Background and importance Sofosbuvir/velpatasvir (SOF/VEL) is an oral regimen approved for patients with hepatitis C virus (HCV). To date, no pharmacokinetic data exist on the impact on efficacy and safety of this regimen when it is crushed and mixed with liquids or food.
Aim and objectives To describe the case of a 65-year-old man patient with HCV infection who successfully achieved a sustained viral response (SVR) when SOF/VEL oral combination was administered crushed and dissolved in 10 mL of water.
Material and methods A 65-year-old man presented with HCV infection, genotype 4, with minimal fibrosis (F0–F1). He was operated on for laryngeal neoplasia and treated with radiotherapy 10 years previously, presenting secondary swallowing problems since then. His last evaluation of liver fibrosis was 4.7 kPa (1 year before treatment). He showed elevated levels of aspartate aminotransferase (43 U/L), alanine aminotransferase (48 U/L) and gamma-glutamyl transferase (94 U/L) at the beginning of treatment, and a normal range for other liver profile values. Off-label treatment with crushed SOF/VEL dissolved in 10 mL of water for 12 weeks was decided, and serum HCV-RNA was determined at +12 weeks, +24 weeks (SVR) and 1 year post-treatment.
Results The patient presented undetectable serum HCV-RNA at +12 weeks, +24 weeks (SVR) and 1 year post-treatment, and normal liver enzymes values were reached at +12 weeks post-treatment. SOF/VEL tablets only took 1 min to be dissolved in water, with a bitter taste, according to the patient.
Conclusion and relevance Crushed SOF/VEL was effective in eradicating HCV in our patient. However, there is little evidence to support the practice of crushing SOF/VEL for reliable conclusions, and hence more studies are needed to determine its bioavailability when administrated in a way different from the conventional one. We aim to develop management guidelines for antiviral drugs with different administrations.
References and/or acknowledgements No conflict of interest.
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