Trend Watch

ACH-3102/Sofosbuvir Yields High SVR Rates in Patients with HCV

In an ongoing, phase 2 clinical trial, 100% of patients with hepatitis C virus genotype 1 infection achieved a sustained virologic response after 6 weeks when treated with a combination regimen of ACH-3102, a NS5A inhibitor, and sofosbuvir, according to a press release from the drug maker.

“The profile of ACH-3102 represents an important and exciting treatment option to shorten treatment duration for patients infected with HCV,” investigator Edward Gane, MD, and deputy director and hepatologist at the New Zealand Liver Transplant Unit of Auckland City Hospital in New Zealand, said in the release.

Twelve treatment-naive patients received 50 mg of ACH-3102 (Achillion Pharmaceuticals) and 400 mg of sofosbuvir (Sovaldi, Gilead Sciences) once a day for 8 weeks. The cohort included six additional observational patients, according to the release. Once that cohort completed the 8 weeks, another cohort of 12 patients (six observational) underwent a 6-week treatment regimen with the same dosages. Twelve weeks after treatment was completed, all patients in the 6-week treatment arm achieved a sustained virologic response (SVR) and 100% of patients in the 8-week treatment arm achieved SVR 24 weeks after treatment ended, according to the release.

The treatment regimen was well tolerated and no serious adverse events or discontinuation of treatment occur during the trial, according to the release.

“The achievement of 100% SVR12 after 6 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,” David Apelian, MD, executive vice president of clinical development and chief medical officer at Achillion, said in the release. “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-naive genotype 1 HCV patients.”

The FDA granted Achillion Fast Track Designation for ACH-3102 to treat HCV genotype 1 in May 2012.

Disclosure: Gane reports financial relationships with AbbVie, Boehringer Ingelheim, Gilead, Janssen, Novartis, Roche and Tibotec.

In an ongoing, phase 2 clinical trial, 100% of patients with hepatitis C virus genotype 1 infection achieved a sustained virologic response after 6 weeks when treated with a combination regimen of ACH-3102, a NS5A inhibitor, and sofosbuvir, according to a press release from the drug maker.

“The profile of ACH-3102 represents an important and exciting treatment option to shorten treatment duration for patients infected with HCV,” investigator Edward Gane, MD, and deputy director and hepatologist at the New Zealand Liver Transplant Unit of Auckland City Hospital in New Zealand, said in the release.

Twelve treatment-naive patients received 50 mg of ACH-3102 (Achillion Pharmaceuticals) and 400 mg of sofosbuvir (Sovaldi, Gilead Sciences) once a day for 8 weeks. The cohort included six additional observational patients, according to the release. Once that cohort completed the 8 weeks, another cohort of 12 patients (six observational) underwent a 6-week treatment regimen with the same dosages. Twelve weeks after treatment was completed, all patients in the 6-week treatment arm achieved a sustained virologic response (SVR) and 100% of patients in the 8-week treatment arm achieved SVR 24 weeks after treatment ended, according to the release.

The treatment regimen was well tolerated and no serious adverse events or discontinuation of treatment occur during the trial, according to the release.

“The achievement of 100% SVR12 after 6 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,” David Apelian, MD, executive vice president of clinical development and chief medical officer at Achillion, said in the release. “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-naive genotype 1 HCV patients.”

The FDA granted Achillion Fast Track Designation for ACH-3102 to treat HCV genotype 1 in May 2012.

Disclosure: Gane reports financial relationships with AbbVie, Boehringer Ingelheim, Gilead, Janssen, Novartis, Roche and Tibotec.