Navigation Links
Boceprevir: Indication of added benefit for specific patients

The active ingredient boceprevir has been available since the middle of 2011 as a treatment for chronic hepatitis C of genotype 1. 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) has now examined to establish whether boceprevir offers added benefit in comparison with the previous standard therapy. According to this assessment, the dossier submitted by the pharmaceutical company provides indications of added benefit for patients who have not yet developed liver cirrhosis. However, the extent of this added benefit cannot be classified.

The pharmaceutical company provided no data - or inadequate data - for two other indications - patients with liver cirrhosis and patients for whom prior treatment was totally ineffective (zero response to prior interferon-based therapy) - and therefore added benefit for these patients is not proven.

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. Boceprevir (trade name Victrelis, manufacturer MSD Sharp & Dohme) 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.

Boceprevir is administered in addition to the active ingredients peginterferon alfa and ribavirin, which are already on the market. In accordance with the approval status, different patient groups are treated for different periods, as was allowed for in the assessment. The dual combination of peginterferon alfa and ribavirin has been the standard therapy and this was compared with boceprevir given in a triple combination with the former two drugs.

Reduction in secondary diseases: extent cannot be classified.

For the two indications of pretreated (treatment-experienced) and non-pretreated (treatment-naive) patients without cirrhosis, data from one approval study each (SPRINT-2 and RESPOND-2) were available. With the available studies, it is not possible to assess directly whether the new active ingredient influences secondary diseases, such as the development of liver cancer. This is partly because the studies have not lasted long enough for these patient-relevant outcomes to be recorded.

With respect to SVR, there was a clear advantage for boceprevir, both for pretreated patients and for non-pretreated patients without liver cirrhosis. However, SVR is not itself a patient-relevant outcome and cannot be equated with "cure", 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 the 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 unclear how many cases of liver cancer can in fact be prevented by boceprevir.

For the outcome "secondary diseases", IQWiG recognizes an "indication" of a benefit for boceprevir. The requirements for a "proof" are not fulfilled, one reason being that the data are only derived from a single study each, with a comparatively small number of patients. Moreover, the scientific data do not permit a conclusive assessment of the number of patients in whom liver cancer is actually prevented. It is therefore unclear whether the added benefit is "minor", "considerable" or "major". For such a case, the corresponding legal ordinance specifies the assessment category of "unquantifiable".

Indication of greater harm for patients without prior treatment

The indication of greater benefit is in contrast to the indication of greater harm, but only in previously untreated patients. In these patients, boceprevir more often led to anaemia, although this was rarely serious. IQWiG classified the extent of this greater harm as "considerable". In contrast, in patients with prior treatment, anaemia was no more frequent than with standard treatment.

Effect on mortality unclear

IQWiG established that the approval studies contained inadequate data on quality of life for patients with or without prior treatment. There were no statistically significant differences in mortality between the treatment groups. It thus remains unclear if and how boceprevir influences mortality.

Contact: Anna-Sabine Ernst
Institute for Quality and Efficiency in Health Care

Related medicine news :

1. Prasugrel: Indications of an additional benefit for some patients, but also of greater harm
2. Sanofi Pasteur announces FDA approval of menactra meningococcal conjugate vaccine indication for infants
3. Indications of Alzheimers disease may be evident decades before first signs of cognitive impairment
4. Early indications of Parkinsons disease revealed in dream sleep
5. Calorie count plus points based on added sugars, sodium, and saturated and trans fats recommended as new front-of-package nutrition labeling system
6. Ticagrelor: Considerable added benefit for specific patients
7. Hospitals encouraged to consider value-added service of hospital-based radiology groups
8. Pelvic Mesh for Incontinence May Carry Added Risk for Women: FDA
9. Phase 3 trial finds no benefit from atrasentan added to chemo for advanced prostate cancer
10. Newer Versions of the Pill Pose No Added Risk to Gallbladder
11. More Added Sugars, More Pounds?
Post Your Comments:
(Date:10/13/2017)... ... October 13, 2017 , ... While it’s often important to ... Fortunately, an inventor from Austin, Texas, has identified a solution. , She developed a ... or restricted lighting. As such, it eliminates the need to turn on a light ...
(Date:10/13/2017)... QUEENS, N.Y (PRWEB) , ... October 13, 2017 , ... ... recently became a member of ElderCounsel, a national organization of elder law and special ... constantly changing laws and rules. It also provides a forum to network with elder ...
(Date:10/13/2017)... NJ (PRWEB) , ... October 13, 2017 , ... Global ... at scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global ... physical activity. The fun run is geared towards children of all ages; it ...
(Date:10/13/2017)... ... 13, 2017 , ... “America On The Brink”: the Christian history of the ... is the creation of published author, William Nowers. Captain Nowers and his wife, ... he spent thirty years in the Navy. Following his career as a naval ...
(Date:10/12/2017)... ... 12, 2017 , ... IsoComforter, Inc. ( ), one of ... innovative new design of the shoulder pad. The shoulder pad provides optimal support ... your pain while using cold therapy. By utilizing ice and water that is circulated ...
Breaking Medicine News(10 mins):
(Date:9/18/2017)... Sept. 18, 2017 EpiVax, Inc. ... bioinformatics and immune engineering, today announced a ... A (H7N9) vaccine. ... seasonal influenza and presents a challenge for ... exposure to be effective. Using state-of-the-art bioinformatics and ...
(Date:9/12/2017)... NEW YORK , Sept. 12, 2017   EcoVadis , ... supply chains, has published the first annual edition of its Global CSR ... than 20,400 companies evaluated by EcoVadis, based on Scorecard Ratings that analyzed ... ... & Performance Index ...
(Date:9/12/2017)... 12, 2017  ValGenesis Inc., the global leader ... pleased to announce the appointment of Dr. ... Board of Directors and Chairman of Advisory Board ... science companies to manage their entire validation lifecycle ... in this process. Furthermore, ValGenesis VLMS enables rigorous ...
Breaking Medicine Technology: