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EASL 2012: Boceprevir a Useful Option for Patients Who Did Not Respond to Earlier Hepatitis C Therapy

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A regimen of boceprevir with pegylated interferon and ribavirin achieved cure rates of between 40% and 68% in patients who did not respond to a previous course of hepatitis C therapy, data presented to the 47th International Liver Congress (EASL 2012) in Barcelona last week show.

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The addition of boceprevir to standard hepatitis C therapy (pegylated interferon/ribavirin) achieved a sustained virological response 24-weeks post treatment (SVR24) in 40% of individuals with a prior null response to treatment, in 56% of those who relapsed after an earlier course of therapy, and in 68% of patients with a prior partial response.

Factors associated with the success of treatment included baseline platelet count and viral load.

Boceprevir is a protease inhibitor which works directly against hepatitis C. Its use with standard therapy -- pegylated interferon and ribavirin -- has been shown to increase the chances of treatment-naive individuals achieving a sustained virological response to therapy.

However the treatment of individuals who have not responded successfully to standard therapy remains a challenge. There are hopes that direct-acting antiviral agents such as boceprevir will provide important new therapeutic options.

Investigators therefore designed a study involving 164 patients who had previously received an unsuccessful course of pegylated interferon and ribavirin therapy. All had HCV genotype 1 infection.

Approximately a third (31%) had a null response to prior treatment (viral load decrease < 2 log copies IU/ml after 12 weeks), 51% had a partial response (> than 2 log copies IU/ml decrease at week 12, but a detectable viral load at the end of treatment), and 15% had relapsed (undetectable viral load at end of therapy but rebounded subsequently).

The patients received 4 weeks of lead-in treatment with pegylated interferon and ribavirin, which was then combined with boceprevir (800 mg 3 times a day), for a further 44 weeks. The study’s primary endpoint was the proportion of patients who achieved a sustained virological response (undetectable viral load) 24 weeks after the completion of treatment.

Approximately two-thirds of the patients were men, their average age was approximately 50 years, and 10% had liver cirrhosis.

A total of 138 patients were included in the investigators’ final analysis. This included 53 patients who stopped treatment early: 32 due to treatment failure, 11 because of side-effects, and 10 for non-medical reasons.

Rates of treatment response differed according to earlier outcomes. Some 68% of patients with an earlier partial response achieved a sustained virological response. This compared to 56% of individuals who had relapsed after therapy and 40% of individuals with a previous null response.

Factors associated with a sustained virological response 24-weeks post-treatment in a multiple stepwise logistic regression analysis included previous response to treatment, higher baseline platelet count, male sex, and lower baseline viral load (below vs above 800,000 copies IU/ml).

Almost all patients (96%) reported side effects, and for 10% of patients these were serious. Treatment was discontinued by 7% of patients because of adverse events and a third required an adjustment in the dose of their medication. The most common side effects included anemia (48%), fatigue (47%), nausea (30%), and headache (27%).

Strategies for the management of anemia included dose modification (26%), therapy with erythropoietin (40%), and transfusion (2%).

"Boceprevir with pegylated interferon/ribavirin is efficacious in all 3 types of non-response: relapsers, partial responders and null responders," concluded the investigators. "The safety profile…was comparable to that previously reported."

4/27/12

Reference

JP Bronowicki, M Davis, S Flamm, et al. Sustained virological response (SVR) in prior peginterferon/ribavirin (PR) treatment failures after retreatment with boceprevir (Boc) + PR: PROVIDE study interim results. 47th International Liver Congress (EASL 2012). Barcelona, April 18-22, 2012. Abstract 11/204.