Chronic hepatitis C: What are the advantages or disadvantages of boceprevir (Victrelis)?

Boceprevir was approved in mid-2011 for people infected with certain hepatitis C viruses. It is taken in addition to current standard therapy and aims to stop viruses from reproducing and thus prevent complications from hepatitis C.

For whom is boceprevir an option?

Boceprevir (trade name Victrelis) is an option for people with chronic hepatitis C where a certain type of virus (“genotype 1”) is detectable over a sustained period of time. The drug inhibits the reproduction of hepatitis C viruses.

Hepatitis C viruses attack the liver and can trigger inflammation there. In up to 80 out of 100 people with hepatitis C, the immune system cannot fight the virus successfully on its own. This leads to chronic inflammation of the liver; cirrhosis can then develop and liver function gets increasingly worse. Moreover, the risk of liver cancer increases. If no viruses are detectable over a sustained period after treatment, it is assumed that the risk of these complications has been lowered.

How is boceprevir used?

• Therapy starts with a 4-week preliminary treatment using the drugs peginterferon alfa and ribavirin. Peginterferon alfa is injected under the skin once a week. Ribavirin is taken daily as a tablet.
• After these four weeks, boceprevir (4 capsules three times a day) is to be taken together with a meal. This adds up to 12 capsules a day.
• How long the treatment lasts depends on the individual condition and the course of the disease, and can take up to 48 weeks.

What was boceprevir compared with?

IQWiG assessed trials that compared triple therapy consisting of boceprevir and the previous standard drugs peginterferon alfa and ribavirin, with dual standard therapy consisting only of peginterferon alfa and ribavirin. Similar to boceprevir, ribavirin also inhibits reproduction of hepatitis C viruses. Peginterferon alfa stimulates the immune system and promotes defense against virus infection.

Does boceprevir have advantages?

Advantages and disadvantages of boceprevir have only been studied in two groups of people in the first trials of sufficient quality. Both of these groups of people do not have liver cirrhosis:

People with chronic hepatitis C who have not been treated before:

• Complications: The trials presented did not last long enough to be able to assess what influence boceprevir has on complications. Boceprevir did reduce viruses in the blood, however: Out of 100 people who took boceprevir in addition to peginterferon alfa and ribavirin, 63 did not have any detectable viruses in their blood six months after treatment had ended. Without boceprevir, no viruses were detected in 38 out of 100 people. Because according to current knowledge, people without detectable infection have a lower risk of liver cancer, IQWiG regards this as an indication that boceprevir does have an advantage. It is unclear, however, in how many people boceprevir can in fact prevent liver cancer.
• Deaths: Data available so far are not sufficient to assess the effect boceprevir has on mortality.
• Quality of life: No adequate data are available on how boceprevir influences quality of life.

People with chronic hepatitis C who have not responded to previous treatment or who have had a recurrence:

• Complications: In this case, too, the trials presented did not last long enough to be able to assess what influence boceprevir has on complications. Boceprevir did reduce the number of viruses in the blood, however: In 59 out of 100 people who took boceprevir in addition to peginterferon alfa and ribavirin, no viruses could be detected six months after treatment had ended. Without boceprevir, no viruses were detected in 21 out of 100 people. IQWiG regards this too as an indication that boceprevir does have an advantage. It also remains unclear, however, in how many people boceprevir can in fact prevent liver cancer.
• Deaths: Data available so far are not sufficient to assess the effect boceprevir has on mortality.
• Quality of life: No adequate data are available on how boceprevir influences quality of life.

Not enough research has been done on the advantages and disadvantages of boceprevir if previous treatment has not had any effect at all on people with chronic hepatitis C. The same is true for people with hepatitis C who have liver cirrhosis.

Does boceprevir have disadvantages?

People with chronic hepatitis C who have not been treated before:

• Anemia: Compared with standard treatment, treatment with boceprevir led to anemia (low red blood cell count) more often, but this was severe only in few cases. Out of 100 people who took boceprevir, 49 developed anemia. In the comparator treatment, this side effect only occurred in 29 out of 100 people.
• Other side effects like infections or psychological effects were no more common in treatment with boceprevir than in standard treatment. The side effects of boceprevir, peginterferon alfa and ribavirin are listed on the respective package inserts.

People with chronic hepatitis C who have not responded to previous treatment or who have had a recurrence:

• Anemia: Compared with standard treatment, treatment with boceprevir led to anemia (low red blood cell count) more often, but this was severe only in few cases. Out of 100 people who took boceprevir, 43 developed anemia. In the comparator treatment, this side effect only occurred in 20 out of 100 people.
• Other side effects were no more common in treatment with boceprevir than in standard treatment. The side effects are listed on the respective package inserts.

Where can I get more information?

This text summarizes the most important results of a review by the German Institute for Quality and Efficiency in Health Care (IQWiG) published in December 2011. Click here (URL: https://www.iqwig.de/a11-17-boceprevir-nutzenbewertung-gemaess-35a-sgb.986.html?tid=1444&phlex_override_command=element&random=023aad) to read the entire review (in German).

The IQWiG review was commissioned by the German Federal Joint Committee (G-BA) as part of the “benefit assessment of pharmaceuticals pursuant to § 35a Social Code Book V”. In March 2012, G-BA passed a resolution on the benefit of boceprevir (Victrelis) on the basis of this review and the hearings received. You can find out more about the background of the benefit assessment and the G-BA resolution here (URL: http://www.g-ba.de/informationen/nutzenbewertung/8/#dossier) .

You can find the assessment for the drug telaprevir, which is also an option available to men and women with chronic hepatitis C, here (URL: http://www.informedhealthonline.org/here.807.en.html) .