AbbVie’s Maviret, known as Mavyret (glecaprevir/pibrentasvir) in the U.S., just became the only therapy approved in the EU for both acute and chronic hepatic C virus (HCV) , removing the need to confirm chronicity before treatment. While 2020 clinical guidance already recommended prompt treatment for acute HCV, the drug’s previous chronic-only indication could still lead to additional documentation, reimbursement hurdles or delays.The expanded indication brings the drug’s approved use in line with existing clinical recommendations.
Maviret box. Image credit: AbbVie
“We no longer have to go through additional steps to check for chronicity or worry about how far back they got the infection,” Mudra Kapoor, vice president of Global Medical Affairs, Specialty & Global Medical Operations, Medical Affairs and Health Impact at AbbVie, said in an interview with R&D World.
Mudra Kapoor, vice president of Global Medical Affairs, Specialty & Global Medical Operations, Medical Affairs and Health Impact at AbbVie. Image courtesy of AbbVie
There’s still a belief that physicians should test for chronicity, whether a patient has had the infection for over six months, before treatment, she said.
Routine practice “needs to get to a point where the minute you diagnose someone as positive for HCV, you treat them,” Kapoor said. “That’s not where we are, but it’s where we need to go.”
Maviret is a once-daily, direct-acting antiviral, taken in an eight-to-16-week regimen. In the Phase 3 M20-350 trial that supported the approval, 96.2% of patients achieved sustained virologic response 12 weeks after finishing the eight-week regimen.
The drug is a fixed-dose combination of glecaprevir, which blocks the enzyme HCV needs to cleave its polyprotein into the mature viral proteins for replication, and pibrentasvir, which blocks a protein that is essential for viral RNA replication and assembling new virus particles.
Why doctors used to wait before treating
A small subset of HCV patients may spontaneously clear the infection, which is likely where the idea to wait for chronicity came from, Kapoor said. A 2006 systematic review of 31 studies found that, without treatment, a weighted average of 26% of acute HCV patients spontaneously clear the infection, though individual study results ranged widely, from 0% to 80%.
“It also dates back to a time when HCV treatments didn’t have the benefit-risk profile they have today,” she said. “Patients were using interferon injections three times a week, with low rates of clearing the virus, significant side effects and a lot of other logistics to manage.”
“The landscape of hepatitis C has evolved considerably since MAVIRET was first approved in 2017,” Kapoor said in a statement. At the time, she said, global elimination efforts, including the WHO’s 2030 targets, focused largely on treating the millions of people already living with chronic infection. As curative treatments became widely available, she said, the field increasingly recognized that elimination would also require diagnosing people earlier and preventing transmission, which is what the acute-indication trial was designed to address.
“When you look at the benefit-risk equation today, it would almost be a disservice to patients not to treat them with [Maviret],” she added.
While a patient waits to see if their infection will clear or become chronic, they can transmit the virus to others, a risk of the wait and see approach.
“What we have to remember is, yes, we want to give this person the best chance of cure, now we have medication that lets us do that. But beyond that, look at the broader picture, at society, and the socioeconomic benefit you gain by treating this one person, given the therapies we have available now,” Kapoor said.
The barriers beyond the drug itself
“Changing the standard of care takes more than approving a treatment or getting it to market,” Kapoor said. “There’s a whole ecosystem that needs to work together to eliminate the disease.”
AbbVie has entered pricing and access agreements with policymakers and global health organizations.
In 2019, Washington state selected AbbVie to provide HCV medication through a subscription-style payment program designed to expand access while containing state drug costs, making Maviret the state’s preferred HCV medication. In 2018, the company signed a voluntary licensing agreement with the Medicines Patent Pool, a UN-backed nonprofit, agreeing to make Maviret available in 99 low- and middle-income countries (LMICs) and territories through royalty-free arrangements with generic drug manufacturers. However, Médecins Sans Frontières Access Campaign sent an open letter to AbbVie in 2021, stating that the drug “continues to remain out of reach for many people with hepatitis C in LMICs.”
How Lithuania made strides to eliminating HCV
It is possible to eliminate HCV, Kapoor said, pointing to substantial progress in Lithuania. There, AbbVie sponsored HCV screening tests at one health center, according to a paper published in Viruses. In May 2022, Lithuanian health authorities launched a national HCV screening program, giving general practitioners a financial bonus to conduct antibody testing. By 34 months in, the program had tested more than 75% of the 1945 to 1994 birth cohort, and the number of patients treated had more than tripled compared to the same period before the program.
Despite that progress, the researchers who published the program’s results concluded Lithuania is not currently on track to meet the WHO’s 2030 elimination targets and would need to increase treatment levels and lift fibrosis-stage restrictions on who qualifies for antivirals to get there.
AbbVie has supported the screening effort, but Kapoor was clear that industry involvement alone won’t close the gap to elimination.
“It takes more than AbbVie to meet these goals,” Kapoor said. “We need policymakers to take action, we need payers to take action, and we need everyone to actually want to eliminate HCV.”
“There are a couple of other bright spots like that around the globe, which gives us confidence that if we all work together across the whole ecosystem, we can get there. But that work needs to happen,” Kapoor said.
“That future is possible, and AbbVie is completely committed to it,” she said.
Filed Under: Hepatology, Infectious Disease, Regulatory affairs
