MILAN, Oct 28 (APM) - Italy has launched a pre-authorisation programme for treatment with AbbVie’s hepatitis C therapy, ABT-450/ritonvavir+ombitasvir+dasabuvir, widening use of the rival to Gilead's Sovaldi (sofosbuvir) - which is already available for a limited number of patients.
AIFA has drawn up a list of patients who will be eligible under the scheme and according to a Monday statement from the regulator, it initially will be used to treat only genotype 1 HCV patients, who are intolerant to interferon, in four categories.
Patients eligible for the ribavirin-free regimen are:
:: those who have relapsed after a liver transplant (fibrosing cholestatic hepatitis or chronic hepatitis with a Metavir fibrosis score of F0-2);
:: those with compensated cirrhosis (Child-Turcotte-Pugh score A) without other significant diseases;
:: those with chronic hepatitis with fibrosis Metavir score of F3 who have not responded to double therapy (peginterferon + ribaravin);
:: those with chronic hepatitis with clinically significant HCV-related issues (eg. moderate to sever symptomatic cryoglobulinemia or lymphoproliferative disorder).
AIFA provided a list of specialists centres where treatment programmes have already been approved by ethics committees for named patient compassionate use of the triple therapy, or as a part of the company’s clinical studies. These centres will be contacted by the company’s medical officers to be instructed how to start a treatment programme with the aim of accelerating the process, the regulator added.
AIFA noted that AbbVie already provides the hepatitis C therapy in Italy in a named-patient compassionate use programme, authorisation of which will now cover the special treatment programme as well.
The combination, which comprises AbbVie's protease inhibitor ABT-450 (paritaprevir), nonnucleoside polymerase inhibitor dasabuvir (ABT-333) and NS5A inhibitor, ombitasvir, is undergoing accelerated assessment by the European Medicines Agency (APMMA 38757).
The Italian agency said the initiative will further expand access to new hepatitis C treatments which still have not been registered in Italy. Gilead has been running a compassionate use programme to provide Sovaldi (sofosbuvir) hepatitis C patients in Italy with the most urgent need of treatment since July. (APMMA 39036)
The drug has been approved for reimbursement and will be available on the national health service for certain categories of patients once the authorisation and the price have been published in the official statutes record, probably sometime in November.
Bristol-Myers Squibb is negotiating with AIFA to fast track access to its hepatitis C drug Daklinza (daclatasvir) in a special programme for Italian patients. (APMMA 39905)
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