Boceprevir a useful option for patients who did not respond to earlier course of 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 in Barcelona last week show.

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.


pegylated interferon

Pegylated interferon, also known as peginterferon, is a chemically modified form of the standard interferon, sometimes used to treat hepatitis B and C. The difference between interferon and peginterferon is the PEG, which stands for a molecule called polyethylene glycol. The PEG does nothing to fight the virus. But by attaching it to the interferon (which does fight the virus), the interferon will stay in the blood much longer. 

detectable viral load

When viral load is detectable, this indicates that HIV is replicating in the body. If the person is taking HIV treatment but their viral load is detectable, the treatment is not working properly. There may still be a risk of HIV transmission to sexual partners.


A shortage or change in the size or function of red blood cells. These cells carry oxygen to organs of the body. Symptoms can include shortness of breath, fatigue and lack of concentration.


Severe fibrosis, or scarring of organs. The structure of the organs is altered, and their function diminished. The term cirrhosis is often used in relation to the liver. 

treatment failure

Inability of a medical therapy to achieve the desired results. 

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 directly 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 genotype-1 infection.

Approximately a third (31%) had a null response to prior treatment (viral load decrease below 2 log10 copies iu/ml after twelve weeks); 51% had a partial response (greater than 2 log10 copies iu/ml decrease at week twelve, 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 four weeks of lead-in treatment with pegylated interferon and ribavirin, which was then combined with boceprevir (800mg three times a day), treatment lasting for a further 44 weeks. The study’s primary endpoint was the proportion of patients who achieved a sustained virological response (an 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 for treatment failure; eleven because of side-effects; and ten 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 (null response: no vs yes; p = 0.0093); higher baseline platelet count (>200,000) (p = 0.0017); male sex (p = 0.009) and a lower baseline viral load (below 800,000 copies iu/ml vs above 800,000 copies iu/ml; p = 0.073).

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 anaemia (48%), fatigue (47%), nausea (30%) and headache (27%).

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

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


Bronowicki JP 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, abstract 204, Barcelona, 2012.