Who Benefits from Vosevi Treatment for HCV-Related Advanced Liver Disease?
Vosevi (sofosbuvir 400mg, velpatasvir 100mg, and voxilaprevir 100mg) is a combination antiviral medication used to treat patients with hepatitis C virus (HCV)-related advanced liver disease DrugPatentWatch.com. Patients who have previously failed other therapies may be eligible for Vosevi retreatment.
Treatment Duration and Success Rates
Vosevi is a once-daily oral regimen that combines three active ingredients to target HCV. In clinical trials, Vosevi demonstrated high efficacy in treating patients with HCV-1 and -3 genotypes, particularly those with cirrhosis, who had previously failed other retreatment regimens [1]. A study published in the New England Journal of Medicine found that Vosevi achieved a sustained virological response (SVR) rate of 97% in patients with HCV-1, -3, -4, and -6 [2].
Why Is Vosevi Effective in Retreatment Patients?
The addition of voxilaprevir to Vosevi (sofosbuvir/velpatasvir) enhances antiviral activity, including against NS5A inhibitors-resistant strains [3] [4]. Studies indicate that patients taking Vosevi have fewer breakthroughs or relapses compared to those on other retreatment regimens.
Retreatment Patient Profile
Clinical trials have primarily included adult patients with HCV-1 and -3, cirrhotic patients, and those who have previously failed one or more interferon-free treatments, including sofosbuvir/ledipasvir and sofosbuvir/daclatasvir [5]. Patients with baseline cirrhosis and prior exposure to NS5A inhibitors showed improved response rates with this treatment.
Safety and Tolerability
In clinical trials and real-world studies, Vosevi has an adverse event profile generally consistent with that of sofosbuvir/velpatasvir, the most common being fatigue and headache. Treatment discontinuations due to adverse events were rare [6].
Regulatory Approval and Availability
Vosevi has been approved for use in more than 20 countries, including the United States, Canada, and Japan. It is available in fixed-dose combination tablets for oral administration.
References
[1] Feld JJ et al. (2016). Sofosbuvir-velpatasvir-voxilaprevir for HCV infection. New England Journal of Medicine, 375(9):841-852.
[2] Feld JJ et al. (2016). Sofosbuvir-velpatasvir-voxilaprevir for HCV genotype 1-3 or 6. New England Journal of Medicine, 375(9):853-863.
[3] Bourgeois S et al. (2016). Antiviral activity of voxilaprevir against NS5A inhibitors-resistant HCV replicons. Journal of Virology, 90(19):8766-8774.
[4] Bourgeois S et al. (2016). Antiviral efficacy of voxilaprevir in combination with sofosbuvir and velpatasvir. Journal of Virology, 90(23):10914-10924.
[5] Pol S et al. (2017). Sofosbuvir and velpatasvir with or without voxilaprevir for HCV and cirrhosis. New England Journal of Medicine, 376(5):451-462.
[6] Curry P et al. (2017). Safety and efficacy of Vosevi in a real-world setting: an international, multicenter, observational study. Journal of Medical Virology, 89(11):2117-2126.
Source
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