AASLD: Merck hep C combo slashes virus levels
- Merck & Co presented results from three of the Phase 2 trials for MK-3682B, an oral triple combo for the treatment of chronic hepatitis C infection, at the American Association for the Study of Liver Diseases (AASLD) annual meeting this weekend in Boston.
- In C-CREST 1&2 Part B, an ongoing study, the rate of sustained virologic response 12 weeks after completing treatment (SVR12, considered a virologic cure) was 95% in patients with genotype 1 and 3 who were treated for eight weeks, 97-99% in patients with genotype 1, 2, or 3 who were treated for 12 weeks, and 96-100% in patients with genotype 2 or 3 who were treated for 16 weeks.
- In chronic hepatitis C patients who had failed other treatments, 100% in C-CREST 1&2 Part C treated for 16 weeks achieved SVR12 and in the another trial, the going C-SURGE study, 100% of patients treated for 16 weeks achieved SVR8.
Curative and near curative therapies have revolutionized the field of chronic hepatitis C, with patients reaching so-called virologic cure after weeks rather than years of treatment. Yet, current treatments are mostly curative in only genotypes 2 and 3. There are, however, still unmet needs for patients who are infected with other genotypes, and opportunities to develop shorter regimens.
MK-3682B, also known as MK3, is a triple combination that combines MK-3682, an HCV nucleotide analogue NS5B polymerase inhibitor; grazoprevir, a HCV NS3/4A protease inhibitor; and ruzasvir, an HCV NS5A inhibitor. The data at the Liver Meeting 2016 showed that Merck's triple combo MK-3682B was effective in genotypes 1, 2 and 3, which could give it an advantage over other treatments.
Another way that companies can grab hold of market share is by shortening the therapy times. MK-3682B's potential for an eight week treatment could improve patient adherence and therefore their outcome. This compares with 12 weeks as standard for Gilead's Sovaldi (sofosbuvir), Merck's fixed dose combo Zepatier (elbasvir and grazoprevir) and Gilead's combination Harvoni (ledipasvir and sofosbuvir).
"Across the chronic hepatitis C treatment landscape, incredible progress has been made in a remarkably short amount of time, but there remains a need for more options, particularly for patients who do not achieve sustained virologic response with treatment regimens available today," said Eliav Barr, SVP of global clinical development for infectious diseases and vaccines at Merck Research Laboratories in a statement.
"The strong findings observed following treatment with MK-3682B are an encouraging step towards Merck’s goal of developing and delivering a shorter-duration, pan-genotypic next-generation treatment regimen for more patients with chronic hepatitis C infection."
Jefferies analysts are describing response rates of mid- to high-nineties as 'the new normal', and Merck's combination as potentially pressuring Gilead's market share.
- Merck & Co Statement
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