Originally published by our sister publication Pharmacy Practice News

By Gina Shaw

Implementation of a best-practice alert (BPA) in the electronic health record (EHR) led to a significant decrease in switches to two-drug antiretroviral therapy (ART) among HIV patients with hepatitis B virus (HBV) coinfection, reported researchers from the Icahn School of Medicine at Mount Sinai, in New York City, during a session at IDWeek 2024, held in Los Angeles.

Approximately 5% to 10% of people with HIV in the United States are also coinfected with HBV. Two-drug regimens are not recommended for patients with chronic HBV infection, but current guidelines do not address their use in those with HBV susceptibility and/or core antibody reactivity. A 2023 case surveillance study at Mount Sinai identified four patients with HBV infection or reactivation after a two-drug ART switch: two with HBV susceptibility, one with core antibody reactivity and one with surface antigen reactivity prior to the switch (J Acquir Immune Defic Syndr 2023;94[2]:160-164).

“Two of them ultimately developed fulminant hepatitis, and one required a liver transplant,” said Melissa Margolis, MD, MSc, a third-year resident in internal medicine at Mount Sinai. “This was the impetus for our study, a quality-improvement [QI] project.”

The investigators created a guidance document that recommended HBV surface antigen (HBsAg), core antibody (HBcAb) and surface antibody (HBsAb) testing at a minimum of six months prior to a two-drug switch. “For those who were surface antigen–positive, we recommended that they not be switched to a two-drug regimen and that they continue or start HBV-active ART,” Dr. Margolis said. “For patients who were surface antigen–negative, the serology from core antibody and surface antibody determined the next steps.”

Patients who were HBsAb-positive and HBcAb-negative were deemed “vaccination immune” and could switch to a two-drug regimen. 

“For patients who were both surface- and core antibody-positive, we recommended a shared decision-making process with a discussion about reactivation risk,” Dr. Margolis said. “For those who were surface- and core antibody–negative, we recommended vaccination and then, if proof of immunity, a switch to a two-drug regimen could be appropriate. Lastly, for those who are isolated core antibody–positive, we made the guidance fairly conservative, deeming them intermediate risk and recommending that they not be switched to a two-drug regimen.”

That guidance was incorporated into a BPA associated with three two-drug HIV regimens: dolutegravir-rilpivirine (Juluca, GSK), dolutegravir-lamivudine (Dovato, ViiV Healthcare) and intramuscular cabotegravir-rilpivirine (Cabenuva, ViiV). The alert went live in the Mount Sinai EHR on Feb. 1, 2023; the study examined retrospective data from the year prior to the intervention, and compared it with data from February 2023 to February 2024.

The two primary objectives were to increase the percentage of patients screened for HBV (sAg, cAb, sAb) within one year prior to a two-drug regimen switch, and to decrease the number of switches among a composite group that included those with HBV infection (sAg+) and isolated cAb+ (the intermediate-risk category). The study population included 306 patients: 161 from the pre-intervention period and 145 from the post-intervention period.

Incorporation of the BPA into the EHR led to a significant increase in screening for HBV, with 71% of patients receiving complete serology within one year prior to a switch, compared with just 30% before the alert was implemented.

“In the composite group, the group we are most worried about for reactivation events as well as infections, we also saw a significant decrease in the number of switches in the post-intervention period,” Dr. Margolis said. “Prior to implementing the alert, 12 patients in that group were switched to a two-drug regimen, while post-intervention, only one surface antigen–positive individual was switched.”

Given the rising popularity of two-drug regimens and the new antiretrovirals in the pipeline, HBV screening in people with HIV becomes increasingly important, Dr. Margolis said. “Through a simple QI BPA alert, we were able to increase the percentage of those screened, as well as decrease the number of two-drug regimens among those most likely to be at increased risk for HBV-related events.”

Dr. Margolis reported no relevant financial disclosures.