AbbVie a obtenu un avis positif du CHMP1Comité des médicaments à usage humain pour réduire à 8 semaines la durée de traitement par MAVIRET® (glecaprevir/pibrentasvir) des patients atteints d’hépatite C chronique de génotype 3, naïfs de traitement avec une cirrhose compensée.
London, 10 January 2020 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection.
– MAVIRET™ is now available as a shorter, 8-week, once-daily option for treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT)1, 2, 4, 5 and 6
– Marketing authorization is supported by 97.9 percent cure1Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. rate across this group of patients with no reported virologic failures2Brown RS, Hezode C, Wang S, et al. Preliminary Efficacy and Safety of 8-Week Glecaprevir/Pibrentasvir in Patients with HCV Genotype 1–6 Infection and Compensated Cirrhosis: The EXPEDITION-8 Study. Presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, U.S., November 13, 2018
– Analysis evaluating MAVIRET as an 8-week, once-daily treatment option for treatment-naïve, compensated cirrhotic, GT3 HCV patients is ongoing
Paris, le 14/06/2018 – Accès aux soins et innovation pour tous. A l’occasion des 19èmes Journées Nationales d’Infectiologie qui ont débuté mercredi 13 juin, TevaSanté rappelle son implication dans la lutte contre le VIH à travers la mise à disposition d’une offre large de médicaments génériques. Teva entend ainsi permettre l’accès aux soins pour tous, rendre les innovations possibles dans le cadre d’un système de santé contraint.
ATLAS-2M study met its primary endpoint, showing similar efficacy of cabotegravir and rilpivirine administered every eight weeks compared to four-week administration.