Amitabh Bachchan and hepatitis B: the test came back reactive. What needs to happen next, and who is liable if it does not?

By Ramon Martins Andrade, attorney (OAB/RJ 188.374)

English translation of an article first published in Portuguese: read the original.

In May 2017, on being appointed Goodwill Ambassador of the World Health Organization for hepatitis in South-East Asia, Amitabh Bachchan said in public: “As a person living with hepatitis B, I know the pain and sufferings that hepatitis causes”, according to the WHO news release of 12 May that year. The statement gives no information on markers, treatment or prognosis, and nothing is said here about the actor’s doctors or health services. What is taken from it is the gesture: a man who knows his own diagnosis chose to speak about it in public when taking on a role in raising awareness of the disease. And the question that matters to the reader begins exactly where the gesture ends, at the moment a health unit or a laboratory hands over a “reactive” hepatitis B test.

That result is the first step of a ladder that public health calls the cascade of care: confirming the infection, assessing the liver, deciding between treating and monitoring, testing and vaccinating those who live with the person, and keeping up follow-up for years. At each step someone drops out, and the number of those who reach the end is small all over the world. This article climbs that ladder: what science measures about the losses, what has changed in the guidelines, how Brazil’s Sistema Único de Saúde (SUS, the Unified Health System) organizes each stage, how three countries opened different doors, and when an omitted step comes to carry legal consequences.

254 million people, 13% diagnosed: where the cascade breaks

WHO’s Global hepatitis report 2024 estimated that 254 million people were living with hepatitis B in 2022, a year with 1.2 million new infections; of the 1.3 million deaths from viral hepatitis, 83% were caused by hepatitis B. The two figures that measure the cascade are the starkest in the report: only 13% of people with chronic infection had been diagnosed, and around 3%, or 7 million, had received antiviral treatment by the end of 2022. WHO noted that testing and treatment coverage had stalled and that only 60% of the countries that reported data offer free testing and treatment, wholly or partly, in the public sector.

The Polaris Observatory consortium (Lancet Gastroenterology & Hepatology, 2023), modelling 170 countries, arrived at 257.5 million HBsAg-positive people in 2022, of whom 36.0 million had been diagnosed; of the 83.3 million eligible for treatment under the criteria then in force, only 6.8 million were being treated. On prevention, only 46% of babies received the birth dose of the vaccine on time, and only 3% of mothers with a high viral load received antivirals to reduce transmission to the child. For Latin America, a 2026 review (Ridruejo and colleagues, Expert Review of Anti-infective Therapy) estimates that only 23% of people with chronic hepatitis B in the Region of the Americas are diagnosed and 4.5% treated, and proposes coupling the decentralization of testing with active linkage to care.

Loss does not happen only before the test. The US CDC working group that reviewed the screening recommendations in 2023 found rates of linkage to care of between 36% and 78% after diagnosis, and treatment prescribed for 18% to 32% of patients with chronic infection. The cost of that gap shows up years later. In a multicentre study across eight hospital networks in the state of Victoria, Australia (Moussa and colleagues, Journal of Gastroenterology and Hepatology, 2026), 219 of the 1,203 new cases of liver cancer were linked to hepatitis B; in 26% of them, cirrhosis was discovered only together with the cancer, and linkage to a specialist was associated with 8.4 times greater odds of being on antiviral treatment (adjusted odds ratio). The authors speak of missed opportunities, in a country where antivirals are subsidized.

A counterpoint helps to locate the break. A meta-analysis of 329 studies on key populations (Su and colleagues, Lancet Regional Health – Western Pacific, 2026) showed that, among people living with HIV, linkage to hepatitis B care reaches 88.1% and treatment 88.9%, while vaccination stands at 16.3% and screening at 68.8%. The data suggest that, within a programme that already follows the patient, the cascade holds on to people, and that the loss is concentrated at the ends: testing those who have never been tested and vaccinating those who live with the infected person.

What the reactive test already proves and what still needs to be confirmed

The Protocolo Clínico e Diretrizes Terapêuticas (PCDT, the clinical protocol and therapeutic guidelines) for Hepatitis B and Coinfections, updated by Ordinance SECTICS/MS No. 25 of 18 May 2023, organizes screening around HBsAg, the virus’s surface antigen, tested in a blood sample or by rapid test, which gives a result within 30 minutes and can be done at the primary care unit; according to the Ministry of Health, users may ask for the rapid test on their own initiative. The protocol explains why screening matters: the infection “often follows a subclinical or anicteric course, with no evident signs of liver disease until complications develop”, such as cirrhosis and hepatocellular carcinoma.

A reactive HBsAg on its own, however, does not close the investigation. The 2023 PCDT recommends that the diagnosis be made with at least two tests: preferably reactive HBsAg and detectable HBV-DNA; alternatively, reactive HBsAg with reactive total anti-HBc or HBeAg. The chronic form is defined by HBsAg remaining reactive for six months or more. On receiving the result, it is worth asking for the full report, with method and date, and asking which confirmatory test will follow.

What has changed in the guidelines: treating more people, with simpler rules

On 29 March 2024, WHO published new guidelines for the prevention, diagnosis, care and treatment of chronic hepatitis B, with “expanded and simplified” treatment criteria for adults and now also for adolescents, wider antiviral prophylaxis in pregnancy, point-of-care viral load testing, and strategies for adherence and retention in care. The logic is that of the cascade: each additional test, each repetition months apart, each biopsy is one more step at which the patient can be lost.

The 2023 Brazilian protocol adopts as the upper limit of normal for the enzyme ALT 35 U/L for men and 25 U/L for women, and indicates treatment when ALT exceeds 1.5 times that limit (52 U/L and 37 U/L) in at least two consecutive measurements at least three months apart, together with HBV-DNA of 2,000 IU/mL or more; with normal ALT, the decision turns on the assessment of fibrosis, with a “grey zone” on elastography (6 to 9 kPa). The preliminary report submitted to Public Consultation No. 98 of 2026 proposes a different yardstick, and says why: “In line with the update of the WHO guidelines published in 2024, this PCDT has adopted simplified criteria for the indication of treatment”. The ALT limit falls to 30 U/L in men and 19 U/L in women; treatment becomes indicated from age 12 with HBV-DNA of 2,000 IU/mL or more and ALT above those values; where viral load testing is not available, two abnormal ALT results 6 to 12 months apart are enough; an APRI score above 0.5, a calculation made from routine blood tests, comes to count as a sign of fibrosis; diabetes and steatotic liver disease are added as conditions that indicate treatment; the grey zone disappears. Universal once-in-a-lifetime screening is extended from people over 20 to people over 18, and HBeAg ceases to serve as an alternative confirmatory marker.

The consultation was opened in the Diário Oficial da União (the Official Gazette) of 29 September 2026, on a proposal from the Secretariat of Health and Environmental Surveillance, with 20 days for contributions. Until the new ordinance is published, the 2023 protocol is the one in force, and it is the standard against which the care provided today is measured. For anyone who has been told they “do not need treatment yet”, the change is a reason to ask for reassessment when the final text comes out.

In Brazil: notify, link to care, test contacts and vaccinate

The 2025 Epidemiological Bulletin on Viral Hepatitis, a special issue published by the Ministry of Health in July, records 302,351 confirmed cases of hepatitis B between 2000 and 2024. The detection rate fell from 8.1 to 5.3 per 100,000 inhabitants between 2014 and 2024, with territorial inequality: Porto Velho (36.5) and Rio Branco (31.7) led the state capitals in 2024. Over the period, 30,965 cases (10.3%) occurred in pregnant women, and 21,065 deaths were related to hepatitis B. The bulletin restates the WHO targets, diagnosing at least 90% of people with active infection and treating 80% of those who need treatment, but does not publish the Brazilian cascade: how many notified people had a viral load test, how many are in follow-up, how many are on treatment. The country counts cases; the path of each case after the test does not appear.

The first step after the result is notification, and it has a statutory basis. Lei 6.259/1975 (the law on epidemiological surveillance and the National Immunization Programme) makes suspected or confirmed cases of the diseases on a list drawn up by the Ministry of Health compulsorily notifiable to the health authorities (art. 7, II), requires physicians and other health professionals to notify (art. 8), makes notification confidential, in the wording given by Lei 14.289/2022 (the confidentiality law for people living with HIV, viral hepatitis, Hansen’s disease and tuberculosis) (art. 10), and treats non-compliance as a health infraction (art. 14). The list is in Annex 1 of Annex V to Consolidation Ordinance GM/MS No. 4/2017, which, as worded by Ordinance GM/MS No. 10.175 of 23 January 2026, lists viral hepatitis as subject to weekly notification. The 2023 PCDT states that detection of HBsAg “is already considered a criterion for case notification”, and the text under consultation sets registration in Sinan (the Notifiable Diseases Information System) within seven days, noting that the primary care electronic record does not replace notification and that “under-reporting of cases is still a major challenge”. Notification is what sets surveillance in motion to reach the contacts.

The second step is assessment, and the third, the decision between treating and monitoring. Not everyone with hepatitis B starts antivirals on the same day; those who do not meet the criteria remain under monitoring, which is active management, with defined tests, return interval and responsible service. The SUS offers tenofovir, entecavir, tenofovir alafenamide and peginterferon alfa, with the aim, in the Ministry’s words, of “reducing the risk of disease progression”. The criteria for access to antivirals through health plans and confidentiality at work are covered in the article on hepatitis B and C in the SUS, in health plans and at work (in Portuguese).

The fourth step is the one that depends most on taking the news home. The PCDT requires that “all first-degree relatives and household and sexual contacts of HBsAg-reactive individuals must be tested”, and that susceptible people, without a complete vaccination schedule, be vaccinated. The vaccine is available in the SUS “for all unvaccinated people, regardless of age”, in three doses for adults, and Lei 6.259/1975 requires the compulsory vaccinations of the National Immunization Programme to be given “systematically and free of charge” (art. 3, sole paragraph). The service may not disclose the diagnosis to the family without authorization, because Lei 14.289/2022 allows confidentiality to be breached only in cases provided for by law, for just cause or with the person’s express authorization; that is why guidance on how and whom to tell is part of care, not a favour.

Two scenarios run on a short deadline. In pregnancy, the PCDT requires all pregnant women to be screened, preferably in the first trimester; when indicated, tenofovir prophylaxis “should be started between the 24th and 28th week of pregnancy, ideally at the 24th week”. The newborn receives the vaccine and hepatitis B immunoglobulin, the latter “in the delivery room or within the first 12 hours and, if that is not possible, within 24 hours of birth, and may be given up to 7 (seven) days of life at the latest”, and it is for local health managers to guarantee the workflow. The text under consultation proposes changing the indication for prophylaxis and removing the requirement of follow-up in high-risk prenatal care. Before chemotherapy, a biologic or a transplant, screening calls for HBsAg and total anti-HBc, because viral reactivation “can occur both in HBsAg-reactive individuals and in those who are HBsAg non-reactive and anti-HBc reactive”; depending on the risk, with rituximab and stem cell transplantation in the highest group, management ranges from monitoring to antiviral prophylaxis.

Three countries, three ways in

The United States chose the widest door. In March 2023, the CDC began recommending screening of “all adults aged ≥18 years at least once during a lifetime”, with a triple panel at the first draw (HBsAg, anti-HBs and total anti-HBc) and testing for anyone who asks for it, “regardless of disclosure of risk”, because many people are reluctant to disclose stigmatized risks. The document estimates up to 2.4 million infected people in the country, two thirds of them possibly unaware. The triple panel serves the cascade: in a single draw it separates the infected, the protected and the susceptible who should be vaccinated.

France kept, in the official guidance of its health insurance system, screening targeted at populations at risk of exposure, but opened another door: since 1 September 2024, the Mon test IST programme has allowed the hepatitis B test to be done at a laboratory without a medical prescription, free of charge for those under 26 (Décret n° 2024-725 and arrêté of 8 July 2024). With a positive result, the biologist informs the person and refers them to a physician, a midwife, a free testing centre (CeGIDD) or a hospital. The starting point explains the choice: a 2016 survey, published by Santé publique France in 2019, estimated that only 17.5% of people with chronic hepatitis B knew of their own infection.

The United Kingdom bet on referral. NICE guideline PH43, reviewed in 2017 without changes, directs general practitioners and primary care nurses to offer testing to adults and children at increased risk, “particularly migrants from medium- or high-prevalence countries”, requires them to ensure that people who are diagnosed “are referred to specialist care”, and charges commissioners with commissioning a “fully integrated care pathway” between testing and treatment in primary and secondary care. These are three designs: test everyone, remove the intermediary, or test those at highest risk and tie down the referral. On paper, Brazil is among the broadest, with universal once-in-a-lifetime screening and rapid testing at the primary care unit; the weakness, as the data show, lies in the steps that follow.

When the omitted step gives rise to liability

The PCDT is not a statute, but it describes what the public system regards as the expected standard of care, and it therefore works as the yardstick for the service. Lei 15.378/2026, the Estatuto dos Direitos do Paciente (the Patients’ Rights Statute), adds the duty to inform: patients have the right to information about their health condition and treatment, and that information “must be accessible, up to date and sufficient for the patient to be able to make a decision” (art. 12, § 1). A reactive report handed over without any explanation of the next step will hardly meet that yardstick. The same Statute guarantees access to the medical record without having to give reasons and a copy free of charge (art. 19), and Lei 8.080/1990 (the Organic Health Law) ensures access “at all levels of care” (art. 7, I).

In private services, art. 14 of the Código de Defesa do Consumidor (CDC, the Consumer Protection Code) makes the service provider liable, regardless of fault, for harm caused by defects in the service (with § 1 defining as defective a service that “does not provide the safety that the consumer may expect of it”); § 4, however, makes the personal liability of self-employed professionals depend on a finding of fault. In public services, and in private entities that provide a public service, the liability of the legal entity follows art. 37, § 6, of the Constitution, with the right of recourse against the agent in cases of intent or fault. The hospital that does not set up the workflow for immunoglobulin in the delivery room, or the service that starts rituximab without screening for hepatitis B, is liable under a different regime from the physician, and it is the expert evidence that determines whether the omission affected the course of the disease.

Where the harm cannot be attributed with certainty to the omission, the STJ (the Superior Court of Justice) allows compensation for the lost chance. In REsp 1.254.141/PR, decided by the Third Panel in 2012 in a case of inadequate treatment of breast cancer, the headnote records that compensation “could never correspond to the final loss, but only to the lost chance”; transposing this to hepatitis B depends on the specific case and the technical evidence. The reverse also holds: reactivation that occurs despite correctly performed screening and prophylaxis is a risk of the treatment, not a failure by whoever followed the protocol. The logic is the same as in the critical result that the laboratory saw and nobody communicated (in Portuguese): the test exists to prompt a course of action, and it is the action that was missing that is examined.

Before deciding

In my view, the weak point of hepatitis B in Brazil is not the way in, which on paper is among the broadest, but the passage from one step to the next: the report that never becomes a consultation, the viral load that is never drawn, the return visit with no date, the family that was never tested. That is why the useful questions are concrete: what is the confirmatory test, who will receive it, what is the next date, do the people I live with need to be tested and vaccinated, and, if pregnancy or immunosuppressive treatment is on the horizon, was screening done before the first dose. Dated reports, referrals, the prenatal record booklet and the medical record, which the patient has the right to request, tell most of the story. Anyone can contribute to the public consultation on the new protocol, and the general route through the public system is set out in the guide to the SUS (in Portuguese). When one of these steps has failed, whether on the side of the patient and the family or on the side of the health service that needs to review its own workflow, get in touch with the firm with the test report and the dates of what came afterwards.

About the author

Ramon Martins Andrade (OAB/RJ 188.374) is a lawyer who graduated from UFRJ in 2011, with master’s degrees from Université Sorbonne Nouvelle and from the Naval War College (EGN, Brazilian Navy). He is currently a researcher in Human Rights and Health at ENSP/Fiocruz.

This content is for information and education only. It does not constitute legal advice, advertising of results or any guarantee of outcome, under Rule 205/2021 of the Brazilian Bar Association (OAB).