Abstract
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.
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.
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