Featured Research

from universities, journals, and other organizations

Telaprevir: Added benefit in certain patients with hepatitis C

Date:
September 5, 2012
Source:
Institute for Quality and Efficiency in Health Care
Summary:
The new drug telaprevir offers advantages in various groups of patients with chronic hepatitis C infection of genotype 1. The available studies provide proof, indications or "hints" of an added benefit. However, not only the probability but also the extent of added benefit varies, according to a new assessment.

The drug telaprevir (trade name: Incivo) has been available for treatment of chronic hepatitis C infection of genotype 1 since autumn 2011. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether telaprevir offers an added benefit compared with the present standard therapy.

According to the findings of the assessment, the new drug telaprevir offers advantages in various groups of patients with chronic hepatitis C infection of genotype 1. The available studies provide proof, indications or "hints" of an added benefit. However, not only the probability but also the extent of added benefit varies.

An addition to previous standard drug therapy

Hepatitis C viruses attack the liver and can trigger inflammation there. If this becomes chronic, cirrhosis can develop and liver function progressively deteriorates. Moreover, the risk of liver cancer (hepatocellular carcinoma, HCC) increases. The virostatic drug telaprevir inhibits the reproduction of hepatitis C viruses. Experts assume that if no viruses are detectable in the blood over a sustained period after treatment (sustained virological response, SVR), the risk of secondary disease is reduced.

Telaprevir is administered in addition to peginterferon alfa (immune-system enhancing drug) and ribavirin (virostatic drug), which are already on the market. In accordance with the approval status, different patient groups are treated for different periods, which was allowed for in the assessment. The dual combination of peginterferon alfa and ribavirin is the present standard therapy, and this was compared with the triple combination of these two standard drugs and telaprevir.

Studies largely only provide data on morbidity and adverse effects

Overall 3 relevant studies were identified. The outcomes considered were "mortality," "secondary complications of treatment (morbidity)," measured in the studies by means of the surrogate outcome "SVR," as well as "health-related quality of life" and "adverse effects."

The quality-of-life results for treatment-nave (i.e. previously untreated) patients without cirrhosis were not statistically significant. No evaluable data on this outcome were available for other patient groups. Due to the too short study duration, the event rates for mortality were too low in all patient groups to be able to draw robust conclusions.

Extent of added benefit cannot be classified on the basis of the surrogate outcome for morbidity

The extent of added benefit cannot be classified on the basis of the surrogate outcome "SVR." This parameter is not a patient-relevant outcome in itself and there are no studies in which SVR is validated as a surrogate outcome in accordance with the usual criteria employed by IQWiG. Nevertheless, the Institute accepts SVR in the context of this assessment as a surrogate for the reduced incidence of liver cancer. This is because it is currently accepted that patients with no detectable hepatitis C virus in the blood are at lower risk of liver cancer. However, it is not known how many cases of liver cancer can in fact be prevented by telaprevir and it is therefore unclear whether the added benefit can be classified as "minor" "considerable" or "major." According to the corresponding legal ordinance, the added benefit is thus "unquantifiable."

Under consideration of the beneficial and harmful effects of telaprevir, overall IQWiG reaches different conclusions for different patient groups.

Advantages for treatment-nave patients without cirrhosis who have a high viral load

Different results for morbidity were shown for treatment-nave patients without cirrhosis, depending on the viral load in the blood at the start of treatment. Proof of an added benefit of telaprevir was only determined for patients with a high viral load. However, the extent of the added benefit is unquantifiable as it refers to the surrogate outcome "SVR."

For treatment-nave patients without cirrhosis, the data also provide proof and an indication of greater harm due to the adverse effects "anaemia" and "rash" respectively, the extent being classified as "considerable" in the former and "minor" in the latter case. In the consideration of the beneficial and harmful effects of telaprevir, this did not lead to a restriction in the overall conclusion for patients with a high viral load, as these side effects were nearly exclusively classified as "not serious."

In contrast, for treatment-nave patients without cirrhosis who have a low viral load at baseline, the data provide an indication of lesser benefit of telaprevir versus the comparator therapy. This is due to the fact that an added benefit regarding SVR is not proven, so that only the harmful effects are taken into account.

An added benefit of telaprevir is not proven for treatment-nave patients with cirrhosis, as the manufacturer dossier did not contain any evaluable data.

Indication of an advantage also in patients with unsuccessful pre-treatment

Depending on the cirrhosis status, different results were shown for patients in whom treatment had so far been unsuccessful (non-responders). Regarding morbidity, the data provide an indication of an added benefit of telaprevir in patients without cirrhosis. The data only provide a "hint" of an added benefit in non-responders with cirrhosis. In this context, "indication" and "hint" refer to the surrogate outcome "SVR." Therefore the extent of added benefit is unquantifiable.

As in the case of treatment-nave patients without cirrhosis, indications of greater harm due to the side effects "anaemia" and "rash" did not lead to a restriction in the overall conclusion.

No additional benefit for relapsed patients

In patients without cirrhosis who relapsed after standard therapy, the treatment regimen deviated from the approval status. Consequently, the added benefit cannot be assessed on the basis of the available data so that an added benefit is not proven.

In patients with cirrhosis who relapsed, the data provide an indication of an added benefit regarding SVR. However, at the same time they also provide an indication of greater harm (extent: considerable) regarding serious adverse events. Under consideration of the beneficial and harmful effects of telaprevir, IQWiG concluded that overall an added benefit is not proven for this patient group.

G-BA decides on the extent of added benefit

The procedure for inferring the overall conclusion on the extent of added benefit is a proposal from IQWiG. The G-BA, which has opened a formal commenting procedure, decides on the extent of added benefit.

An overview of the results of the benefit assessment by IQWiG is given by the following extract (https://www.iqwig.de/download/A11-25_Telaprevir_Extract-of-dossier-assessment.pdf -- PDF, 653 kB). The website gesundheitsinformation.de, which is issued by IQWiG, provides easily understandable brief information (German version -- http://www.gesundheitsinformation.de/index.807.de.html).

The G-BA website contains both general information (http://www.english.g-ba.de/special-topics/pharmaceuticals/benefitassessment/) on benefit assessments pursuant to 35a Social Code Book V and specific information on the assessment of telaprevir (German version -- http://www.g-ba.de/informationen/nutzenbewertung/21/).


Story Source:

The above story is based on materials provided by Institute for Quality and Efficiency in Health Care. Note: Materials may be edited for content and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Telaprevir: Added benefit in certain patients with hepatitis C." ScienceDaily. ScienceDaily, 5 September 2012. <www.sciencedaily.com/releases/2012/09/120905135336.htm>.
Institute for Quality and Efficiency in Health Care. (2012, September 5). Telaprevir: Added benefit in certain patients with hepatitis C. ScienceDaily. Retrieved July 31, 2014 from www.sciencedaily.com/releases/2012/09/120905135336.htm
Institute for Quality and Efficiency in Health Care. "Telaprevir: Added benefit in certain patients with hepatitis C." ScienceDaily. www.sciencedaily.com/releases/2012/09/120905135336.htm (accessed July 31, 2014).

Share This




More Health & Medicine News

Thursday, July 31, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

House Republicans Vote to Sue Obama Over Healthcare Law

House Republicans Vote to Sue Obama Over Healthcare Law

Reuters - US Online Video (July 31, 2014) The Republican-led House of Representatives votes to sue President Obama, accusing him of overstepping his executive authority in making changes to the Affordable Care Act. Mana Rabiee reports. Video provided by Reuters
Powered by NewsLook.com
Despite Health Questions, E-Cigs Are Beneficial: Study

Despite Health Questions, E-Cigs Are Beneficial: Study

Newsy (July 31, 2014) Citing 81 previous studies, new research out of London suggests the benefits of smoking e-cigarettes instead of regular ones outweighs the risks. Video provided by Newsy
Powered by NewsLook.com
Dangerous Bacteria Kills One in Florida

Dangerous Bacteria Kills One in Florida

AP (July 31, 2014) Sarasota County, Florida health officials have issued a warning against eating raw oysters and exposing open wounds to coastal and inland waters after a dangerous bacteria killed one person and made another sick. (July 31) Video provided by AP
Powered by NewsLook.com
Health Insurers' Profits Slide

Health Insurers' Profits Slide

Reuters - Business Video Online (July 30, 2014) Obamacare-related costs were said to be behind the profit plunge at Wellpoint and Humana, but Wellpoint sees the new exchanges boosting its earnings for the full year. Fred Katayama reports. Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins