Gilead's Harvoni Achieves 96% Cure Rate in Patients With Hepatitis C and HIV

February 27, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Gilead Sciences, Inc. has more good news about hepatitis C “miracle drug” Harvoni, saying Friday that a recent Phase III study found that the drug has a 96 percent cure rate for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV.

GIlead said that in the recent trial, 96 percent of HCV patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12), a clinical benchmark uses to determine whether or not a patient is still infected. Gilead announced the findings at the 22nd Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

“This trial provides strong evidence that people who are co-infected with HIV can achieve very high rates of hepatitis C cure with a combination direct-acting antiviral regimen,” said Susanna Naggie, director of infectious diseases research at Duke Clinical Research Institute and principal investigator for the ION-4 study. “These high cure rates were observed in most of the historically difficult-to-treat sub-populations, including those who failed previous treatment and those with cirrhosis. We are greatly encouraged by these findings.”

The U.S. Food and Drug Administration (FDA) has already approved the first once-a-day pill for the treatment of hepatitis C. Harvoni is a cocktail of ledipasvir and sofosbuvir (known under the brand name Sovaldi), has been cleared for use in the main subtype of hepatitis, called genotype 1, which accounts for more than two-thirds of the nation’s cases.

Gilead has had high hopes for Harvoni, after clinical trials found that over 90 percent of the patients treated with the drug had no detectable virus in their blood three months after treatment was ended. In medical parlance, that is effectively a cure.

“By providing very high cure rates in as little as eight weeks and completely eliminating the need for interferon and ribavirin, which are challenging to take and tolerate, Harvoni significantly advances treatment for patients with the most common form of hepatitis C in the United States,” said Nezam Afdhal, director of hepatology at Beth Israel Deaconess Medical Center, professor of medicine at Harvard Medical School and a principal investigator in the Harvoni clinical trials, in a statement.

“For the first time, the vast majority of patients can be cured with a once-daily pill in only eight or 12 weeks,” said Afdhal.

Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the tradename Sovaldi in December 2013. Harvoni’s efficacy has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load.

Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.

The high costs of both drugs remain controversial, however. A 12-week course of Harvoni costs around $94,500, while a similar course of Sovaldi will run as much s $84,000. Those price tags have had insurers and public health plans like Medicaid and Express Scripts Inc. balking at backing the treatment or offering reimbursement.

Gilead has consistently told news outlets that its pricing is reasonable, but it has been forced to drop the price for its hepatitis C drug Sovaldi, most recently in mid-February when it has to discount the drug for German regulators to $46,625 for a 12-week course of the drug, an almost fire sale drop from its regular cost of $84,000 per course.

The GKV association of Germany's statutory medical insurers, who provide coverage for 90 percent of Germans, said Friday that is has managed to talk Gilead into lowering the price of Sovaldi to 43,562.52 euros. Then that price tag is subject to a further 5.88 percent discount for other statutory insurers, leaving Gilead and its shareholders increasingly frustrated by the brutal pricing war surrounding its hepatitis C therapies.

Sovaldi sells for approximately $1,000 per pill, while its sister medication, also from Gilead, Harvoni, sold about $2.1 billion in 2014. Similar competitor AbbVie 's HCV medication Humira recorded $12.5 billion in sales and is now gaining on the coattails of AbbVie’s new hepatitis C treatment, Viekira Pak.

The news is not entirely unexpected, Gilead has had to offer discounts in the American market as well, a fact it lamented to Citgroup analysts Feb. 12, said head biotech analyst Yaron Werber in a note to investors.

“Gilead believes that they had to provide higher rebates to get access to the public segments as state Medicaid programs have more restrictions than private plans. AbbVie was very aggressive on pricing and so the landscape weakened considerably faster than anticipated due to exclusivity contracts,” wrote Werber.

“Gilead expects volume to ramp up but it is not clear how fast in the public system. The 46 percent gross/net adjustment assumes a certain level of use in the public system and could be lower if the volume is slower to materialize,” he said. “The prison system is expected to kick into gear in 2016. In general rebates for Sovaldi are much lower than Harvoni.”

Gilead has been continuing its charm offensive, in mid-February sending Chief Operating Officer John Milligan and Vice President of Investor Relations Patrick O’Brien to lunch with analysts at Citigroup, who came away upbeat about the controversial firm’s business structure and convinced it will soon be attempting more mergers and acquisitions.

“We came out bullish that Sovaldi/Harvoni's volume will increase in U.S. and Europe in 2015 driven by increased rebates to public segments. Gilead's pipeline is also advancing and Simtuzumab should have interim 48 week data in late 2015 in NASH,” wrote Werber.

Despite telling the BIO CEO and Investor Forum Feb. 10 that Gilead “feels no urgency for mergers/acquisitions, but if we did, it would be thoughtful and reflective," Milligan’s time with Citi left analysts feeling the company is hungry for new deals, particularly in oncology.

“We detect that management is definitely gearing up the company to be very active on M&A in 2015 and oncology will likely be a key focus,” wrote Werber. “We do not anticipate one sizable deal that will have an imminent change but instead see a few smaller deals to bolster the pipeline for the mid-term.” Gilead’s team also remains convinced profits will stay high, just months after Gilead Sciences, Inc. (GILD) sold $10.3 billion of its new hepatitis C drug Sovaldi in 2014.

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