The recent first global approval of glecaprevir/pibrentasvir has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

In July 2017, glecaprevir/pibrentasvir (MAVIRET™), developed by AbbVie, received its first global approval in the EU for adult patients with chronic HCV genotype 1–6 infection. Within a week, it was also approved in the US for the treatment of adults with chronic HCV genotype 1–6 infection without cirrhosis and with compensated cirrhosis, as well as the treatment of HCV genotype 1 infection in patients previously treated with a regimen containing either an HCV NS5A inhibitor or an NS3/4A protease inhibitor but not both. [1] Subsequently in mid-August and late September, the drug was also approved, respectively, in Canada[3] and Japan[4], each for the treatment of adults with chronic HCV infection across all major genotypes (GT1-6).

Glecaprevir/pibrentasvir is also indicated in patients with complicated kidney disease and was approved under accelerated assessment by the EMA, and granted Priority Review in the US, Canada and Japan as well as Breakthrough Therapy designation in the US.[5] [6] [3] [4]

Glecaprevir/pibrentasvir is a once-daily, orally administered, fixed dose combination of an HCV NS3/4A protease inhibitor and an HCV NS5A inhibitor; it is said to be a pan-genotypic medicine for patients with chronic hepatitis that is effective within 8 weeks of treatment.[7][5]

The WHO Global Hepatitis Report for 2017 claims that 71 million people worldwide were living with chronic HCV infections in 2015.[8] Of those about 3.4 million are located in the US,[7] and 2 million in Japan.[4]

The once-daily administration, the short 8-week treatment period, and the versatility of glecaprevir/pibrentasvir will appeal to patients, physicians and payors alike, because the simplified and shortened therapy may also translate into cost savings.

Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie stated that, “With MAVIRET, physicians and patients now have a treatment option that is highly effective and has the potential to cure the majority of HCV patients in as short as 8 weeks, regardless of genotype.”[7] He also explained that this was because, “MAVIRET represents an innovation in HCV care … that combines two distinct antiviral agents and has high efficacy even against most genotypes commonly associated with resistance to treatment”.[5]

The label information registered with the FDA contains a black boxed warning about the risk of reactivation of Hepatitis B virus (HBV) in patients co-infected with HCV. The information states that all patients should be tested for HBV prior to initiation of treatment and subsequently monitored for signs of HBV infection reactivation; this warning is also contained within the summary of Product Characteristics registered with the EMA.[9] [10]

For further information related to the first approval of glecaprevir/pibrentasvir please visit Drugs[1],  or to learn more about the overall development of glecaprevir/pibrentasvir across all indications visit AdisInsight[2].

Image credit:  Dr_Kateryna / Fotolia

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