Women who received postpartum direct-acting antivirals (DAAs) for hepatitis C virus (HCV) before hospital discharge were significantly more likely to complete their course of treatment than those who did not receive initial medication while in the hospital, based on data from a new study of more than 100 individuals.
Access to treatment often remains limited for pregnant and postpartum women living with HCV infections, wrote Leah M. McCrary, MD, of Washington University School of Medicine in St. Louis, and colleagues.
“Pregnancy can be a critical healthcare access point for many women of reproductive age,” said corresponding author Laura R. Marks, MD, also of Washington University School of Medicine, in an interview. To make meaningful progress toward HCV elimination in the US, clinicians need to meet people where they are and whenever they are diagnosed with HCV, she said. “For pregnant women, this can and should include hospitalizations for labor and delivery,” Marks said.
Despite hospitals’ ability to initiate HCV treatment, most healthcare providers have not traditionally thought of HCV as an inpatient problem, Marks explained. The current study, published in O&G Open, was a chance “to flip the script and try something new,” she said.
The researchers initiated a program of beginning care with DAAs for women with HCV immediate postpartum. The program, known as Meds to Beds, involved inpatient consultations to review bloodwork and discuss HCV treatment. The medication was prescribed as a new home discharge medication and delivered to the patient’s bedside at the time of discharge, as would be the case with any other new home medication, Marks told Medscape Medical News.
In the current study, the researchers reviewed records from 149 treatment-naïve pregnant women who had tested positive for HCV and delivered babies at a single center between January 2020 and September 2023. The mean age of the participants was 34 years, 71% were White women, and 81% had Medicaid as their primary insurance. Approximately 95% of the women reported substance use during pregnancy, and 74.5% had a diagnosis of opioid use disorder as a complication of pregnancy.
The final study population included 125 women with HCV who were referred for HCV care; 92 were referred to an outpatient HCV clinic (usual care) and 33 received bedside consultation and a prescription for DAAs. Of the inpatient group, 30 were discharged with a prescription for DAAs, 28 of whom were able to leave labor and delivery with DAAs in hand. By contrast, just under half (45%) of the outpatient group presented to a clinic for HCV consultations.
The primary outcome was treatment completion, defined as patient-reported completion of DAAs, sustained virologic response, or negative HCV viral load at 4 weeks or later after hospital discharge. The median time between delivery and HCV prescription was 2 days in the inpatient group vs 57 days in the outpatient group.
Overall, women in the inpatient referral group were 4.7 times more likely to complete treatment than those in the outpatient group after controlling for variables including age, Medicaid status, illicit drug use, and engagement in prenatal care. Ultimately, two thirds of the women in the Meds to Beds group (66.67%) reported HCV treatment completion compared with 34% of those in the outpatient group.
“One of the findings I was surprised by was the high level of treatment completion even among women who did not attend follow-up HCV clinic appointments,” Marks told Medscape Medical News. “Our research demonstrated that just giving women a full course of HCV treatment medications at the time of discharge from the hospital was enough,” she said. Although seeing each patient back in clinic with a confirmed “yes” that they took all their medication, followed by bloodwork, would be ideal, it isn’t strictly necessary, Marks said.
The current study underscores that the most important action HCV healthcare providers can take is to simply provide access to treatment to anyone who wants it, said Marks. “This includes eliminating as many barriers as possible along the way, without making that offer contingent on a requirement to return to an outpatient clinic,” she said.
Remarkably few barriers exist to implementing an inpatient initiation of HCV treatment, Marks said. “However, while access for many Medicaid patients is excellent most commercial healthcare plans still do require a prior-authorization process that can take several days,” she said. Broader implementation of HCV treatment as a routine discharge medication requires decreasing barriers to HCV treatment among commercial insurance plans, she said.
Seizing an Opportunity
“Pregnancy and the postpartum period represent a unique clinical situation in which pregnant patients can be tested for hepatitis C, and then treatment can be initiated in the postpartum period,” said Aleksandr M. Fuks, MD, professor and chair of the Department of Obstetrics and Gynecology at East Tennessee State University, Johnson City, Tennessee, in an interview.
Fuks said he was surprised that 87% of the patients who tested positive for HCV during the current pregnancy had at least 1 prior pregnancy affected by HCV without treatment in the interpregnancy period. “This suggests that the opportunity to treat HCV in the interpregnancy period is lost in the vast majority of cases, and the study provided at least one way to approach this issue,” he said.
Barriers to inpatient initiation of DAAs include the short inpatient stay for most women during and after delivery and the availability of appropriate counseling and resources to provide medications to initiate treatment before women leave the hospital, Fuks told Medscape Medical News.
“Also, historical guidance to defer DAA treatment until after lactation plays a big role in some patients’ reluctance to initiate treatment during breastfeeding,” said Fuks.
Additional research should focus on accumulation of safety data for the use of DAAs during lactation and the extrapolation of bedside programs from large highly academic delivery hospitals (as in the current study) to smaller community-based institutions, Fuks told Medscape Medical News. The current study was a retrospective cohort design with inherent biases; therefore, a prospective, randomized, controlled trial of adequate power should be another future research goal, Fuks added.
This study was supported by the Washington University Institute of Clinical and Translational Sciences through a grant from the National Center for Advancing Translational Sciences of the National Institutes of Health. McCrary and Marks disclosed receiving funding from Gilead’s Frontlines of Communities in the US program. Fuks disclosed no financial conflicts of interest.
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