Restricted Access and Delays to HCV Treatment Among Medicaid Patients in Louisiana

Background: Many people living with chronic Hepatitis C Virus (HCV) have seen delays in accessing treatment or been denied entirely due to Medicaid restrictions requiring patients to meet certain criteria prior to receiving approval for medication pre-authorization. Methods: This study identified a cohort of Medicaid-insured patients with chronic HCV infection within New Orleans, LA. Patient medical records were reviewed and information regarding HCV care was gathered. This study sought to determine the degree to which HCV care was delayed for this population and describe common reasons for prior-authorization denials for direct-acting antiviral (DAA) medications. Results: For this population of Medicaid-insured patients with HCV RNA assay-confirmed chronic infection, the average number of days it took to reach a specialist was three-times greater than the number of days it took to reach a primary care physician. After attending an appointment with a specialist to seek HCV care, patients experienced wait periods of an average of 150 days before being deemed eligible for treatment per Medicaid requirements. After being deemed eligible for treatment, patients experienced an average wait period of 194.4 days to initiation of treatment, with low fibrosis status being cited as the most common reason for treatment delay. Conclusion: This population of Medicaid-insured patients in New Orleans, LA with chronic HCV infection experienced delays in treatment related to reduced accessibility of a specialist who was eligible to request DAA prior-authorization. Prior-authorization was most frequently denied based on low fibrosis status or recent alcohol/drug use

HIV coinfection predicts failure of ledipasvir/sofosbuvir in treatment-naïve noncirrhotic patients with HCV genotype

The efficacy of licensed direct-acting antiviral (DAA) regimens is assumed to be the same for hepatitis C virus (HCV)–monoinfected patients (HCV-Mono) and HIV/HCV-coinfected patients (HCV-Co). However, the high sustained viral response (SVR) rates of DAA regimens and the small number of HIV-infected patients included in registration trials have made it difficult to identify predictors of treatment failure, including the presence of HIV. Methods. We compared treatment outcomes for ledipasvir/sofosbuvir (LDV/SOF) against HCV G1 in treatment-naïve HCV-Mono and HCV-Co without cirrhosis in a prospective registry of individuals receiving DAAs for HCV. Results. Up to September 2017, a total of 17 269 patients were registered, and 1358 patients (1055 HCV-Mono/303 HCV-Co) met the inclusion criteria. Significant differences between HCV-Mono and HCV-Co were observed for age, gender, and G1 subtype distribution. Among HCV-Co, 99.0% were receiving antiretroviral therapy. SVR rates for LDV/SOF at 8 weeks did not differ significantly between HCV-Mono and HCV-Co (96.9% vs 94.0%; P = .199). However, the SVR rate for LDV/SOF at 12 weeks was significantly higher for HCV-Mono than HCV-Co (97.2% vs 91.8%; P = .001). A multivariable logistic regression model including age, sex, liver stiffness, G1 subtype, HCV-RNA, HIV, and treatment duration showed the factors associated with treatment failure to be male sex (adjusted odds ratio [aOR], 2.49; 95% confidence interval [CI], 1.27–4.91; P = .008) and HIV infection (aOR, 2.23; 95% CI, 1.13–4.38; P = .020). Conclusions. The results of this large prospective study analyzing outcomes for LDV/SOF against HCV G1 in treatment-naïve noncirrhotic patients suggest that HIV infection is a predictor of treatment failure in patients with chronic hepatitis C.This work was supported by the Spanish AIDS Research Network (RD16/0025/0017), which is included in the Spanish I+D+I Plan and is co-financed by ISCIII-Subdirección General de Evaluacion and European Funding for Regional Development (FEDER), and the Fondo de Investigación de Sanidad en España (FIS)/Instituto de Salud Carlos III (Spanish Health Research Funds; PI17/00657)

J Clin Gastroenterol

Background:Limited information is available describing the uptake of direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection among patients in general US health care settings. We determined the proportion of HCV-infected patients in the Chronic Hepatitis Cohort Study prescribed DAAs in 2014, who initiated treatment and identified characteristics associated with treatment initiation.Methods:Uptake was defined as the proportion of HCV-infected patients with at least 1 clinical encounter in 2013 who were prescribed a DAA regimen during 2014 and initiated the regimen by August 2015. Using multivariable analysis, we examined demographic and clinical characteristics associated with receipt of DAAs.Results:The cohort comprised 9508 patients; 544 (5.7%) started a DAA regimen. Higher annual income [adjusted odds ratios (aOR) 2.3 for income > $50K vs. 5.88, 3.25 to 5.88, 2.0 to 3.25, respectively, vs. <2.0), genotype 2 infection (aOR 2.2 vs. genotype 1), pre-2014 treatment failure (aOR 2.0 vs. treatment-naive), and human immunodeficiency virus (HIV) coinfection (aOR 1.8 vs. HCV monoinfection) were associated with DAA initiation. Black race/ethnicity (aOR 0.7 vs. whites) and Medicaid coverage (aOR 0.5 vs. private insurance) were associated with noninitiation. Sex, age, comorbidity, previous liver transplant, and duration of follow-up were not associated with receipt of DAAs.Conclusions:Among patients in these general US health care settings, uptake of DAA therapy was low in 2014, and especially so among minority and Medicaid patients. Systemic efforts to improve access to DAAs for all patients are essential to reduce morbidity and mortality from HCV infection.U18 PS005154/PS/NCHHSTP CDC HHS/United States2019-03-21T00:00:00Z28590325PMC6427915vault:3166

Hepatitis C Screening

Hepatitis C virus (HCV) is the most common blood-borne pathogen in the United States. The “Baby Boomer” population, adults born between the years 1945 and 1965, is considered a high-risk population as 75% of adults with HCV were born within this timeframe. The U. S. Preventive Services Task Force (USPSTF) made it a Grade B recommendation in 2013 for all adults born in this birth cohort to be screened for HCV even if asymptomatic. Hepatitis C virus is associated with many negative sequela including liver fibrosis, cirrhosis, hepatocellular carcinoma, and death. With successful treatment regimens available that yield a 90-100% cure rate, it is prudent and recommended to screen this birth cohort. Eagle Ridge Medical located in Brighton, Colorado and its sister clinic located in Fort Lupton, Colorado do not currently have a standardized approach for HCV screening of this population. The researcher of this project has therefore implemented an approach for screening that includes an electronic health record (EHR) initiation of a screening alert (reminder) for the four physicians at these clinics. She also mailed an informative letter to this population that included information about the national recommendation and screening of this birth cohort in an attempt to increase screening rates at these organizations. This birth cohort includes adults born between the years 1945 and 1965. iv The researcher performed a chart audit of 5% of this population that included 1,906 patients in this birth cohort (N = 95) both before and after implementation of this project to compare screening rates. The researcher also performed a chart audit on patients who were seen in both of these clinics six weeks prior and six weeks after project implementation; 466 patients were seen in the six weeks prior to implementation and three of them had been screened for HCV (0.6%) and 421 patients were seen in the six weeks after the project implementation and 57 of them had been screened for HCV (13.5%). The researcher anticipated screening rates would increase after this project had been implemented--they did as they rose by 4.1% using the 5% systematic sampling method and 12.9% during the six-week study period in which one positive result was noted. Many of the individuals born within this population have many years left to live if successfully treated and ultimately deserve the opportunity to be screened for HCV and treated accordingly. The effects of this study are expected to have a positive impact for the future of this birth cohort. Identifying patients who are positive for HCV will allow them the opportunity for treatment and a high potential of HCV eradication as there is a 90-100% cure rate

A Cross-Sectional Study Comparing the Frequency of Drug Interactions After Adding Simeprevir- or Sofosbuvir-Containing Therapy to Medication Profiles of Hepatitis C Monoinfected Patients.

INTRODUCTION:This study compares the expected occurrence of contraindicated drug-drug interactions (XDDIs) when simeprevir (SIM)- or sofosbuvir (SOF)-containing therapy is added to medication profiles of patients with hepatitis C (HCV) monoinfection to quantify, in relative terms, the population-based risk of XDDIs. Second, this study identified the predictors of XDDIs when HCV therapies are added to medication profiles. METHODS:A cross-sectional study was performed among Veterans' Affairs patients. Inclusion criteria were: (1) age ≥18 years, (2) HCV infection, and (3) availability of a medication list. Patients with human immunodeficiency virus were excluded. Demographics, comorbidities, year of HCV diagnosis, and most recent medication list were collected from medical records. The primary outcome was the presence of XDDIs involving HCV therapy and the medications in the patient's home medication list after the addition of either SIM- or SOF-containing regimens. To define XDDIs, Lexi-Interact drug interaction software was used. RESULTS:4,251 patients were included. The prevalence of XDDIs involving SIM- or SOF-containing therapy were 12.6% and 4.7% (p &lt; 0.001), respectively. In multivariable analyses examining the predictors of XDDIs involving SIM-containing therapy, the only medication-related predictor was use of ≥6 home medications (odds ratio OR 4.58, 95% confidence interval CI 3.54-5.20, p &lt; 0.001). Similarly, use of ≥6 home medications was also the only variable associated with an increased probability of XDDI involving SOF-containing therapy (OR 3.83, 95% CI 2.57-5.70, p &lt; 0.001). CONCLUSIONS:Sofosbuvir-containing therapy had a lower frequency of XDDIs than SIM-containing therapy. Polypharmacy with various classes of home medications predicted XDDIs involving SIM- or SOF-containing therapy

CLINICAL FACTORS ASSOCIATED WITH HEPATITIS C TREATMENT SELECTION IN A VETERANS AFFAIRS POPULATION

Background: Hepatitis C virus is currently the most common chronic blood borne pathogen in the United States, with only half of those infected aware of their condition. The cost for treatment is higher with Harvoni® (ledipasvir/sofosbuvir) than Viekira Pak® (ombitasvir/paritaprevir/ritonavir and dasabuvir). With finite resources available to treat patients, it is important to understand which clinical factors may influence treatment selection decisions. Methods: The study is a 12-month medical record review within the Veterans Affairs (VA) system to evaluate significant relationships between selected clinical and sociodemographic factors and HCV treatment selection with either Harvoni® or Viekira Pak®. Clinical and demographic information was collected as well a presence of interacting medications, contraindication to components of the treatment regimen, and the treatment regimen indicated and selected. Results: In total, 25,717 patients were extracted from the database and were compared by the use of frequency charts and logistic regression analysis with results reflective of the nationally reported numbers. There was a statistically significant difference in the prescribing pattern between the VA Northern California Health System (station 612) and the other stations nationally with Viekira Pak® prescribed more often in that station. Station 612 utilized an electronic decision tree (otherwise known as a ‘quick order’) during the medication ordering process. In a comparison between station 612 and the other stations within the VA a notable difference in the impact of drug-drug interactions on the prescribing patterns was found within station 612. Conclusion: Many methods can be used to ensure optimal treatment for HCV infections. In station 612 the use of a decision tree may have assisted in avoidance of potentially modifiable factors which enabled for a higher utilization of the less expensive treatment option, Viekira Pak®, for HCV infections, thereby potentially allowing for more Veterans to be treated with finite resources

Clin Infect Dis

Most persons with chronic hepatitis C virus (HCV) infection in the United States are undiagnosed or linked to care. We describe a program for the management of Alaska Native patients infection utilizing a computerized registry and statewide liver clinics resulting in higher linkage to care (86%) than national estimates (~25%).20202020-04-17T00:00:00ZCC999999/ImCDC/Intramural CDC HHS/United StatesU01 PS001097/PS/NCHHSTP CDC HHS/United States31504307PMC7047515874

Hepatite C crônica: Terapêuticas atuais e possibilidades futuras – Revisão da literatura

A Hepatite C é uma patologia de etiologia viral, sendo uma das principais causas de Cirrose hepática e transplante de fígado no Brasil e no mundo. Com alta prevalência e índice de cronificação, a Hepatite C é um problema de Saúde Pública no Brasil, e seu tratamento tem sofrido modificações ao longo dos anos. O objetivo deste trabalho é revisar a literatura destacando a mudança na terapêutica da Hepatite C crônica, a importância e as vantagens da terapêutica atualmente utilizada, bem como as futuras possibilidades em estudo. Foi realizada uma revisão bibliográfica nas bases de dados eletrônicas LILACS e MEDLINE, entre 2010 e 2016. Durante anos o Interferon alfa foi utilizado, associado ou não, à Ribavirina, e depois ao Boceprevir e Telaprevir. Em função de avanços e questões relacionadas à segurança, posologia, custo, abrangência e efetividade, o novo Protocolo Clínico e Diretrizes Terapêuticas (PCDT) optou por descontinuar o uso desses medicamentos. Entretanto, adicionou-se à terapia do Sistema Único de Saúde (SUS) o Sofosbuvir, um inibidor da polimerase do vírus da hepatite C (HCV); o Simeprevir, um inibidor de protease de segunda geração; e o Daclatasvir, um inibidor da NS5A (poliproteína traduzida a partir do HCV). Essas novas opções terapêuticas atuam diretamente interrompendo a replicação do HCV, apresentam facilidade posológica, tratamento por menor período de tempo, menos efeitos adversos, menos exames de biologia molecular e melhores resultados. Além disso, permitem que o tratamento de pacientes coinfectados com HIV seja análogo ao de monoinfectados pelo HCV, e que pacientes em etapa de pré ou pós-transplante sejam atendidos adequadamente. O objetivo principal do tratamento é a erradicação do vírus, como também diminuir as complicações da cronificação e reduzir a transmissão do HCV. A cura com resposta virológica sustentada (RVS) passa a ser considerada após 24 semanas do final do tratamento quando utilizamos o Interferon. No tratamento oral livre de interferon, são necessárias apenas 12 semanas após o final do tratamento, para considerar o paciente com RVS. Diante do exposto, percebe-se que a terapia está passando por modificações importantes. Dentre as já aprovadas no Brasil em 2016, existe também a associação de Dasabusvir + Veruprevir e Ombitasvir. Espera-se, dessa forma, que num futuro próximo, com novas terapias mais eficazes, seja possível não só tratar, curar e prevenir a Hepatite C, mas também erradicá-la no nosso país e no mundo

Table 4-3. Considerations for hepatitis C cases who were organ (or tissue) transplant recipients*

Table 4-3 outlines considerations for hepatitis C cases who were organ transplant recipients. This table supports hepatitis C surveillance guidance from Viral Hepatitis Surveillance and Case Management: Guidance for State, Territorial, and Local Health Departments