Pharmaceutical News
Registration platform for the access to hepatitis C new drugs to start before February

Reported by Tsai Ming-Hua from Taipei


This year, the NHIA is going to reimburse two new oral drugs for hepatitis C.  The NHIA expects the quota of 8000 patients will be filled in just six months.  The NHIA will activate the registration platform for the new treatment around February so that patients in need of the treatment can apply for it.


Unfortunately, there was a mortality case of liver toxicity associated with the use of one of the new oral drugs.  Health experts remind the patients that neither of the two new oral drugs available under the NHI is suitable for patients with severe cirrhosis.  Physicians must prescribe the drugs with extra care. 


Chi Ro-Feng, a specialist of the TFDA, stated that an ADR case concerning the use of a new oral drug for hepatitis C was reported to the TFDA yesterday.  She confirmed that a hepatitis C patient has died from liver toxicity associated with the use of a new oral drug which the patient paid privately.  Liver toxicity is one of the side effects stated on the package insert.  Though liver toxicity is not unexpected, whether it is fatal depends on the assessment of the liver function prior to the treatment.  Patients should stop the treatment immediately after the development of any adverse reaction.


Pu Ro-Fang, the Director of the National Office for Hepatitis C Treatment Program, pointed out that this mortality case is a patient with severe cirrhosis.  The NHIA has decided that the NHI-funded new oral drugs will not be available to patients with severe cirrhosis.


The two new drugs available under the NHI are: Daklinza/ Sunvepra (from BMS) and Exviera +Viekirax (from AbbVie).


Shih Ru-Liang, a Section Chief of the NHIA, added that patients who are qualified for the NHI-funded treatments will receive just two-week doses initially.  After the initial doses, it is essential for the patients to visit their doctors for a follow-up assessment of their liver function and the treatment effectiveness in order to secure their further treatments.


【2016-01-09/ Apple Daily】