- Achillion achieves 100% SVR12 in six-week regimen
with combination of ACH-3102 and sofosbuvir for treatment-naïve
genotype 1 HCV -
- Achillion to initiate 4-week treatment regimens based on the strength of ACH-3102 antiviral data -
NEW HAVEN, Conn., Feb. 9, 2015 (GLOBE NEWSWIRE) --Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today announced updated interim results from the ongoing
interferon-free, ribavirin-free, Phase 2 study to evaluate the efficacy,
safety, and tolerability of six weeks of 50 mg of ACH-3102 and 400 mg
of sofosbuvir, a marketed nucleotide polymerase inhibitor, in
treatment-naïve genotype 1 HCV-infected patients. The primary objective
of the study is determination of sustained viral response 12 weeks
(SVR12) after completion of therapy. One hundred percent of patients
(12/12) in the six-week treatment duration arm achieved SVR12, which
included patients with high baseline viral load.
"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 2 results support that goal.
The profile of ACH-3102, represents an important and exciting treatment
option to shorten treatment duration for patients infected with HCV,"
commented Professor Edward Gane, M.D., Deputy Director and Hepatologist,
New Zealand Liver Transplant Unit, Auckland City Hospital in New
Zealand, and Lead Investigator in the Phase 2 study of ACH-3102 and
sofosbuvir and the ACH-3422 nucleotide inhibitor program.
Dr. Milind Deshpande, President and Chief Executive Officer of
Achillion, commented, "Our goal is to deliver short duration, widely
accessible treatments to all HCV patients. We believe that these results
with ACH-3102 represent the shortest duration and highest response
achieved to date with any two-drug, direct-acting antiviral regimen for
HCV. Given the exceptional profile of ACH-3102, we will now be
evaluating four- and six-week treatment durations that leverage all of
our HCV assets including ACH-3102, ACH-3422, and sovaprevir."
Overview of Phase 2 Proxy Study Design and Top-line Results
This ongoing study is a Phase 2 open-label, randomized,
partial-crossover study to evaluate the efficacy, safety, and
tolerability of eight- and six weeks of 50 mg of ACH-3102 and 400 mg of
sofosbuvir, a marketed nucleotide polymerase inhibitor, once daily, in
treatment-naïve genotype 1 HCV-infected patients. Initially, eighteen
patients were enrolled, including six observational patients, into an
eight-week treatment cohort.
Following the achievement of 100 percent SVR12 (12/12) in the
eight-week cohort, the six-week treatment cohort was initiated. In all,
eighteen patients were enrolled, including twelve active and six
observational patients. Mean baseline HCV RNA viral load was 10 million
(7 log10) IU/ml, range 2 million (6.23 log10) - 97 million (7.99 log10) IU/ml, including seven patients with baseline HCV RNA viral load exceeding 6 million (6.78 log10) IU/ml. Of the 12 active patients enrolled, seven patients were genotype 1a and five were genotype 1b.
Twelve weeks after the completion of therapy, 100 percent (12/12)
achieved SVR12, independent of baseline viral load, gender, and IL28B
status, in the six-week treatment arm. Additionally, one hundred percent
of patients (12/12) in the eight-week treatment duration arm have
achieved SVR24. The combination of ACH-3102 and sofosbuvir was
well-tolerated with no serious adverse events, no discontinuations due
to adverse events, and no clinically significant laboratory or ECG
"The achievement of 100% 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," commented Dr. 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. In parallel, we
plan on exploring sofosbuvir-sparing regimens that will leverage
shorter durations of sofosbuvir in combination with ACH-3102 and
sovaprevir as part of our global development program."
Read complete press release here...
Labels: 6 week treatment, ACH-3102 plus sofosbuvir, achillion