VIEKIRAX (ombitasvir/paritaprevir/ritonavir), fixed-dose direct-acting antiviral combination, EXVIERA (dasabuvir), direct-acting antiviral

INFECTIOLOGY - NEW MEDICINAL PRODUCT

Opinions on drugs - Posted on Jun 26 2015

Inclusion

VIEKIRAX, like EXVIERA, has Marketing Authorisation in the treatment of chronic hepatitis C, in combination with other medicinal products, in adults infected with HCV genotype 1.
VIEKIRAX also has Marketing Authorisation in adults infected with HCV genotype 4.
VIEKIRAX and EXVIERA may provide a cure for the majority of patients with hepatitis C, with or without extrahepatic manifestations. Treatment should be offered as a priority in all patients whose hepatic disease is at fibrosis stage F3 or F4 and in certain special populations. A specific mention concerns patients infected with the genotype 3 virus, for whom early treatment is desirable. Patients at fibrosis stage F2 should also receive new treatments within a short time. For stages F0 or F1, treatment may be delayed depending on the progression of the disease and the context of the pathology.
They provide a minor improvement, as do DAKLINZA and OLYSIO, in the treatment of chronic hepatitis C genotypes 1 and 4 given:

their significant virological efficacy similar to that observed with the available sofosbuvir-based combinations (sofosbuvir/daclatasvir, sofosbuvir/simeprevir and sofosbuvir/ledipasvir) with a good level of evidence,
their satisfactory safety profile,
the significant risk of developing cross-resistance in the event of treatment failure,
the potential for drug interactions,
the current therapeutic strategy which mainly includes a combination with sofosbuvir, without interferon.

Substantial

minor

Therapeutic use

Évaluation des médicaments

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