You are here
Drug Combination Knocks Out HCV in Six Weeks During Phase II Trial
Promising results from a small phase II trial raise the possibility of hepatitis C virus treatments lasting as little as six or even four weeks.
All 12 patients in a six-week treatment duration arm achieved a sustained viral response 12 weeks after completion of therapy (SVR12) after receiving a combination of the investigational drug ACH-3102 and sofosbuvir (Sovaldi, Gilead Sciences). This included patients with a high baseline viral load, according to Achillion Pharmaceuticals, Inc., which is developing ACH-3102.
Achillion announced updated interim results from the ongoing interferon-free, ribavirin-free study to evaluate the efficacy, safety, and tolerability of six weeks of 50 mg of ACH-3102 and 400 mg of sofosbuvir in treatment-naïve genotype 1 HCV-infected 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,” said Dr. Milind Deshpande, President and Chief Executive Officer of Achillion.
The ongoing study is an open-label, randomized, partial-crossover trial to evaluate the efficacy, safety, and tolerability of eight and six weeks of ACH-3102, an NS5A inhibitor, and sofosbuvir, a nucleotide polymerase inhibitor, once daily in treatment-naïve genotype 1 HCV-infected patients. Initially, 18 patients were enrolled, including six observational patients, into an eight-week treatment cohort.
Following the achievement of 100% SVR12 (12 of 12 patients) in the eight-week cohort, the six-week treatment cohort was initiated. Eighteen patients were enrolled, including 12 active and six observational patients. Mean baseline HCV RNA viral load was 10 million (7 log10) IU/mL (range, 2 million [6.23 log10] to 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.
All 12 active patients achieved SVR12, independent of baseline viral load, gender, and IL28B status, in the six-week treatment arm. Additionally, all 12 patients 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 electrocardiogram abnormalities.
Achillion is preparing to initiate its SPARTA phase II program to evaluate short treatment durations with its once-daily regimens of ACH-3102 and ACH-3422, a nucleotide NS5B polymerase inhibitor, with or without sovaprevir, an NS3/4A protease inhibitor, for treatment-naïve genotype 1 HCV patients. The company will also explore sofosbuvir-sparing regimens that will leverage shorter durations of sofosbuvir in combination with ACH-3102 and sovaprevir.
Source: Achillion Pharmaceuticals, Inc.; February 9, 2015.