Respect for pregnant women as persons

Sexually transmitted infection screening is a primary component of prenatal care, as many pregnant women are at risk for these conditions which are treatable, often asymptomatic, and may be transmitted to and harmful for offspring. This opportunity to diagnose and treat is also key because many reproductive-aged women do not access healthcare outside of pregnancy. Appreciation for the role of prenatal care in supporting women’s health outside of pregnancy has increased in recent years given mounting evidence of the connection between prenatal and long-term health. Prenatal infectious disease care nevertheless disproportionately values fetal health. For example, the CDC recommends universally screening for HIV, hepatitis B virus (HBV) and syphilis, all less prevalent than HCV, but posing relatively high risks of severe complications in offspring. Effective treatments for each of these infections are approved for use in pregnancy and treating pregnant women substantially reduces perinatal transmission and offspring complications.8

However, compared with HIV, HBV and syphilis, the rate of perinatal HCV transmission is relatively low and there are no currently recommended interventions particularly effective for decreasing perinatal transmission. Perinatal HCV can be harmful for infants, but they may also spontaneously clear the virus or receive curative treatment, whereas congenital HIV, HBV and syphilis are more likely to confer lifelong complications. By contrast, untreated chronic HCV ultimately causes serious liver disease in most affected women. In this sense, existing universal sexually transmitted infectious disease screening in pregnancy is motivated chiefly by offspring interests, whereas HCV screening would most directly and significantly benefit women. Likewise, other common prenatal infectious disease screening, for example, for group B streptococcus and rubella, are exclusively for infant benefit. Given universal screening for several less-common infectious diseases for which there are treatments to reduce perinatal transmission, failure to universally screen for HCV—which is more likely to harm women than their offspring—is a conspicuous omission which evokes treatment of pregnant women as ‘mere means.’

Beneficence: Universal screening more effectively promotes case-identification

Universal screening would more reliably achieve the goal of any HCV screening in pregnancy: identifying mother–infant pairs in need of postpartum treatment and follow-up. Effectiveness of risk-stratified HCV screening is limited because it requires assessment of highly stigmatised risk factors and deviation from routine care, creating additional ‘holes in the swiss cheese.’ For example, retrospective review of prenatal patients at University of Maryland in 2016 (n=1426) found that only 36% (28/78) with documented risk factors were screened for HCV. Meanwhile, 32% (9/28) of the women with documented risk factors who received indicated screening were diagnosed with HCV, suggesting significant potential for missed cases with risk-stratification.13 Reluctance to disclose illicit substance use history and sexual risks, especially during pregnancy, and the possibility of not knowing the extent of one’s sexual exposure, further undermines effectiveness of the current approach.14–16

One concern raised for universal screening is that it increases frequency of false positives, which may cause undue distress, outweighing potential benefits. However, this potential collateral harm could be avoided by reflexively performing highly specific confirmatory viral testing for any initial positives prior to reporting results. Another potential concern regarding true-positive HCV diagnoses is that they could cause maternal distress from having a diagnosis for which treatment is not immediately available, particularly regarding inability to effectively prevent perinatal transmission. However, the troubling underlying suggestion is that permitting HCV infections to go undiagnosed may be in women’s best interests due to their inability to appropriately deal with the results.

Identifying latent HCV infections benefits women by enabling them to pursue treatment postpartum and lifestyle modifications to decrease disease progression or transmission (eg, reduced alcohol consumption, clean needle programme), and may prompt interventions by revealing undisclosed substance use disorders or other latent risk factors. Likewise, missed diagnoses of an indolent disease harm women in the long term. Further, 36%–88% of perinatally acquired HCV infections do not resolve spontaneously, and increased prevalence of acute and chronic HCV in pregnancy impacts infants’ baseline risk.17–19 Infants would also benefit from universal prenatal screening because childhood screening is entirely contingent on known maternal status. Notwithstanding cost-effectiveness, permitting missed diagnoses for a serious yet treatable disease disregards women’s and infants’ best interests.

Beneficence: Universal screening in pregnancy strategically advances treatment goals

Since treatment cannot be offered during pregnancy, the utility of prenatal HCV screening is contingent on women and infants receiving indicated postpartum treatment and follow-up, typically via referral to gastroenterology or infectious disease specialists. Logistic barriers to such care, including loss of pregnancy’s universal health insurance coverage and increased loss-to-follow-up on transfer of care, limit screening’s ability to improve outcomes.20 21 Deferring treatment until after completion of breastfeeding further complicates this issue. Similarly, most infants whose mothers have known HCV are not followed through 18 months of age as indicated by paediatric guidelines, largely because there is no standardised process for identifying and tracking at-risk infants.17 18 Lack of effective follow-up for cases identified with risk-stratification undermines cost-effectiveness of prenatal HCV screening and challenges the move to substantially increase spending on a public health intervention that may not achieve its goals.17

Why expand screening if positive results merely generate ‘two birds in the bush’ who are unlikely to benefit? This is a significant concern within our public health ethics framework, which requires both a priori evidence of effectiveness for screening and distribution of resources to maximise population health and minimise opportunity costs.22 23 However, public health screening programme must also promote equity.24 Dismissing potential health benefits of HCV diagnosis due to systemic failure to follow-up appropriately on actionable clinical information generated by risk-stratified screening may reinforce existing inequities in maternal and child health.

Historically, chronicity of HCV would be established over 6 months before initiating treatment, given the financial burden, side effects and prolonged duration of legacy treatments. In the DAA/opioid era, IDSA recommends reproductive-aged women be treated immediately, even for acute HCV, specifically because they may become pregnant and risk perinatal transmission. Treatment does not require complex medical supervision and can be completed in as few as 8 weeks. In lieu of external referral, obstetricians may consider initiating treatment immediately postpartum. More research and interdisciplinary collaboration are needed to inform best practices and breastfeeding recommendations. Protocols for ensuring paediatric follow-up are also needed. Theoretically, diagnosing and treating during pregnancy would be the most efficient, effective way to decrease disease burden: the proverbial ‘bird in the hand.’ Although evidence of safety and efficacy of DAAs during pregnancy, including impact on perinatal transmission, are not yet available, a phase I clinical trial is underway (Clinicaltrials.gov: NCT02683005), and pilot data suggest treatment in pregnancy is safe and effective.6

Universal access to health insurance for pregnant women in the USA is a major strategic advantage of treating during pregnancy or immediately postpartum.25 Due to underlying disparities, HCV disproportionately affects pregnant women on public health insurance (OR 5.5, 95% CI 4.7 to 6.4).26 Notwithstanding long-term cost-effectiveness and improved health outcomes with DAA treatment, high short-term costs associated with treating identified cases may disincentivise both universal screening and treatment in pregnancy.25 These economic considerations are relevant to national policies for HCV screening and treatment. Value-based care agreements between health insurers, governments and pharmaceutical companies may help resolve conflicts of interest between patients and other stakeholders.

Simultaneous treatment for women and prevention for infants is on the horizon. Modelling on successes with HIV, universal screening would be imperative if DAAs were approved for use in pregnancy. Capturing HCV’s true prevalence in this population would emphasise the urgency of advancing this ideal, while avoiding missed diagnoses would optimise the existing strategy of postpartum treatment and follow-up. Pregnancy is a critical inflection point for two lives, and universal HCV screening would have health benefits for women and infants.

Justice: Risk-stratification reinforces stigma

History of IVDU and sexually transmitted infections, including HIV, are the primary and secondary criteria for HCV screening under current guidelines. Some professional organisations also recommend screening women with intranasal drug use, ‘unregulated tattoos,’ or sexual partners with HCV. These risk factors are highly stigmatised and commonly under-reported, especially in pregnancy when women may fear being judged as ‘bad mothers.’ Pregnant women may also have reasonable concerns about disclosing illicit drug use as this can prompt state-mandated reporting, criminal or civil charges related to fetal abuse, and subsequent child welfare investigations: concerns which may disproportionately harm women of colour and other underserved groups. Similarly, involuntary drug testing discourages at-risk women from seeking prenatal care.27 28

Providers’ screening practices may express underlying biases, exacerbate self-stigma and further decrease disclosure. Logistically, risk-screening and initial prenatal laboratory testing often occur at brief nurse intake visits prior to physician-or-midwife-based prenatal care. This may predispose against disclosure, given the absence of an established therapeutic relationship. Recognition that stigmatised risk factors are prone to under-reporting, coupled with the desire to not miss cases, also prompts broadening of screening criteria by individual providers or practices. For example, 72/100 pregnant women screened for HCV in the University of Maryland study did not have any documented risk factors. While this finding may reflect incomplete documentation, just 1/72 (1.3%) of the women without documented risk factors had HCV, versus 9/28 (32%) of those with documented risk factors.13 We believe the discrepancy reflects the anecdotally common practice of using informal criteria, such as ‘late to prenatal care’ status, marijuana use and subjective appraisal of women’s or their partners’ appearances, to dictate HCV screening in an effort to avoid missed cases.

Despite the good intentions of screening those without formal risk factors, these ad hoc, proxy criteria illustrate how risk-stratified HCV screening—because HCV, IVDU and risky sexual practices are highly stigmatised—may functionally express moral judgement against pregnant women. This represents testimonial injustice, as screening a woman without documented risk factors asserts distrust of her word, particularly given that IVDU, the dominant means of transmission, lacks plausible deniability. Providers who screen women who lack documented risk factors may be unlikely to be transparent with patients regarding how or why their care deviates from standard practice. Use of informal criteria for risk-stratification is problematic because perceived HCV risk becomes a signifier for moral culpability, even among women who screen negative.

Universal screening would circumvent this issue and could decrease stigma against both HCV and IVDU by sending the message that risk transcends race, class or perceived moral character. This approach may decrease the impact of stigma on prenatal care in general by eliminating the practice of singling out certain pregnant women, whether by formal or informal criteria, as morally dubious. This would build on past work done in the realm of universalising HIV screening, an endeavour motivated partly by the public health imperative to capture all cases, but also the aim of normalising and reducing stigma associated with selective testing.29 Empirical evaluations of routine HIV testing as an intervention to reduce stigma have suggested that, with proper communication, universal screening may be an effective means of reducing stigma associated with HIV testing.30–32