Clinical Review

Hepatitis C: How To Fine-Tune Your Approach

Clinician Reviews. 2015 September;25(9):535-540

References

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36. Thomas AM, Kattakuzhy S, Jones S, et al. SVR durability: HCV patients treated with IFN-free DAA regimens. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February, 2015; Seattle, Washington. Abstract 653.

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The goal of HCV treatment is cure as evidenced by a sustained virologic response (SVR), which is defined as the absence of HCV RNA 12 weeks or more after completing treatment.^35,36 In general, for the most common genotypes of HCV, treatment with a DAA regimen results in a SVR in ≥95% of patients.¹⁸ Achieving SVR is associated with a 50% reduction in all-cause mortality, a 90% reduction in liver-associated mortality, and a >70% reduction in the risk of developing HCC.^27,37,38 SVR also has been shown to have a significant effect on reducing extrahepatic manifestations of HCV infection, such as cryoglobulinemia and lymphoma.^39-41

Barriers to HCV treatment

Current barriers to the newer, highly effective hepatitis C virus (HCV) infection treatments are largely financial. Although insurance companies have been able to negotiate substantial discounts from the high wholesale price of treatment, many insurance programs require prior authorizations and will approve treatment only for patients with advanced liver fibrosis. In our experience, many patients are left to wait for their liver disease to progress before their insurance company will agree to cover treatment.

In addition, many insurance companies have mandated that only subspecialists prescribe these medications. However, infectious diseases and hepatology specialists and their support staffs are often overburdened with paperwork and phone calls related to prior authorizations and justification of treatment, which can add to delays in treatment.

There is already evidence that treatment of all patients with HCV is cost-effective and leads to better healthcare outcomes⁴² and there are indications that these barriers will decrease over time, with prices already dropping significantly due to increasing competition between drug companies.

The DAAs are well tolerated and have good safety profiles. In phase III clinical trials of today’s most commonly used DAA regimens, the discontinuation rate was <1% in non-cirrhotic patients and 2% in those with cirrhosis.¹⁸ The most commonly reported adverse effects were nausea, fatigue, and headache. DAAs may have drug-drug interactions; therefore, careful medication reconciliation should be performed before initiating treatment.¹⁸

Prioritizing treatment. Current evidence supports treatment for all patients with HCV except those with a life expectancy of <12 months.¹⁸ Evidence indicates that treatment becomes less effective as a patient’s liver injury progresses to cirrhosis. Due to the high cost of available treatments, however, many insurers have imposed strict criteria for coverage. (See “Barriers to HCV Treatment,” above.⁴²)

Ordering the anti-HCV test with reflex to hepatitis C virus RNA decreases the number of blood draws and office visits required of the patient.

The highest priority for treatment has been given to patients with advanced liver fibrosis, compensated cirrhosis, those who have received a liver transplant, and those with severe extrahepatic manifestations (eg, mixed cryoglobulinemia and end-organ disease such as nephropathy). Treatment is also prioritized for high-risk populations (eg, patients with HBV and HIV co-infection, diabetes mellitus) and patients who are at high risk of transmitting the virus (eg, individuals who inject drugs or are incarcerated, men who have sex with men, women of childbearing age, hemodialysis patients, and health care professionals who perform exposure-prone procedures).¹⁸

While it may eventually become feasible for family physicians to treat HCV-infected patients, the rapid evolution and significant cost of treatment, as well as the challenges in obtaining insurance coverage, have kept HCV treatment largely in the domain of specialists, at least for now. In the interim, family physicians play a crucial role by screening, diagnosing, and counseling patients with this infection, referring them to specialty care, and providing ongoing monitoring for signs of HCC and esophageal and gastric varices.

CORRESPONDENCE
Laura Wangensteen, MD, Department of Family Medicine, Drexel University, 3401 South Market Street #105 A, Philadelphia, PA 19104; laura.wangensteen@drexelmed.edu