Harvoni’s growth spurt despite Hep C market downturn

Maviret sales show external decline with ₩14.4billion·₩57.3 billion·₩46.9 billion in sales in 2018·2019·2020

Harvoni makes ₩6.8 billion·₩15.7billion·₩18.4 billion in sales...the only product to see a surplus in its market

Zepatier·Sovaldi·Daklinza·Sunvepra... ₩2.6 billion·₩0.7 billion·₩0.6 billion·₩17 million

With the domestic hepatitis C treatment market externally contracting from ₩120 billion to ₩68 billion in three years, the rapid strides of growth made by Harvoni in the market is drawing attention.

 

On the 20th, Dailypharm analyzed the hepatitis C treatment market based on IQVIA data.

 

The overall sales in the Hep C market amounted to ₩121.2 billion·₩89.9 billion·₩85.2 billion·₩68.8 billion in the years 2017·2018·2019·2020.

 

The leading product in the market was AbbVie’s Maviret, which recorded ₩47.9 billion in sales last year.

 

Maviret still is the sole lead product that accounts for 70% of the market, however, its sales fell ₩10.4 billion compared to 2019.

 

Externally, Zepatier·Sovaldi·Daklinza·Sunvepra also showed sales of ₩2.6 billion·₩0.7 billion·₩0.6 billion·₩17 million in 2020 and recorded a decline in sales compared to the previous year.

 

While products in the market showing negative growth, Gilead’s Harvoni was the only one showing an upward trend.

 

Harvoni’s performance in the last 3 years (2018·2019·2020) was ₩6.8 billion·₩15.7billion·₩18.4 billion.

 

With regards to its growth rate, it has ranked second to Maviret, accounting for 4.35%·13.88%·19.88% of the market.

 

In the same period, Maviret’s market share was 12.50%·69.80%·75.43% The recent negative growth seen in sales of hepatitis C treatments recently is presumed to be due to the decreased inpatient treatment rate of hepatitis C in the COVId-19 pandemic.

 

In addition, the reasons for Harvoni's sole increase in market share in the domestic market is attributed to its changed indication that allows its use in patients with renal impairment in March last year, and its reinforced safety and cost-effectiveness from the RWD presented at the Liver Week in May this year.

 

In March 2020, Harvoni’s indication was changed to allow its use in patients with any degree of renal impairment, including end-stage renal disease (ESRD) on dialysis without dosage adjustment in addition to the previously approved for patients with mild-to-moderate renal impairment, allowing its use and prescription to a wider patient population.

 

Also, the first multicenter RWD(Real World Data) on Harvoni in Korea was presented at Liver Week 2021, reinforcing the strengths of Harvoni, the only PI-free DAA agent in Korea, and having a positive effect on the domestic market share.

 

As most hepatitis C treatments have excellent treatment effects, we now need to consider drug safety, cost-effectiveness, and convenience of administration, including drug-drug interactions (DDI) in addition to getting cured.

 

Harvoni is the only hepatitis C DAA agent that does not contain a protease inhibitor (PI).

 

This allows less drug-drug interactions, and therefore may be used in patients with comorbidities that require multiple drug intake, and is safe to be used by people with all stages of liver disease.

 

Protease inhibitors can cause serious liver damage when taken by hepatitis C patients with severe liver disease.

 

The U.S.

 

Food and Drug Administration (FDA) had stated that patients with moderate to severe liver disease (Child-Pugh B, C) should take caution in using drugs containing protease inhibitors.

 

In addition to such precautions, as DAA agents containing protease inhibitors have a narrower scope of use than Harvoni, this also may have had an impact on Harvoni's market share expansion.

 

Harovni’s strength is not limited to its antiviral effect and safety.

 

It is also cost-effective.

 

Over 98% of the hepatitis C patients in Korea belong to genotype 1 and 2 of the virus, with over half of the patient population (45-59%) having genotype 1 of the virus.

 

In this context, the 8-week treatment regimen of Harvoni that allows a cost reduction of 30% compared to existing hepatitis C treatments gained attention as the treatment option that can reduce the treatment burden for patients with genotype 1 of hepatitis C virus.

 

Harvoni’s 8-week treatment regimen can be considered in treatment-naïve genotype 1 patients without cirrhosis who have pretreatment HCV RNA less than 6 million IU/mL.

 

Also, Harvoni can be taken orally once a day in a single tablet without regard to food.

 

This simple administration method increased convenience in administration for patients.

 

Other hepatitis C treatments have limitations in administration, requiring more than 1 table intake during or after meals, but a single tablet of Harvoni is taken orally once daily with or without food.

 

The World Health Organization (WHO) had proposed eliminating hepatitis by 2030, by raising awareness of the viral infectious disease hepatitis C and expand active prevention, testing, and treatment of the disease.

 

Hepatitis C is a type of infection in which the blood or body fluids of a patient infected with the hepatitis C virus is transmitted through the injured skin or mucous membrane of normal people.

 

With no vaccine available for its prevention, and new infections usually being asymptomatic, 70-80% of the patients are diagnosed after developing chronic HCV infection.

 

30% of these patients develop cirrhosis or liver cancer, therefore prevention and prompt treatment and diagnosis are required.

 

Hepatitis C can be cured with only 8 to 12 weeks of treatment without concern about developing resistance with the introduction of direct-acting antivirals (DAA).