Cautious Optimism from Practitioners and Patients for New HCV Medications

Boceprevir and telaprevir offer new options for patients with chronic hepatitis C, but their complex dosing regimen may make adherence a challenge.

Boceprevir and telaprevir offer new options for patients with chronic hepatitis C, but their complex dosing regimen may make adherence a challenge.

The decade-long drought of new therapies for hepatitis C virus (HCV) ended on May 13, 2011, when the FDA approved Merck’s Victrelis (boceprevir). Now, another new medication, made by Vertex Pharmaceuticals and Johnson & Johnson, is poised for FDA approval. Vertex expects the FDA to make a formal decision on the New Drug Application for telaprevir, which will be marketed under the brand name Incivek, by early next week.

Both boceprevir and telaprevir have complicated dosing regimens and are associated with an array of potentially dangerous side effects, including fatigue, nausea, severe rash, and anemia. Both also offer greater potential for finding a cure for hepatitis C. But neither is a panacea for infected patients, partly because hepatitis C is difficult to treat, and partly because the side effects associated with both boceprevir and telaprevir are severe enough that they require combinations of medications to treat. More studies will be needed to determine whether these combinations are safe, and which of the two new medications is most effective.

According to the CDC, hepatitis C virus (HCV) infection is the most common chronic bloodborne infection in the United States, with more than 3.2 million people estimated to be infected with chronic hepatitis C.

Merck and Roche will work together to promote Victrelis and to explore development of new hepatitis C treatments from combinations of already-approved and experimental drugs. The combined potential market for Boceprevir and telaprevir is projected to be as much as $1 billion annually.

The addition of the new medications to the treatment arsenal means that the previous primary treatment regimen—peginterferon and ribavirin—will most likely evolve into triple combination therapy, with ether Victrelis and/or Incivek added to the combination. Both Victrelis and Incivek have demonstrated improvement over peginterferon and ribavirin alone, and both are meant to supplement current therapy. The cure rate of current treatment is around 50%. Both boceprevir and telaprevir, when added to the current standard treatment, offer the prospect of better cure rates.

Clinical trials in patients who have both HCV and human immunodeficiency virus (HIV) are ongoing, as are clinical trials that directly compare the effectiveness of boceprevir and telaprevir.

Merck and Vertex have proposed that most patients undergo response-guided therapy, under which length of treatment varies depending on patient response to the drugs. Previous therapy was typically 48 weeks, but research suggests that triple combination therapy could reduce treatment time to 28 weeks or less.

Patients and patient advocates have expressed concern that the complexity of the proposed dosing schedules may discourage physicians from prescribing the drugs. Although many patients appeared at the FDA Advisory board hearing to tout the new medications, despite many of them having experienced side effects, some clinicians remain concerned that patients experiencing side effects may try combinations of medication that are unsafe or discontinue hepatitis C treatment. Patient and clinician education will be a critical component of successful treatment.

For more information:

FDA websites for the boceprevir and telaprevir advisory committee meetings

Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease

A Comprehensive Strategy for the Prevention and Control of Hepatitis C Virus Infection and its Consequences

Diagnosis, Management, and Treatment of Hepatitis C: An Update

Hepatitis C Virus (HCV) Infection Testing for Diagnosis

Reference for Interpretation of Hepatitis C Virus (HCV) Test Results

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