Hepatology Month in Review: April 2024

Coming off of a historic March with the US Food and Drug Administration (FDA) approval of resmetirom (Rezdiffra), April reached equal significance as the oral thyroid hormone receptor-β selective agonist became available in US pharmacies early in the month. In other hepatic pipeline news, Surrozen announced phase 1a safety and pharmacodynamic activity data for SZN-043, a pivotal first step in the agent’s development for severe liver diseases. April also saw notable new research for hepatitis C virus (HCV), including potential ways to increase treatment access and data about infection during pregnancy.

Accordingly, the editorial team of HCPLive Hepatology spotlights our top coverage of key hepatic news in this April 2024 month in review.

Resmetirom Becomes Available in the US, Other Pipeline News

Resmetirom (Rezdiffra) Now Available in US Pharmacies, Marks Turning Point in NASH Management

On April 9, 2024, Madrigal Pharmaceuticals announced the availability of resmetirom in US pharmacies, nearly a month after it became the first and only FDA-approved therapy in nonalcoholic steatohepatitis (NASH) when it earned accelerated approval for noncirrhotic NASH with moderate to advanced fibrosis. The oral thyroid hormone receptor-β selective agonist is indicated as an adjunct to diet and exercise, and its continued approval may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

SZN-043 Demonstrates Safety, Pharmacodynamic Effect for Cirrhosis in Phase 1a Trial

Surrozen announced safety and pharmacodynamic activity data from its phase 1a clinical trial of SZN-043 in healthy volunteers and patients with cirrhosis, a pivotal first step in its development for severe liver diseases. Results showed SZN-043 demonstrated acceptable safety and tolerability in all study participants with evidence of target engagement, Wnt signal activation, and effects on liver function, serving as the basis for Surrozen’s initiation of enrollment in a phase 1b study in alcohol-associated hepatitis.

Increasing Access to HCV Treatment

Facilitated Telemedicine Through Opioid Treatment Program Increases HCV Treatment Access

Health care access is a longstanding issue among many underserved patient populations, but findings from this study suggest integrating facilitated telemedicine into opioid treatment programs may provide a promising solution for overcoming barriers to HCV care. Compared with off-site referral to a hepatitis specialist, HCV treatment administered through facilitated telemedicine integrated into opioid treatment programs resulted in significantly faster initiation of direct-acting antiviral (DAA) therapy and greater cure rates among HCV-seropositive persons with opioid use disorder.

Related: Increasing Access to HCV Treatment Through Facilitated Telemedicine, with Andrew Talal, MD

For further insight into study results and other potential applications of facilitated telemedicine, we spoke with Andrew Talal, MD, professor in the department of medicine at Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo.

DAA Use Increased After State Medicaid Programs Eased HCV Treatment Restrictions

Findings from this study suggest access to curative HCV treatment could be improved by loosening or eliminating insurance coverage restrictions related to liver disease severity, sobriety, or prescriber specialty, as evidenced by a significant increase in the number of patients treated for HCV across 32 state Medicaid programs that eased or eliminated their coverage restrictions compared to those that maintained restrictions.

“In this study, from 2015 to 2019, treatment of HCV with DAAs increased after state Medicaid programs eased coverage restrictions compared with states that did not ease restrictions,” Sonya Davey, MD, resident physician in internal medicine at Harvard Medical School/Brigham and Women's Hospital, and colleagues wrote. “Further reductions or eliminations of these restrictions may maximize the public health effect of these safe and effective treatments for HCV.”

Preventing Vertical HCV, HBV Transmission

Postpartum Hepatitis Flare Risk Increases After Discontinuation of Antiviral Therapy

Although tenofovir disoproxil fumarate was found to be safe and effective for preventing mother-to-child transmission of hepatitis B virus (HBV) in female patients with a high viral load during the second or third trimester of pregnancy, study results also called attention to an increased risk of hepatitis flares during the postpartum period after nucleos(t)ide analog discontinuation, with 5 out of 7 participants experiencing a flare within 6 months of stopping tenofovir disoproxil fumarate.

Safety, Efficacy of DAAs in Reproductive-Age Women Aid Prevention of Vertical HCV Transmission

HCV is on the rise among reproductive-aged adults and rates of perinatal infection are expected to grow as well, but findings from this study provide hope for the targeted treatment of this patient population, showing greater rates of sustained virologic response (SVR) following DAA therapy with a more favorable safety profile among reproductive-age female patients than their male counterparts.

Regardless of the treatment type, SVR was reached significantly more frequently among female patients (98.8%) compared to male patients (96.8%). Treatment was carried out according to schedule in the majority of patients (98.5% of females and 98.1% of males) with a low chance of severe adverse events, although investigators pointed out death occurred more commonly in men (0.3% vs 0.1%; P = .03).