The hepatitis C antiviral drug market is changing, away from protease inhibitors and interferon regimens and towards highly-effective, easily-tolerated, interferon-free oral therapies – the first of which is Gilead’s mega-blockbuster Solvadi (sofosbuvir), says new research.

Sales of Solvadi are projected to be close to $10 billion during its first year, but several strong competitors are manoeuvring strongly to narrow the market gap by introducing an HCV antiviral that can outdo Gilead’s drug, notes the study, from Frost & Sullivan.

Work on development of hepatitis C antivirals has amplified, with rising incidence rates and the intense need for curative therapy in the absence of a preventative vaccine.  Around 160 million people worldwide are chronically infected, and at least 350,000 die annually from HC-infected liver diseases such as liver cancer and conditions requiring transplantation. The US alone accounts for nearly five million of the world’s HCV-affected population, mostly baby-boomers entering the 65-plus age bracket, the report shows.

“Chronic infection with HCV remains a serious public health threat. Until an efficacious preventative vaccine emerges, the patient strength will remain sizeable due to the likelihood of high-risk behaviours from a substantial portion of the population and the emergence of resistant viral strains,” commented F&S healthcare principal analyst Randy Budros. 

The market is looking for a reasonably-priced and convenient alternative to Solvadi, says the study. Gilead’s drug holds promise in fighting the virus, but its astronomical price - $84,000 for a 12-week course of treatment – has unleashed a firestorm of criticism from government agencies, patient advocacy groups and payers, and also a US Congressional request for Gilead to justify its pricing, which is projected to increase Medicare’s Part D prescription drug benefit spending as much as $6.5 billion in 2015 alone.

“Gilead and other future market entrants have to create a compelling pricing rationale by driving home the potential cost savings from a high-performance, all-oral regime, zeroing in on the downstream cost saving such as the reduction of liver transplants. Equally crucial is the need to make HCV antivirals more affordable and accessible to patients,” says Mr Budros.

However, with recent clinical data showing close to 100% cure rates for Solvadi, future contenders will be hard pressed to succeed in the marketplace, the study cautions. Competitors must aim to satisfy the until-now unmet need for a once-daily, ribavirin-free, all-oral, pan-genotypic regimen that has a short treatment duration, it says.