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Previously treated HCV genotype 1 infection: efficacy of Ledipasvir and Sofosbuvir as fixed-dose combination


Effective treatment for hepatitis C virus ( HCV ) genotype 1 infection in patients who have not had a sustained virologic response to prior Interferon-based therapy represents an unmet medical need.

Researchers have conducted a phase 3, randomized, open-label study involving patients infected with HCV genotype 1 who had not had a sustained virologic response after treatment with Peginterferon and Ribavirin, with or without a protease inhibitor.

Patients were randomly assigned to receive the NS5A inhibitor Ledipasvir and the nucleotide polymerase inhibitor Sofosbuvir in a once-daily, fixed-dose combination tablet for 12 weeks, Ledipasvir - Sofosbuvir plus Ribavirin for 12 weeks, Ledipasvir - Sofosbuvir for 24 weeks, or Ledipasvir - Sofosbuvir plus Ribavirin for 24 weeks.

The primary end point was a sustained virologic response at 12 weeks after the end of therapy.

Among the 440 patients who underwent randomization and were treated, 20% had cirrhosis and 79% had HCV genotype 1a infection.

The rates of sustained virologic response were high in all treatment groups: 94% ( 95% confidence interval [CI], 87 to 97 ) in the group that received 12 weeks of Ledipasvir - Sofosbuvir; 96% ( 95% CI, 91 to 99 ) in the group that received 12 weeks of Ledipasvir - Sofosbuvir and Ribavirin; 99% ( 95% CI, 95 to 100 ) in the group that received 24 weeks of Ledipasvir - Sofosbuvir; and 99% ( 95% CI, 95 to 100 ) in the group that received 24 weeks of Ledipasvir - Sofosbuvir and Ribavirin.

No patient discontinued treatment owing to an adverse event.

The most common adverse events were fatigue, headache, and nausea.

In conclusion, the treatment with a once-daily, single-tablet regimen of Ledipasvir and Sofosbuvir resulted in high rates of sustained virologic response among patients with HCV genotype 1 infection who had not had a sustained virologic response to prior Interferon-based treatment. ( Xagena )

Afdhal N et al, NEJM 2014; Epub ahead of print

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