AbbVie allows generic manufacture of HCV treatment in 99 countries

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/NicoElNino)
(Image: Getty/NicoElNino)

Related tags: AbbVie, Hcv, Mavyret, LMICs

A licensing agreement with MPP will allow access to Mavyret in a number of low- and middle-income countries and territories at ‘affordable prices’.

Medicines Patent Pool (MPP) entered into a royalty-free licensing agreement with AbbVie to improve global access to its hepatitis C virus (HCV) treatment, Mavyret (glecaprevir/pibrentasvir).

With the licensing agreement in place, quality-assured manufacturers will be able to produce and sell generic medicines containing glecaprevir/pibrentasvir (G/P).

Improving access

A spokesperson for AbbVie told us that the partnership aims to “address access to [its] HCV treatment in resource-limited settings for the long-term.”

The spokesperson continued, “This agreement supports [AbbVie’s] commitment to helping achieve HCV elimination, and [it] will continue to help simplify treatment, remove barriers to care and improve public health outcomes for people living with HCV worldwide.”

In terms of how quickly the countries covered as part of the agreement would be able to gain access to the treatment, the spokesperson noted this will be arranged between MPP and the World Health Organization prequalified generic manufacturers.

“It will be up to each of the MPP licensees to determine how quickly they may be able to make a quality, generic version of the G/P available,” ​noted the spokesperson.

In a statement, MPP noted that there are 71 million people living with chronic HCV, many of which are located in low- to middle-income countries (LMICs).

According to Raquel Peck, CEO of World Hepatitis Alliance, the deal is a step towards making the treatment available in LMICs.

Claiming over one million lives each year, viral hepatitis is one of the world’s major public health challenges and disproportionately affects people living in LMICs. Therefore access to safe, quality-assured treatments, affordable for all, has to be the fundamental aim of the public health community. This is a big step in that direction,” ​she said.

Addressing the cost

The new wave of treatments, including AbbVie’s Mavyret, have attracted conversation​ for two reasons: efficacy and cost.

Last week​, AbbVie posted data on the treatment showing that 100% of treatment-naïve patients displayed a virologic response 12 weeks after treatment, across patients with genotype 1, 2, 4, 5 and 6. According to the company, overall cure rates vary from 92% to 100%​.

Due to the high cure rates, Gilead’s breakthrough treatment, Sovaldi (sofosbuvir), for example, was first approved with a $1,000 (€875) per-tablet price tag.

While the growing number of competitor treatments in the LMIC market is helping to reduce costs​, patient access remains a challenge.

Outside of this agreement, AbbVie’s spokesperson suggested that the firm works directly with local governments and stakeholders to “help facilitate treatment at sustainable costs”​.

This is not the first time AbbVie and MPP have collaborated to improve access to treatment options for other diseases in LMICs.

“Previously, AbbVie worked with MPP to grant access to HIV medicine lopinavir/ritonavir in Africa, which is the most widely used HIV-1 treatment for second-line patients in the region,”​ the spokesperson explained.

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