Experiences and Perspectives From Women Taking Investigational Therapy for Hepatitis C Virus During Pregnancy

Abstract

Objective: Describe the experiences and perspectives among pregnant people with chronic HCV infection receiving ledipasvir/sofosbuvir (LDV/SOF) therapy during pregnancy. Methods: We conducted semi-structured, in-depth interviews within an open-label, phase 1 study of LDV/SOF therapy among pregnant people with chronic HCV infection. Participants took 12 weeks of LDV/SOF and were interviewed at enrollment and again at the end of treatment. We transcribed the interviews verbatim and coded them with NVivo software for subsequent inductive thematic analysis. Results: Nine pregnant people completed the study, leading to 18 interview transcripts. All participants identified as women. Eight women acquired HCV through injection drug use, and 1 through perinatal transmission. We identified 3 themes. (1) Treatment for HCV during pregnancy with LDV/SOF was tolerable and convenient. (2) Women described that taking investigational LDV/SOF increased their self-esteem and sense of well-being due to possible cure from HCV, and they felt that the experience of working hard to achieve cure may potentially prevent return to drug abuse in the future. (3) Women appreciated researchers and providers that gave non-judgmental care and communicated honestly, and preferred person-centered care that acknowledges women’s individual needs. Conclusions: Women stated that cure from HCV would be “life-changing,” and described antepartum treatment for HCV with LDV/SOF as tolerable and desired, when provided by non-judgmental providers. Antepartum treatment was found to be acceptable by study participants and should be further evaluated to combat the increasing HCV epidemic among young persons, including pregnant people.

Identifying barriers and facilitators of the inclusion of pregnant individuals in hepatitis C treatment programs in the United States

“…This positive perspective has been noted in other studies [24,25]. In work by Kislovskiy et al, interviews of nine pregnant people who were enrolled in an open-label, phase 1 study of ledipasvir/sofosbuvir during pregnancy yielded themes related to treatment during pregnancy being tolerable and convenient; taking DAAs increased individuals' sense of well-being due to the possibility of cure; and participants appreciated the provision of non-judgmental, person-centered care and communication [23]. Although Kislovskiy et al's study was conducted among individuals who had already agreed to enroll in an early stage trial, it is reassuring that these individuals similarly identified a cure from HCV as "life changing" and were very positive about antepartum treatment [23].…”

“…Kushner et al surveyed patients and identified a high willingness to take DAA therapy during pregnancy if it would result in prevention of perinatal transmission; factors associated with receptivity to treatment included being of reproductive age range and having a prior history of HCV treatment [24]. These attitudes were echoed by pregnant participants in a phase 1 DAA trial [23]. In qualitative work exploring DAA implementation in the primary care setting, prescribing providers in Delaware expressed positive attitudes regarding HCV treatment, while also identifying patient-and practice-level barriers [30].…”

“…In work by Kislovskiy et al, interviews of nine pregnant people who were enrolled in an open-label, phase 1 study of ledipasvir/sofosbuvir during pregnancy yielded themes related to treatment during pregnancy being tolerable and convenient; taking DAAs increased individuals' sense of well-being due to the possibility of cure; and participants appreciated the provision of non-judgmental, person-centered care and communication [23]. Although Kislovskiy et al's study was conducted among individuals who had already agreed to enroll in an early stage trial, it is reassuring that these individuals similarly identified a cure from HCV as "life changing" and were very positive about antepartum treatment [23]. In addition to these specific motivations for HCV treatment, pregnancy represents a pivotal opportunity for treatment due to the unique health care access experienced by pregnant individuals, some of whom may not have insurance or regular contact with a clinician outside of pregnancy.…”

“…Additionally, HCV cure during pregnancy may mitigate the perinatal risks associated with HCV, including perinatal transmission [22]. Yet, patient and clinician perspectives on HCV treatment during pregnancy are unclear [23][24][25]. Understanding the perspectives of these stakeholders regarding HCV treatment in this critical window of opportunity is essential to furthering the goal of HCV eradication.…”

Defer no more: advances in the treatment and prevention of chronic hepatitis C virus infection in children

“…Access to well tolerated HCV treatment during pregnancy to achieve cure and prevent vertical transmission is appealing to women with HCV infection [105,106]. Combined with universal screening in pregnancy, DAA treatment during pregnancy could prove a potent mechanism for achieving HCV elimination in women and children, and we believe it should be a high priority for further study.…”