Zepatier Tops Other Hepatitis C Drugs in Safety Comparison

A recent analysis found that Merck’s Zepatier beats out Gilead’s Harvoni and Sovaldi in clinical safety and cost for hepatitis C (HCV) patients, according to Advera Health Analytics.

Elbasvir and grazoprevir (Zepatier) was approved by the FDA on January 28, 2016, for patients who suffer from chronic hepatitis genotype 1 and 4. It is listed at $54,600 for a 12-week treatment regimen, compared with $94,600 for Harvoni and $83,319 for Viekira Pak.

“Half cost of Zepatier has alarmed the competitors, especially Harvoni,” wrote Raheel Farooq in Business Finance News. “The Zepatier less price factor is likely to give an edge to acquire overall state and some commercial payers. There is a big chance of price war between the companies. Zepatier’s launch can reduce Harvoni’s sale to $12.24 billion in 2016, approximately 12% as compared to 2015.”

The analysis reported that Sovaldi had the highest amount of serious side effects out of the 3 drugs, such as cardiac arrest and suicidal thoughts. Zepatier has not been found to carry the same side effects as Sovaldi, but is instead comparable to Harvoni.

In fact, Advera suggests the FDA should require other serious side effects be added to Sovaldi’s label, such as progressive multifocal leukoencephalopathy, Stevens-Johnson syndrome, and drug-induced liver injury.

“The general conclusion is that Zepatier looks safer than Sovaldi, just based on clinical trial information,” Advera Chief Product Officer Bob Kyle said in a report on FiercePharma. “(But) anything can change once the real world data starts to come through. It’s something to keep an eye on in post-marketing data.”

Interferon was previously used for HCV patients, but it came with unbearable side effects. Sovaldi was launched in 2013 with lesser side effects compared with interferon. Sovaldi proved to have cure rates up to 90% with just 12 to 24 week treatment durations, as opposed to interferon regimens of 24 to 48 weeks.

With the launch of Harvoni in October 2014 with an 8 to 12 week treatment regimen, it eliminated the use of interferon. Harvoni also became the fastest selling drug post development. Combined, Sovaldi and Harvoni reached sale revenues of $12.5 billion (2014) and $14 billion (first 9 months of 2015) since launch.

Although Zepatier performed almost equally as well treating patients in clinical trials, Harvoni was found to perform better compared with Zepatier and Sovaldi in previously treated HCV patients.

AbbVie’s interferon-free Viekira Pak also added to the crowded HCV treatment market. It is used without ribavirin for HCV genotype 1 and 4 patients. In 2015, it was reported that Viekira Pak revenues were $227 million within the United States and $158 million internationally.

"Our clinical development program for Zepatier is among the largest and most comprehensive for chronic HCV treatment,” Merck spokeswoman Sarra Herzog told FiercePharma. “It included studies dedicated to patient populations where significant unmet medical need still exists, such as prior treatment failures, as well as those living with co-morbid conditions, including HIV infection and advanced chronic kidney disease. We believe our clinical data and FDA-approved prescribing information demonstrate the value of Zepatier."