Gilead once-daily hep C drug approved in Europe
The European Commission (EC) has granted marketing authorisation (MA) for Gilead Sciences' Harvoni (ledipasvir/sofosbuvir), the first once-daily single tablet regimen to treat most chronic hepatitis C genotype 1 (GT1) and 4 infection in adults.
Harvoni combines the NS5A inhibitor ledipasvir (LDV) with the nucleotide analogue polymerase inhibitor sofosbuvir (SOF), known as Sovaldi, approved by the EC in January 2014.
Harvoni is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and is recommended in treatment-naïve and treatment-experienced cirrhotic and non-cirrhotic GT1 and 4 patients. It is also indicated for patients with HCV who have human immunodeficiency virus (HIV) co-infection.
GlobalData analyst Dr Christopher Pace expects Harvoni to quickly usurp other Sovaldi-based regimens as the preferred treatment option for GT1 patients owing to its stellar clinical profile and reduced pill burden relative to approved and off-label options.
Furthermore, by attributing the bulk of Harvoni's wholesale acquisition cost (WAC) to Sovaldi, Gilead will also discourage the off-label use of more expensive Sovaldi-based, direct-acting antiviral regimens, strengthening its position against competitors Bristol-Myers Squibb, Johnson & Johnson, AbbVie and Merck.
Pace commented: "Gilead's shrewd pricing strategy for the fixed-dose combination pill, with an anticipated WAC of $94,500 for a 12-week course, will help to facilitate its rapid uptake, particularly in the US.
"This approach will easily position Harvoni as the more cost-effective option for most GT1 patients, compared with the interferon-sparing Sovaldi regimens, which have an estimated WAC of $94,726 for a 12-week course of Sovaldi combined with Pegasys [peginterferon alfa-2a] and ribavirin. This pricing strategy will be especially effective for patients who can be cured with an eight-week course of Harvoni, which carries an expected WAC of $63,000."
However, he noted that while Gilead had a clear lead over competitors in the US, its position in other major markets was less tenable: "Compared to the US, Gilead has faced a delayed uptake of Sovaldi-based regimens in the five European countries of Germany, Italy, Spain, France and the UK due to cost-effectiveness concerns, particularly in the latter two countries."
The MA follows an accelerated assessment by the European Medicines Agency (EMA) based mainly on the phase III trials ION-1, ION-2 and ION-3, evaluating Harvoni, with or without ribavirin, among nearly 2,000 GT-1 HCV patients with compensated liver disease.
"Genotype 1 patients living with hepatitis C in Europe and the physicians who treat them have been waiting for a treatment advance like this for decades," said Dr Graham Foster, Professor of Hepatology, Queen Mary University of London. "With Harvoni, we have the potential to transform the way we treat people living with the most prevalent form of hepatitis C in Europe. We can now expect very high SVR [sustained virologic response] rates, and for many patients, we can eliminate the need for interferon injections and ribavirin and offer a cure in a once-daily tablet."
The approval was also supported by preliminary data from the SOLAR-1 trial, which evaluated difficult to treat patients with decompensated cirrhosis and patients who had undergone liver transplantation, and from the ERADICATE trial, which evaluated GT-1 HCV patients co-infected with HIV.
Harvoni was approved in the US and Canada in October and in New Zealand earlier this month. Regulatory submissions are pending in Japan and Switzerland. The EC MA allows the marketing of the drug in all 28 countries of the European Union.
Sovaldi is approved for use as a single agent in the European Union, US, Canada, Australia, New Zealand, Egypt, Switzerland and Turkey.
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