by Edouard Hubert

PARIS, Feb 27 (APM) - Gilead France president Michel Joly has underlined several advantages with the company’s treatment for chronic hepatitis C (HCV) Harvoni (sofosbuvir+ledipasvir) in comparison with the new arrival on the market, AbbVie's combination of Viekirax (ombitasvir+paritaprevir+ritonavir) plus Exviera (dasabuvir), in an interview with APM.

Speaking on Thursday, Joly acknowledged AbbVie’s multi-therapy is a “good product in terms of development, with good efficacy rates,” but claimed that Harvoni is “easier to use” since it involves one tablet a day compared with three for its competitor.

He claimed that a “large part of treatments” with Harvoni should last eight weeks, compared with 12 for Viekirax/Exviera.

Harvoni was approved in Europe in November (APMMA 40487), followed two months later by Viekirax+Exviera (APMMA 41118). The two drugs each have a group temporary authorisation (ATU de cohorte) in France, but whereas Harvoni costs 48,000 euros for a 12-week course (32,000 euros for eight weeks), AbbVie decided to offer its multi-therapy free of charge until mid-March (APMMA 41343).

Joly pointed out that, according to the fifth expert opinion of the French association for the study of liver diseases (AFEF) - that inventories 37 treatment regimens that do not require pegylated interferon - “in many settings you can use Harvoni or Viekirax/Exviera.

However, where they are interchangeable, in 70% of cases AbbVie’s multi-therapy needs to be combined with ribavirin compared with just 5% to 10% of cases for Harvoni”.

Finally, he pointed out that whereas Harvoni has no contra-indication, the presence of the ritonavir “booster”, a cytochrome P450 inhibitor, in Viekirax means it cannot be used concomitantly with a number of other drugs.

Harvoni's predecessor, Sovaldi (sofosbuvir), has been approved in Europe since January 2014 and has been reimbursed in France since November after having been available under a group temporary authorisation (ATU de cohorte). Joly said 14,000 patients were treated in 2014 with Sovaldi, of whom “90% had liver fibrosis stage F3 or F4”.

“In the first part of 2014, Sovaldi was used in combination with pegylated interferon, then, following the temporary authorisations (ATUs) for simeprevir (Janssen’s Olysio) and daclatasvir (Bristol-Myers Squibb’s Daklinza) around summer, interferon disappeared,” he said, noting that for the “most seriously ill patients,” the sofosbuvir+daclatasvir combination was the most used in long treatment durations (24 weeks).

The challenge for Sovaldi and its successor is now to “open up the market to patients presenting with liver fibrosis stage F2 (“severe F2,” according to the Sovaldi reimbursement decree). The more time passes, the more we shall treat stage F2 patients,” Joly said.

So far, Sovaldi is reimbursable in this population, but this is not yet the case for Harvoni, daclatasvir, simeprevir and the AbbVie multi-therapy, for which the group temporary authorisations are limited to F3-F4 patients.

Joly is “confident” oral combinations shall be reimbursed for F2 patients “some time between now and summer”. For Harvoni - currently before France's Transparency Commission (CT) - he says he is aiming for a reimbursement price equal to that of the ATU.

“According to studies by the French national authority for health (HAS) and by the French National Agency for AIDS and Hepatitis Research (ANRS), Harvoni is cost-effective up to 60,000 euros for stage F2 patients,” he said.

Sovaldi was priced at 56,000 euros when it was under ATU for a 12-week course. Joly said this price had been set for a specific indication of the drug: following liver transplant with recurrence of HCV infection, namely, among the most serious cases.

“Perhaps we should have changed it” in view of the set of indications specified in the ATU, he acknowledged.

The discount level for Sovaldi in France has been revealed to be around 46% overall, according to Gilead representatives.

Joly referred to the words of a member of the French economic committee for health (CEPS) who, in November, said the discount was “highly substantial” (APMMA 40634).

However, he did specify that turnover of Sovaldi and Harvoni is essentially made 85% to 90% in the U.S. and that it is therefore the discounts granted to U.S. payers that weigh most in the figure put forward by the group’s leaders.

In France, “the price per course is difficult to calculate,” he pointed out, as it is necessary to take into account the discounts granted in respect of the price difference between the ATU and the reimbursement, contractual rebates, and the tax (retroactive for 2014) voted in the social security funding law (LFSS) for 2015.

“Once prices have stabilised sometime in 2015, I would like it if state health insurance would publish the actual cost of a hepatitis C treatment,” he said.

eh/aki/hlc