Hepatitis C clearance with directly acting antivirals (DAAs) may be associated with acute decreases in hemoglobin A1c (HbA1c). We prospectively evaluated 251 chronic hepatitis C virus (HCV)-infected subjects (31% human immunodeficiency virus [HIV] positive) pre- and post-DAA therapy (median follow-up 28 months). Changes in HbA1c and glucose were minimal and did not differ by sustained virologic response (SVR), HIV, diabetes, or fibrosis. Following SVR, mean change in HbA1c was -0.022 ± 0.53%; however, total and low-density lipoprotein cholesterol increased significantly. Subjects with HIV had smaller transaminase reductions after SVR. Sustained benefits in glycemia were not identified following HCV clearance irrespective of HIV, diabetes, or fibrosis stage, whereas lipid alterations may warrant further investigation.

Objectives: The purpose of this study was to assess the feasibility and clinical impact of telemedicine-based opioid treatment with buprenorphine-naloxone following the Coronavirus disease 2019 pandemic. Methods: Participants included in this retrospective analysis consisted of adult New York City residents with opioid use disorder eligible for enrollment in the NYC HealthþHospitals Virtual Buprenorphine Clinic between March and May 2020 (n ¼ 78). Follow-up data were comprised of rates of retention in treatment at 2 months, referrals to community treatment, and induction-related events. Results: During the initial 9 weeks of clinic operations, the clinic inducted 78 patients on to buprenorphine-naloxone and completed 252 visits. Patient referrals included non-NYC Health þ Hospitals (n ¼ 22, 28.2%) and NYC Health þ Hospitals healthcare providers (n ¼ 17, 21.8%), homeless shelter staff (n ¼ 13, 16.7%), and the NYC Health þ Hospitals jail reentry program in Rikers Island (n ¼ 11, 14.1%). At 8 weeks, 42 patients remained in care (53.8%), 21 were referred to a community treatment program (26.9%), and 15 were lost to follow-up (19.2%). No patients were terminated from care due to disruptive behavior or suspicions of diversion or misuse of Buprenorphine. Adverse clinical outcomes were uncommon and included persistent withdrawal symptoms (n ¼ 8, 4.3%) and one nonfatal opioid overdose (0.5%). Conclusions: Telemedicine-based opioid treatment and unobserved home induction on buprenorphine-naloxone offers a safe and feasible approach to expand the reach of opioid use disorder treatment, primary care, and behavioral health for a highly vulnerable urban population during an unprecedented natural disaster.

Background Hepatitis C virus (HCV) and hepatic dysfunction are associated with low total and free testosterone (TT and FT) and high sex hormone-binding globulin (SHBG). However, little is known about changes in testosterone following successful HCV treatment. Methods We evaluated testosterone levels and the prevalence of low testosterone in a cohort of 327 men with chronic HCV infection (human immunodeficiency virus [HIV] coinfection = 150) and in a subset of 85 men with testosterone levels obtained pre-HCV treatment and after sustained virologic response (SVR). Median follow-up was 36 months. Results Participants with active HCV at baseline had higher TT (P < .0001) and SHBG (P < .0001) compared with participants who had achieved SVR, whereas FT did not differ. Low TT (<10.4 nmol/L) was more prevalent in participants with SVR compared with active HCV (P = .002); however, low FT (<0.1735 nmol/L) was common (50% active HCV, 43% SVR) and did not different between groups. For participants with longitudinal determinations, TT and SHBG decreased significantly (P < .0001) while FT remained unchanged post-SVR. Low FT persisted after SVR (pre-treatment 58%, post-SVR 54%, P = .72). HIV status and change in aspartate aminotrasferase-to-platelet ratio were significant independent predictors of change in FT following SVR. Conclusions During active HCV infection, testosterone deficiency may be masked due to elevated SHBG. Despite improvements in SHBG following SVR, low FT was common and persisted after HCV clearance, indicating the need for enhanced awareness and screening using estimates of FT following successful treatment of chronic HCV. Clinical Trials Registration NCT01350648.

Background: While acute changes in hepatic fibrosis are recognized shortly after achieving sustained virological response (SVR) using direct-acting antiviral therapies, long-term outcomes for the growing population of successfully treated patients with HCV remain uncertain. The aim of this study is to characterize long-term changes in fibrosis following SVR in patients with and without HIV and to identify potential factors associated with progression or regression of fibrosis. Methods: We completed a prospective longitudinal study of 162 subjects with HCV (34% HIV-coinfected) with pretreatment fibrosis stage determined by liver biopsy and post-SVR transient elastography. Progression of fibrosis was defined as a two-stage or greater increase in fibrosis, while regression was defined as a two-stage or greater decrease at last follow-up. The median duration of follow-up was 4.1 years. Results: Fibrosis progression occurred in 4% of subjects while regression occurred in 7% and 89% were stable and did not differ by HIV coinfection. Fibrosis progression was associated with increased body mass index (BMI), hepatic steatosis and smoking pack-years. In a multivariable logistic regression, HIV coinfection (P=0.009), lower steatosis score (P<0.05) and lower smoking pack-years (P=0.0007) were associated with a lower fibrosis score at last follow-up. Conclusions: We identify potentially important relationships between BMI, hepatic steatosis and smoking, and changes in hepatic fibrosis post-SVR in patients with and without HIV coinfection. Attention to modifiable risk factors such as body weight and smoking may reduce the risk of liver disease progression in the growing population of successfully treated chronic HCV patients.

The unexpected observation of increased hepatic steatosis with the administration of eplerenone led to early termination of the investigation. While limited because of the small number of participants and the open-label design, this study provides data to suggest that mineralocorticoid receptor antagonism with eplerenone may not be an effective approach to treat hepatic steatosis in human immunodeficiency virus or the general population. Additional research is needed to determine the pathophysiological mechanism behind these unanticipated observations.

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BackgroundPeople who inject drugs (PWID) have an increased risk for HIV, and HCV infection may foreshadow HIV acquisition in current epidemics. Studies of PWID have demonstrated a desire to obtain HCV treatment; however, use of pre-exposure prophylaxis (PrEP) in this population has not been well studied.MethodsThe ANCHOR study is an ongoing single-center study evaluating treatment of HCV in PWID. Enrolled patients have chronic HCV, opioid use disorder, and inject opioids. Patients are treated with sofosbuvir/velpatasvir and offered PrEP. Patients complete baseline community health worker (CHW)-administered surveys, physician assessment of PrEP eligibility, and are offered PrEP uptake.ResultsOf 89 enrolled patients, 49 (55%) met CDC criteria for PrEP, and 21 (24%) patients started PrEP. Reasons for not starting PrEP are in Figure 1. Though most patients are black (n = 82, 92.1%) and heterosexual (n = 81, 91%), these patients were less likely to start PrEP (P = 0.0068 and P = 0.0283, respectively). Baseline interest in starting PrEP was correlated with uptake (P = 0.0023), however, self-identifying as high-risk for HIV acquisition or meeting CDC criteria for PrEP were not. Though more patients endorsed sharing of injection equipment to a CHW than a physician (17% vs. 7%), endorsement to a physician rather than CHW was associated with starting PrEP (P = 0.0307). To date, 13 (62%) patients discontinued PrEP, 7 (54%) due to side effects.ConclusionPreliminary results of the ANCHOR study support that engagement in HCV care provides an opportunity for PWID to participate in PrEP intake; however, we found relatively low uptake in these patients, despite over half meeting CDC criteria. Our findings highlight the importance of counseling by physicians for initiation of PrEP, and suggest that improved communication between CHW and physician regarding risk behaviors could improve uptake. These data also reinforce that patients must be counseled and managed for side effects in order to retain them in care. Given the increasing opioid epidemic in the United States, more consideration needs to be given regarding how to incorporate PrEP into care, and how to effectively target and improve interest in PrEP for high-risk populations with poor uptake, including minorities and PWID. Disclosures C. Gross, Merck, Pfizer, Johnson and Johnson: Shareholder, stock. E. Rosenthal, Gilead Sciences, Merck: Grant Investigator, Grant recipient.

BackgroundHistorically, eradication of HCV with interferon-based treatments was linked with decreased incidence of diabetes. While viral clearance with direct acting agents (DAAs) may be associated with acute decreases in fasting glucose levels and hemoglobin A1c (HbA1c), there remains a need for larger prospective studies to address the longterm impact of sustained viral response (SVR) achieved with DAAs on glucose metabolism.MethodsProspective longitudinal cohort study of 251 subjects with chronic HCV (100% genotype 1a/b, 31% HIV+, 17% diabetes) evaluated pre- and post-DAA therapy with median follow-up of 28 mos. Change in HbA1c, glucose, lipid and transaminase levels were compared based on SVR, HIV, diabetes status and fibrosis stage.ResultsThere was no difference in change in HbA1c between subjects who achieved SVR (n = 241) compared with those who did not. Mean change in HbA1c did not differ from zero (−0.022 ± 0.53%) for those with SVR. Further, when subjects were grouped based on HIV, diabetes or fibrosis stage, there were no significant differences in changes in HbA1c or glucose following SVR. Subjects with HIV had smaller reductions in transaminase values (change ALT −33.3 ± 51 IU/L HIV+ vs. −47.8 ± 45 IU/L HIV-, P = 0.0007). Following SVR, total and LDL cholesterol increased (P = 0.0002 and P = 0.0003, respectively) whereas triglyceride levels decreased (P = 0.008). A greater proportion of subjects (7%) started or increased medication therapy for diabetes following SVR compared with the percentage who decreased diabetes therapy (3%). There was a statistically significant positive correlation between change in BMI and change in HbA1c (r=0.17, P = 0.006).ConclusionThe current study failed to identify sustained benefits in glucose or HbA1c in HCV treated patients, irrespective of HIV, diabetes or fibrosis stage. HIV infection blunted improvements in transaminase levels related to SVR. While HbA1c did not improve with HCV clearance, alterations in lipids were identified that warrant further investigation.Disclosures C. Gross, Merck: stock holder, Own stock; Pfizer: stock holder, Own stock; JohnsonandJohnson: stock holder, Own stock