Background Lactose is widely used as a filler in the manufacture of pharmaceutical tablets and capsules, which should be taken into account to avoid adverse effects in lactose-intolerant patients.
Purpose A survey was conducted to find out the lactose content in several drugs used in the treatment of hepatitis C, in order to select lactose-free drugs as therapeutic options suitable for lactose-intolerant patients.
Material and methods A list of drugs approved or pending approval in Spain for the treatment of hepatitis C was obtained from the webpages of the agencies in Spain (Agencia Española de Medicamentos y Productos Sanitarios) and the European Union (European Medicines Agency). Information about the list of excipients and particularly lactose content was obtained from the product information sheets. Lactose-free medicinal products suitable for lactose-intolerant patients were selected according to viral genotype.
Results There are 16 medicinal products approved for hepatitis C treatment and 1 pending approval in Spain. Ten of these products contained lactose in amounts ranging from 4.94 mg to 156.8 mg per pharmaceutical form unit. A full list of lactose contents is given in the following table.
With regard to direct-acting antivirals, lactose-free sofosbuvir/velpatasvir (Epclusa) should be the first therapeutic option for lactose-intolerant patients of all viral genotypes. Genotype 4 would have paritaprevir/ombitasvir/ritonavir (Viekirax) as second option.
Moreover, when ribavirin treatment is indicated, lactose-free copegus, rebetol solution, ribavirin normon and ribavirin teva should be the therapeutic options in lactose-intolerant patients.
Conclusion General therapeutic options recommended for the treatment of hepatitis C should be adapted in the case of lactose-intolerant patients. Lactose-free medicinal products are available in order to avoid adverse reactions.
No conflict of interest
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