following failure showed H58P and L31V mutations. Conclusion: It is possible to successfully cure HCV in HMH adults with DAA therapy at a rate similar to that seen in clinical trials and other real-world cohorts despite significant additional barriers to health care. The national strategy to combat HCV infection should include treatment of HMH adults and develop best-practices for treating HCV in that population. 558 TREATMENT READINESS FOR HEPATITIS C INFECTION AMONG PWID IN CHENNAI, INDIA Eshan U. Patel 1 , Sunil S. Solomon 2 , Allison M. McFall 1 , Aylur K. Srikrishnan 2 , Amrose Pradeep 2 , Jungen Yi 1 , Oliver Laeyendecker 3 , David Thomas 1 , Mark Sulkowski 1 , Shruti H. Mehta 1 1 Johns Hopkins Univ, Baltimore, MD, USA, 2 YRG CARE, Chennai, India, 3 NIAID, Baltimore, MD, USA Background: Global hepatitis C virus (HCV) elimination will require widespread treatment of people who inject drugs (PWID). PWID have historically had limited HCV treatment uptake. Little is known, however, about residual barriers in the direct acting antiviral (DAA) era, particularly in low resource settings, some of which are implementing elimination programs. We examined barriers to HCV treatment among PWID in India, where treatment access is rapidly expanding through generic DAAs (current cost of treatment course: $600 USD). Methods: From 3/15-8/16, participants enrolled in an ongoing community-based cohort of current and former PWID in Chennai, India (n=542) completed a one-time questionnaire on HCV treatment barriers. At biannual follow-up visits, participants underwent a survey and lab testing including HCV & HIV antibody and RNA levels. Descriptive statistics were used to compare characteristics and survey responses. Results: 214 (39.5%) of 542 were HCV-infected and 162 (30%) HCV RNA positive. 28.5%were HIV/HCV coinfected. In a 13-item survey, we found moderate knowledge about HCV disease and treatment among HCV uninfected (mean score=6.55 [standard deviation (SD)=1.30]), HCV monoinfected (mean=6.75 [SD=1.42]; P=0.12) and HCV/HIV coinfected participants (mean=6.31 [SD=0.94]; P=0.03). Only 30% of HIV/HCV coinfected patients knew HCV was curable (compared to 57% of HCV monoinfected). Only 17 participants reported seeing a doctor and 2 a specialist who could treat HCV (total linked to care - 5.6%), 11 (5.1%) initiated and 10 (4.7%) completed treatment. 10 of the 11 with a treatment history were co-enrolled in a clinical trial of HCV treatment. The primary reasons people were not linked were worries/fears about treatment (HCV monoinfected) and competing financial priorities (HIV/HCV coinfected). Factors that improved willingness were pills (vs. injections), perceived efficacy, cost and location with a higher proportion preferring daily visits to a clinic vs. receiving a month’s supply (Figure 1). Willingness to take weekly interferon injections improved substantially with decreasing duration of treatment (60% for 12 weeks vs. 16% for 52 weeks). Conclusion: These data highlight residual gaps in knowledge and continuing perceptions related to interferon-based therapy, particularly among HIV/HCV coinfected PWID in India. Treatment rollouts need to incorporate educational initiatives and should consider a directly observed therapy (DOT), analogous to what is done for TB. 559 FIELD-BASED DELIVERY OF HCV THERAPY WITH MINIMAL MONITORING TO PWID IN CHENNAI, INDIA Sunil S. Solomon 1 , Amrose Pradeep 2 , Mark Sulkowski 1 , Aylur K. Srikrishnan 2 , Nandagopal Paneerselvam 2 , Shanmugam Saravanan 2 , Santhanam Anand 2 , Muniratnam S. Kumar 2 , David Thomas 1 , Shruti H. Mehta 3 1 Johns Hopkins Univ Sch of Med, Baltimore, MD, USA, 2 YR Gaitonde Cntr for AIDS Rsr and Educ, Chennai, India, 3 Johns Hopkins Univ, Baltimore, USA Background: In 2016, WHO released elimination targets for hepatitis C virus (HCV), but for these to be achieved, strategies must target those hardest-to-treat in low-and-middle- income countries (LMICs) such as people who inject drugs (PWID). Access in LMICs has improved with generic antivirals (~$200/28 days) but monitoring remains expensive (HCV RNA=$80; genotype=$90). We evaluated the feasibility of field-based directly observed therapy (DOT) with minimal molecular monitoring for delivery of HCV therapy to current and former PWID in Chennai, India, where genotype (GT) 3 or 1 infections are common. Methods: From 9/2015 – 3/2016, 50 PWID were randomized 1:1 to Arm 1: Sofosbuvir+Peginterferon+Ribavirin (SOF+PR) for 12 weeks or Arm 2: Sofosbuvir+Ribavirin (SOF/RBV) for 24 weeks. HCV RNA testing was done at baseline and 12 weeks after the end of treatment (EOT) to measure sustained virologic response 12 (SVR; HCV RNA<=”” div=””> Results: All were male; median age was 46; 2 were HIV co-infected and 20% had an elastography score >12.3 kPA (cirrhosis). Six discontinued (3 per arm) – none due to side effects (treatment completion in each arm: 88%). Of 44 who completed treatment, median missed doses were 2 with SOF+PR (range: 0-18) and 6 (range: 0-39) with SOF/RBV. All 22 who completed treatment with SOF+PR achieved SVR (88%: [22/25]). Of the 16 who completed SOF/RBV treatment and had SVR data at abstract submission, 11 achieved SVR (58% [11/19]). Of the HCV failures with SOF/RBV, 2 had GT1a and 3 GT3a infection; 4 had HCV RNA<=”” div=””> Conclusion: Field-based DOT of HCV therapy without real-time molecular monitoring was logistically feasible; however achieving 100% adherence was challenging. SOF+PR appeared superior to SOF/RBV in achieving SVR, especially in those who missed doses with no discontinuations due to side effects. In settings where injections are perceived more effective than pills and adherence may be challenging, there may remain a role for peginterferon in combination with oral direct acting antivirals for short treatment durations.

Poster and Themed Discussion Abstracts

CROI 2017 235