Meeting News Coverage

Sofosbuvir/ledipasvir combination led to SVR12 in phase 3 trial

LONDON — Treatment-naive patients with hepatitis C virus infection treated with a fixed-dose combination of sofosbuvir and ledipasvir for 12 or 24 weeks achieved a sustained virologic response, according to research presented at the International Liver Congress.

According to data from a phase 3 ION-1 study, 865 patients were randomized to receive a combination of sofosbuvir at 400 mg and ledipasvir at 90 mg, with and without ribavirin (RBV), once a day in pill-form. The primary endpoint was sustained virologic response at 12 weeks (SVR12). There were 431 patients in the 12-week group and 434 in the 24-week group. Overall, 97% of patients achieved SVR12, with 16/865 not achieving. Four percent of 24-week patients (32/434) experienced a severe adverse event (AE). Common AE among patients included fatigue (23%), headache (25%) and nausea (12%).

Peck-Radosavljevic_mug

Markus Peck-Radosavljevic

“With cure rates well in excess of 90% with as little as eight weeks of treatment for some patients, these data represent a significant advance in the race to develop a new, all-oral treatment for Hepatitis C,” Markus Peck-Radosavljevic, MD, secretary-general of the European Association for the Study of the Liver and associate professor of medicine at the University of Vienna in Austria, said in a press release.

In three ION studies combined, 1,952 patients with hepatitis C infection (HCV) were treated with this regimen, with and without ribavirin, and 96.6% (1,886) achieved SVR12; 3.4% (66/1,952) failed to achieve SVR12; 1.9% (38) experienced virological failure; and 1.4% (28) were lost to follow-up. Fewer adverse events were seen in the patients treated with the RBV-free, fixed-dose combination compared with RBV-containing patients, according to the release.

“The results of the ION studies demonstrated highly satisfactory cure rates with a fixed dose combination of sofosbuvir/ledipasvir among patients with genotype-1 HCV infection without the use of either injectable interferon, which causes miserable flu-like symptoms, or ribavirin, an antiviral pill associated with a variety of troublesome side effects, including anemia and rash,” Peck-Radosavljevic said in the release. “As a result of this marked improvement in tolerability, many more people are likely to seek treatment with this ribavirin-free regimen, which involved just one pill once a day.”

For more information:

Mangia A. #O164: All Oral Fixed-Dose Combination Sofosbuvir/Ledipasvir with or without Ribavirin for 12 or 24 weeks in treatment-Naive Genotype 1 HCV-Infected Patients: the Phase 3 ION-1 Study. Presented at: The International Liver Congress 2014; April 9-13, London.

Disclosure:Relevant financial disclosures were not provided by researchers.

LONDON — Treatment-naive patients with hepatitis C virus infection treated with a fixed-dose combination of sofosbuvir and ledipasvir for 12 or 24 weeks achieved a sustained virologic response, according to research presented at the International Liver Congress.

According to data from a phase 3 ION-1 study, 865 patients were randomized to receive a combination of sofosbuvir at 400 mg and ledipasvir at 90 mg, with and without ribavirin (RBV), once a day in pill-form. The primary endpoint was sustained virologic response at 12 weeks (SVR12). There were 431 patients in the 12-week group and 434 in the 24-week group. Overall, 97% of patients achieved SVR12, with 16/865 not achieving. Four percent of 24-week patients (32/434) experienced a severe adverse event (AE). Common AE among patients included fatigue (23%), headache (25%) and nausea (12%).

Peck-Radosavljevic_mug

Markus Peck-Radosavljevic

“With cure rates well in excess of 90% with as little as eight weeks of treatment for some patients, these data represent a significant advance in the race to develop a new, all-oral treatment for Hepatitis C,” Markus Peck-Radosavljevic, MD, secretary-general of the European Association for the Study of the Liver and associate professor of medicine at the University of Vienna in Austria, said in a press release.

In three ION studies combined, 1,952 patients with hepatitis C infection (HCV) were treated with this regimen, with and without ribavirin, and 96.6% (1,886) achieved SVR12; 3.4% (66/1,952) failed to achieve SVR12; 1.9% (38) experienced virological failure; and 1.4% (28) were lost to follow-up. Fewer adverse events were seen in the patients treated with the RBV-free, fixed-dose combination compared with RBV-containing patients, according to the release.

“The results of the ION studies demonstrated highly satisfactory cure rates with a fixed dose combination of sofosbuvir/ledipasvir among patients with genotype-1 HCV infection without the use of either injectable interferon, which causes miserable flu-like symptoms, or ribavirin, an antiviral pill associated with a variety of troublesome side effects, including anemia and rash,” Peck-Radosavljevic said in the release. “As a result of this marked improvement in tolerability, many more people are likely to seek treatment with this ribavirin-free regimen, which involved just one pill once a day.”

For more information:

Mangia A. #O164: All Oral Fixed-Dose Combination Sofosbuvir/Ledipasvir with or without Ribavirin for 12 or 24 weeks in treatment-Naive Genotype 1 HCV-Infected Patients: the Phase 3 ION-1 Study. Presented at: The International Liver Congress 2014; April 9-13, London.

Disclosure:Relevant financial disclosures were not provided by researchers.

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