Dataset Information

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.

SUBMITTER: Kislovskiy Y

PROVIDER: S-EPMC8481705 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background. Hepatitis B virus (HBV) infections are perinatally transmitted from chronically infected mothers. Supplemental antiviral therapy during late pregnancy with lamivudine (LAM), telbivudine (LdT), or tenofovir (TDF) can substantially reduce perinatal HBV transmission compared to postnatal immunoprophylaxis (IP) alone. However, the cost-effectiveness of these measures is not clear. Aim. This study evaluated the cost-effectiveness from a societal perspective of supplemental antiviral agents for preventing perinatal HBV transmission in mothers with high viral load (>6 log10 copies/mL). Methods. A systematic review and network meta-analysis were performed for the risk of perinatal HBV transmission with antiviral therapies. A decision analysis was conducted to evaluate the clinical and economic outcomes in China of four competing strategies: postnatal IP alone (strategy IP), or in combination with perinatal LAM (strategy LAM + IP), LdT (strategy LdT + IP), or TDF (strategy TDF + IP). Antiviral treatments were administered from week 28 of gestation to 4 weeks after birth. Outcomes included treatment-related costs, number of infections, and quality-adjusted life years (QALYs). One- and two-way sensitivity analyses were performed to identify influential clinical and cost-related variables. Probabilistic sensitivity analyses were used to estimate the probabilities of being cost-effective for each strategy. Results. LdT + IP and TDF + IP averted the most infections and HBV-related deaths, and gained the most QALYs. IP and TDF + IP were dominated as they resulted in less or equal QALYs with higher associated costs. LdT + IP had an incremental $2,891 per QALY gained (95% CI [$932-$20,372]) compared to LAM + IP (GDP per capita for China in 2013 was $6,800). One-way sensitivity analyses showed that the cost-effectiveness of LdT + IP was only sensitive to the relative risk of HBV transmission comparing LdT + IP with LAM + IP. Probabilistic sensitivity analyses demonstrated that LdT + IP was cost-effective in most cases across willingness-to-pay range of $6,800 ∼ $20,400 per QALY gained. Conclusions. For pregnant HBV-infected women with high levels of viremia, supplemental use of LdT during late pregnancy combined with postnatal IP for infants is cost-effective in China.