The European AIDS Treatment Group (EATG – www.eatg.org) appreciates and praises the decision of Janssen to remove Incivo® (telaprevir) tablets for the treatment of hepatitis C infection from the pharmaceutical market of the European Union. With the availability of safer and more effective choices of medicine in the hepatitis C field, first generation medicines such as telaprevir with their burden of side effects do not offer any added benefit and should not be used anymore. The EATG has been advocating for the availability of all medicines that may help even the smallest patient populations to recover their health and attain a cure from viral hepatitis. But when new, better medicines become available, older, less effective or less safe ones should be removed from the market.
After several years of joint work in clinical development and research, many hours of discussions and mutual coordination, the pharmaceutical company Janssen informed the EATG about their decision to not renew its license for Incivo® (telaprevir 375 mg) tablets with the European Medicines Agency, the company communicated on 26 August 2016.
With up to 170 million people living with hepatitis C worldwide, and with the immense improvement in treatment effectiveness and tolerability over earlier treatment regimes, the availability of reliable, affordable and safe treatment options is more important than ever. This is a particular priority for the communities of people living with HIV, as viral hepatitis remains one of the main reasons for illness and death in this population. However, the risks clearly outweigh the benefits of interferon-based treatment regimes, and telaprevir is prescribed as part of an interferon-based regime.
“All compounds that are useful, even for the smallest group of patients, should remain on the market. We have been advocating for the availability of safe and effective medicine, and we also want to make sure that single compounds and not only fixed-dose combination are available”, pointed out Luís Mendão, chair of the European AIDS Treatment Group and member of ECAB, the scientific working group of the EATG. “However, you must listen to the communities of patients and see when risks outweigh the benefits”, he continued.
As one of the leading patient organisations in the field of HIV/AIDS, the EATG remains in the forefront of interaction with researchers, regulators and pharmaceutical companies to ascertain that patients have access to the best possible treatment for HIV and viral hepatitis. The EATG is willing and ready to support other patient communities in the world who are working on similar efforts. We also continue to rely on good, trustful and equal partnerships and cooperation with all stakeholders as also demonstrated in this case.
Read and download the statement here: INCIVO_STATEMENT_final