Late Breaking News
Triple Therapy for Hepatitis C: High Cure Rate, Greater Risks
“The VA recognizes that pharmacists are ideal for managing patients on HCV treatment. Hepatitis C-related patient education, testing, adherence counseling, management of comorbidities affecting HCV treatment (such as diabetes and smoking cessation), medication dose adjustments, drug-interaction and side-effect management are all roles that VA pharmacists are performing to help manage hepatitis C infected patients in VA,” Belperio said.
In recognition of that role, the VA conducted several intensive four-hour regional “boot-camp” trainings on HCV in 2011. As a result, the number of VA pharmacists with a scope of practice to manage HCV rose 30%.
The triple therapy requires heightened attention to potential drug-drug interactions and awareness of existing treatments that may contraindicate use of the therapy. “Both boceprevir and telaprevir are substrates and inhibitors of the hepatic enzyme, cytochrome P450 3A, and the drug transporter, P-glycoprotein, which predisposes these agents to many drug interactions,” Belperio said. “Patients may be at risk for increased toxicity or side effects from some common medications once boceprevir or telaprevir is added, such as those used for cholesterol, heart disease or blood pressure and some steroids.”
Pharmacists may recommend therapeutic substitutions such as replacing simvastatin with pravastatin in these instances.
In some instances, drug interactions may reduce the effectiveness of boceprevir or telaprevir, and compromise the chance of achieving a SVR. Boceprevir or telaprevir may render medications such as birth control pills and antidepressants less effective. Because ribivirin is potentially teratogenic, pregnant patients and their partners should not use the triple therapy. Patients and their partners also should use two non-hormonal methods of contraception throughout the course of treatment and for six months afterward, because of the dangers of pregnancy, according to the guidelines. Triple therapy also is not recommended for patients with HIV.
“These drugs also should not be used in patients on certain medications that are contraindicated because they are highly dependent on the Cytochrome 450 3A enzyme system for clearance from the body,” said Belperio. They should also not be used in any situation where the patient cannot take either pegylated interferon or ribavirin. Because boceprevir and telaprevir must be taken at the full dose to be effective, patients who are unable to tolerate the side effects or do not respond should be taken off the treatment entirely.
By alerting patients upfront that almost everyone receiving HCV antiviral therapy will experience some adverse effects, and, by counseling patients on ways to minimize or manage those effects, pharmacists can significantly improve adherence and SVR rates. In addition, Belperio notes that engaging patients in their treatment has also been shown to be beneficial.
The VA recently released patient-treatment booklets specific to boceprevir and teleprevir that explain the treatments themselves, how to take the medications, adverse effects, required monitoring, clinic visits and worksheets to track their progress.
“These targeted, patient-specific materials, along with other adherence aids, such as pill boxes, mobile alarms and timers, can help remind patients to take their medications on time,” while helping patients track their viral load and course of treatment, Belperio said.
 Center for Drug Evaluation and Research. Guidance for Industry Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment. Food and Drug Administration. September 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf
 Yee HS, Chang MF, Pocha C, Lim J, Ross D, Morgan TR, Monto A. Update on the Management and Treatment of Hepatitis C Virus Infection: Recommendations from the Department of Veterans Affairs Hepatitis C Resource Center Program and the National Hepatitis C Program Office. Am J Gastroenterol. Published online April 24, 2012.
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