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Here’s What’s Has Happened in the HCV Space Lately

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Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver. Gilead Sciences Inc. GILD markets blockbuster HCV drugs, Sovaldi and Harvoni, while other well-known names in this market are AbbVie Inc.’s ABBV Viekira Pak, Bristol-Myers’ BMY Daklinza and Johnson & Johnson’s JNJ Olysio.

According to the Centers for Disease Control and Prevention (CDC), about 3.2 million people in the United States are living with chronic hepatitis C infection while many remain unaware of being infected. There are about 17,000 new hepatitis C cases each year in the United States, many of which go unreported.

Considering these numbers, it is not a surprise that quite a few pharma and biotech companies are working on bringing new, improved, shorter-duration HCV treatments to the market. The market is thus getting crowded and seeing increased pricing pressure.

A lot has happened in the HCV space of late.

In September 2017, Gilead Sciences’ Sovaldi received approval in China, as a component of a combination antiviral treatment regimen. It is the first Gilead HCV drug to be approved in China.


Meanwhile, Gilead’s single-tablet regimen (STR) of Sovaldi, velpatasvir and voxilaprevir, Vosevi received approval in the United States, EU and Canada in July/August. Vosevi became the first once-daily STR available as a salvage therapy for patients infected with HCV genotype 1–6 who have failed prior treatment with DAA regimens including NS5A inhibitors.

Gilead’s shares have outperformed the industry year to date. The stock has rallied 16.6% compared with the industry’s gain of 14.5% in the same time frame. The stock carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Meanwhile, AbbVie’s 8-week, pan-genotypic, ribavirin-free, once-daily HCV treatment, Mavyret/Maviret, gained approval in the United States, EU and Canada in the past couple of months. Mavyret, AbbVie’s next-generation HCV program, is a combination of glecaprevir, a potent protease inhibitor and pibrentasvir, a NS5A inhibitor. Maviret has the potential to rejuvenate growth in the HCV franchise. According to AbbVie, Mavyret may be used in up to 95% of HCV patients, depending on the stage of liver disease and prior treatment history.

Abbvie’s shares have outperformed the industry year to date. The stock has rallied 44% compared with the industry’s gain of 17.9% in the same time frame. The stock carries a Zacks Rank #3.

However, last week, pharmaceutical giant Merck MRK announced that it is discontinuing further development of two of its next-generation hepatitis C (HCV) programs — MK-3682B (grazoprevir/ruzasvir/ uprifosbuvir) and MK-3682C (ruzasvir/uprifosbuvir). The company made this decision based on review of available phase II efficacy data and a heavily crowded HCV market.

Merck’s shares have underperformed the industry year to date. The stock has gained 9.7% compared with the industry’s gain of 17.9% in the same time frame. The stock carries a Zacks Rank #3.

Besides Merck, another giant Johnson & Johnson also discontinued the development of its investigational HCV treatment regimen JNJ-4178, a combination of three direct acting antivirals: AL-335, odalasvir and simeprevir. The company took this decision considering that there are several highly effective therapies available for this indication.

Johnson & Johnson’s shares have underperformed the industry year to date. The stock has gained 15.6% compared with the industry’s gain of 17.9% in the same time frame. The stock carries a Zacks Rank #3.

It is believed that the discontinuation of Merck and J&J’s combination HCV regimens should act in favor of Gilead and AbbVie. Gilead and AbbVie should benefit from the lack of additional competition entering the market, at least in the near term. However, the companies will continue to face challenges in the form of declining patient volume and intense pricing pressure. The lack of additional entrants in the market should also slow down the rate of decline in sales.

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