5PSQ-119 A survey of lactose content in drugs used for hepatitis c treatment

• Published in: European journal of hospital pharmacy. Science and practice Vol. 25; no. Suppl 1; pp. A219 - A220
• Main Authors: Garrigues, C Salom, Delgado, A Retamero, Marimon, RM Parés, Fresquet, X Sanchez, Benavente, J Serrais, Martí, D Ferrández
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 01.03.2018; BMJ Group
• Subjects: Drugs; Hepatitis; Hepatitis C; Interferon; Lactose; Lactose intolerance; Pharmaceuticals; Section 5: Patient safety and quality assurance; Spain
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2018-eahpconf.472

BackgroundLactose 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.PurposeA 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 methodsA 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.ResultsThere 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.Abstract 5PSQ-119 Table 1 Active ingredient Product Lactose (mg) Daclatasvir Daklinza 30 mg, 60 mg, 90 mg 58, 116, 173 Dasabuvir Exviera 250 mg 4.94 Glecaprevir/pibrentasvir Maviret 300/120 mg 7.48 Grazoprevir/elbasvir Zepatier 50/100 mg 87.02 Paritaprevir/ombitasvir/ritonavir Viekirax 12.5/75/50 mg Ribavirin Copegus 200 mg Rebetol capsules 200 mg 40 Rebetol solution 40 mg/ml Ribavirin aurobindo 200 mg 45 Ribavirin normon 200 mg Ribavirin teva 200 mg Simeprevir Olysio 150 mg 78.4 Sofosbuvir Sovaldi 400 mg Sofosbuvir/ledipasvir Harvoni 90/400 mg 156.8 Sofosbuvir/velpatasvir Epclusa 400/100 mg 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.ConclusionGeneral 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