The Latest in the Hepatitis B Drug Pipeline

According to the Hepatitis B Foundation, hepatitis B is the most common serious liver infection in the world, with over 292 million people living with a chronic infection. Though incidence is lower in the United States, up to 80,000 Americans will still become newly infected with hepatitis B each year and more than 2 million Americans are chronically infected. While many people infected with hepatitis B virus (HBV) may clear the virus in the acute phase (the first 6 months), some people are unable to clear the virus and it progresses to chronic hepatitis B.

“Treatment with one of the seven FDA approved antivirals, intended to reduce liver damage and extend patient survival, may require lifelong medication therapy,” says H. Kelley Riley, MD, chief medical officer, EnvisionRxOptions, a pharmacy benefits and services company headquartered in Twinsburg, Ohio. “Current antiviral therapy may be near $1,000 per month, therefore prevention strategies provide an effective way to significantly reduce spending.”

“Since hepatitis B can be both acute and chronic, it has a significant impact on both pharmacy and medical spend,” says David Calabrese, chief pharmacy officer at OptumRx and a member of the Managed Healthcare Executive editorial advisory board. “Commonly used oral antiviral therapies often must be taken indefinitely in order to maintain suppression of the hepatitis B virus; and long-term complications associated with hepatitis B, including liver disease and impairment, the need for liver transplantation, and hepatocellular carcinoma, drive up healthcare costs.”

Cost and cures

Cost and cures are at the forefront of needs for new hepatitis B treatments.

“The ultimate goal is to identify drugs or a combination of drugs that will substantially increase the functional cure rate for the infection and potentially reduce the duration of time needed for therapy,” says Calabrese. “Several novel therapies in the pipeline for the treatment of hepatitis B show promise in early-stage data and the recent success of antiviral therapies for hepatitis C has also sparked interest and development for identifying cures for hepatitis B.”

• JNJ-3989 (formerly ARO-HBV, Arrowhead Pharmaceuticals/Janssen Pharmaceuticals) is a third-generation subcutaneously administered RNA interference therapy in phase 1/2 studies as a curative treatment for patients with chronic HBV.

• Inarigivir soproxil (Spring Bank Pharmaceuticals), is an oral treatment designed to selectively act within cells infected with HBV to inhibit viral replication and induce the cell’s antiviral defense. Inarigivir is also in phase 2 studies for treatment of HBV, conducted by Gilead Pharmaceuticals, as a combination therapy with Vemlidy (tenofovir alafenamide, Gilead) compared to Vemlidy monotherapy.

• Myrcludex B (bulevirtide, MYR Pharmaceuticals) is a first-in-class subcutaneously administered treatment currently in phase 2b studies for chronic HBV and hepatitis D virus (HDV) coinfection. According to MYR, HDV is the most severe form of viral hepatitis infection, it only occurs in people coinfected with HBV, and current treatment options are very limited.

Related:How the Specialty Pharmaceutical Market is Changing

“In keeping with the trend of specialty medications, pharmaceutical manufacturers will likely set high prices for these drugs; and for payers, it becomes even more complex when multiple drugs from different brand manufacturers are used in combination to increase the likelihood of a functional cure of hepatitis B,” says Calabrese. “PBMs are essential partners with physicians, patients, and payers in managing complex diseases like hepatitis B and using specialty pharmacy management to improve health outcomes and reduce costs while ensuring affordable access to needed medications.”

“Payers should be cognizant of preventive guidance; there may be increased encouragement to screen for HBV and administer preventive vaccination to a broader scope of individuals,” says Riley. “Treatments for those with chronic hepatitis B are still long-term and costly; and future pipeline treatments may be curative, which as seen in hepatitis C, could come with a high cost for a short amount of time. The future will most likely be a continued push for screening and prevention. Due to the global need to treat chronic hepatitis B, manufacturers are likely to continue research and conduct development to pursue a cure for hepatitis B.”

Read More:How Payers Are Keeping Specialty Drug Costs Down

Erin Johanek, PharmD, RPh is a staff pharmacist at Southwest General Health Center, Middleburg Heights, Ohio.