Barriers to Treatment in HCV/HIV Co-infection Todd Wills, MD ETAC Infectious Disease Specialist HEPATITIS C TREATMENT EXPANSION INITIATIVE MULTISITE CONFERENCE CALL APRIL 17, 2013

Assessment of Alcohol and Substance Abuse Ongoing Alcohol use? Amount? Ongoing Substance Abuse? Amount? How much use is acceptable? What are individual clinic protocols?

Evaluating and Modifying Obesity Obesity is associated with nonalcoholic fatty liver disease and steatosis Insulin resistance may diminish response to interferon ? Weight criteria for treatment initiation ? What are individial clinic protocols?

Indicators of Decompensated Cirrhosis Development of ascites Variceal hemmorhage Hepatic encephalopathy* Jaundice Hepatocellular carcinoma* – Screen via ultrasound every 6 months for patients with cirrhosis or bridging fibrosis – * can occur even in incomplete cirrhosis Morgan T, Hepatitis Annual Update clinicaloptions.com – accessed

Evalution of Liver Status and Transplantation Referral Prognosis via MELD (Model for end stage liver disease) score should be assessed periodically Calculator available at: Score greater than 10 indicates need for possible liver transplantation referral

Absolute Contraindications to Therapy Uncontrolled active major psychiatric illness Hepatic decompensation (hepatic encephalopathy, coagulopathy, or ascites) Uncontrolled HIV with advanced immunosuppression (CD4 < 100 cells/mm3) Known allergy or severe adverse reaction to interferon and/or ribavirin

Absolute Contraindications to Therapy Women who are pregnant, nursing, or are of child- bearing potential and not able to practice contraception Men who have pregnant partners or partners of child-bearing potential and unwilling to practice contraception during treatment and for 6 months after treatment ends Active, untreated autoimmune disease (e.g., systemic lupus erythematosis) known to be exacerbated by peginterferon and ribavirin

Relative Contraindications to Treatment Significant hematologic abnormality: hemoglobin < 10.0 g/dl, absolute neutrophilcount < 1,000/μl, or platelet count < 50,000/μl CD4 <200 cells/mm3 Patients on dialysis or with a creatinine clearance <50 mL/min Uncontrolled diabetes mellitus Patients concurrently receiving zidovudine

Relative Contraindications to Treatment Autoimmune disorders (systemic lupus erythematosus, rheumatoid arthritis) Active substance use or ongoing alcohol use if interference with adherence is anticipated Untreated mental health disorder Hemoglobinopathies (e.g., thalassemia major and sickle cell anemia) Sarcoidosis Solid organ transplantation patients

Overcoming Barriers to Treatment Initiation Substance Abuse Counselors Opioid Dependence Treatment Patient Education Peer-Based Counseling Group Counseling Clinic Based Injections Any other specific clinic strategies?

Opioid Dependence Treatment methadone maintenance treatment – diminishes and often eliminate opioid use buprenorphine – office-based pharmacotherapy for opioid addiction – Physicians who complete a defined training can apply for a waiver to the Drug Addiction Treatment Act of 2000 National Institutes of Health Effective medical treatment of opiate addiction. NIH Consensus Statement 1997;15(6):1-38. Available at: Center for Substance Abuse Treatment Buprenorphine physician training events. Rockville, MD: Substance Abuse and Mental Health Services Administration, US Department of Health and Human Services; Available at:

Alcohol Use Intervention Brief interventions by medical providers focused on problem use of alcohol – client-centered counseling – reflective listening – nonjudgmental demeanor – Core elements include: assessing current levels of consumption providing education regarding risks assessing and facilitating motivation to alter alcohol consumption Bhattacharya R, Shuhart MC Hepatitis C and alcohol: interactions, outcomes and implications. J Clin Gastroenterol 2003;36:242-52

Patient Support Services Providing essential support services helps improve patient retention: case management transportation housing for the homeless Sherer R, Stieglitz K, Narra J, et al. HIV multidisciplinary teams work: support services improve access to and retention in HIV primary care. AIDS Care2002;14(Suppl 1):31-44.

Patient Support Services Specialized tools to improve adherence: – electronic reminder system – directly observed therapy – cash incentives for attending scheduled medical appointments Lorvick J, Edlin BR Program and abstracts of the 128th annual meeting of the American Public Health Association (Boston). Washington, DC: American Public Health Association; Effectiveness of incentives in health interventions: what do we know from the literature? Jani AA, Bishai WR, Cohn SE, et al American Public Health Association and Health Resources and Services Administration Adherence to HIV treatment regimens: recommendations for best practices. Available at: