February 9, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Achillion Pharmaceuticals, Inc. and Gilead Sciences, Inc. announced today that their combination of ACH-3102 and sofosbuvir for treatment-naïve genotype 1 HCV was able to treat 100 percent of patients over the course of six weeks. This news came after Achillion updated interim results from an ongoing interferon-free, ribavirin-free Phase II study.
“The ability to further shorten treatment duration to only six weeks and maintain excellent SVR12 rates remains the goal for clinicians and patients, and I am pleased that these Phase II results support that goal,” said Edward Gane, lead investigator of the Phase II study. “The profile of ACH-3102, represents an important and exciting treatment option to shorten treatment duration for patients infected with HCV.”
The primary objective of the study is to determine sustained viral response after 12 weeks of therapy, as well as the efficacy, safety and tolerability of the drugs at the six-week mark. Patients are given 50 mg of ACH-3102 and 400 mg of sofosbuvir.
“The achievement of 100 percent SVR12 after six weeks of treatment with a dual NS5A-nucleotide regimen, even in patients with high baseline viral load who would otherwise require extended duration treatments, supports our belief that ACH-3102 can unleash the potential of this combination to drive down treatment duration,” said David Apelian, executive vice president of clinical development and chief medical officer at Achillion. “We are currently preparing to initiate our SPARTA Phase 2 program which evaluates short treatment durations with our proprietary once-daily regimens of ACH-3102 and ACH-3422, with or without sovaprevir, for treatment naïve genotype 1 HCV patients.”
A Closer Look at ACH-3102
ACH-3102 is an investigational compound founded by Achillion back in 2011. It is a structurally distinct second-generation NS5A inhibitor, and it has been granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of hepatitis C.
In November 2014, Achillion presented results from the ongoing Phase II study that looked at ACH-3102 and sofosbuvir as a treatment for hepatitis C. This data encouraged further research that led to the results presented today.
“The antiviral activity and safety profile observed to date for ACH-3422 both in preclinical studies and in the ongoing 422-001 Phase 1 trial support further development with this nucleotide in combination with Achillion‘s other direct-acting antivirals, and represents an exciting treatment option for HCV,” Gane stated, at the time of the announcement.
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