FDA Granted Breakthrough Therapy Status to Merck’s HCV Therapy


Nov. 20 2020, Updated 12:00 p.m. ET

Breakthrough therapy designation

The U.S. Food and Drug Administration (or FDA) granted breakthrough therapy designation to Merck’s (MRK) grazoprevir/elbasvir (100mg/50mg) combination therapy, as it has demonstrated its efficacy in mid-stage clinical trials related to hepatitis C (or HCV) genotype one patients with end-stage kidney disease as well as patients suffering from chronic genotype four HCV.

The FDA’s decision regarding grazoprevir/elbasvir combination therapy is partly based on the results obtained from the phase 3 C-EDGE clinical trials program and phase 2 C-SURFER and C-SALVAGE clinical programs. Through these trials, Merck has evaluated the efficacy of the new therapy with and without ribavirin across HCV genotype one, four, and six patients including those who have already received any other HCV therapy or suffer from additional diseases such as liver cirrhosis, HIV, or kidney diseases.

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Clinical trial results

The above table shows the sustained virologic response (or SVR) results from Merck’s ongoing C-EDGE clinical program. According to Medscape, “The goal of chronic hepatitis C treatment is to remove the virus to avoid progression of HCV-related disease. Sustained virologic response (SVR) is the most widely used efficacy endpoint in clinical studies of hepatitis C, and represents the eradication of HCV from the body.”

The table shows SVR response rates at the end of 12 weeks and 16 weeks and is categorized across patients who either receive only grazoprevir/elbasvir (100mg/50mg) therapy or in combination with ribavirin (or RBV). The tests have been performed on treatment naïve patients (or TN), treatment experienced (or TX) patients, and patients suffering from co-infections (or CO-INFXN). HCV patients were also segmented based on genotypes as well as by whether they suffered from cirrhosis.

It was observed that the therapy resulted in strong SVR of 95% in TN and Co-INFXN patients. For TX patients, the SVR reached up to 97%. Phase two clinical trials such as C-SURFER and C-SALVAGE have also demonstrated strong SVR response for the drug. Based on the strong clinical profile, if approved, Merck is expected to give tough competition to other HCV players such as AbbVie (ABBV), Bristol-Myers Squibb (BMY), and Gilead Sciences (GILD).

Investors can get exposure to grazoprevir/elbasvir combination therapy while reducing company-specific risks by investing in the Health Care Select Sector SPDR Fund (XLV). XLV invests 5.6% of its portfolio in Merck.


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