World Hepatitis Day 2024

World Hepatitis Day 2024

Viral hepatitis is a significant cause of disease and death globally. Yet powerful new medical tools to combat hepatitis C and E still reach only a tiny fraction of people who desperately need them, especially in low-resource and emergency settings.


To mark World Hepatitis Day (July 28th) we highlight recent MSF research on making these breakthrough products more widely accessible and simpler to use.


For hepatitis C, where groundbreaking antiviral drugs can cure nearly all patients, MSF is developing comprehensive, community-based models of care that offer rapid screening, diagnosis, and treatment under one roof. In some settings programs focus on the specific needs of highly vulnerable populations, such as people living in remote areas, forcibly displaced refugees, or those co-infected with HIV or TB or who inject drugs.


Turning to prevention, MSF is exploring ways to use the Hepatitis E vaccine more effectively in areas where poor sanitation and water quality regularly lead to outbreaks. Studies in a South Sudanese camp for internally displaced people are strengthening evidence for the vaccine’s feasibility, efficacy, safety and community acceptance, especially for pregnant women and their fetuses. Another report analyzes strategies for overcoming barriers to widespread vaccine adoption.


9 result(s)
Conference Material > Abstract
Gignoux EM
Epicentre Scientific Day 2024. 2024 May 23

BACKGROUND

Hepatitis E was first identified in the 1990s, but major epidemics date back to the 1950s. There is no specific treatment, and it can be fatal especially for pregnant women, causing spontaneous abortion and stillbirths. In 2011, the first vaccine was made available, and in 2015, the WHO recommended its use during epidemics, including for pregnant women. However, several major epidemics occurred without vaccine use. The first mass reactive vaccination took place in 2022 at the Bentiu camp in South Sudan, alongside operational research.


METHODS

We assessed vaccination feasibility and acceptance through coverage surveys and conducted focus group discussions on acceptance. We monitored adverse events following immunization (AEFI) for pharmacovigilance. To assess safety in pregnancy, we monitored the pregnancy outcomes of all women identified as pregnant during the vaccination campaign through a census. Despite the significant efficacy shown in a phase 3 clinical trial after three doses, we aimed to evaluate the vaccine's efficacy in South Sudan during an epidemic after administering two doses through a case-control study.


RESULTS

Coverage of at least one dose of the Hecolin vaccine after three rounds was estimated at 86% (95% CI: 84-88), with no cases of severe AEFI. Focus groups revealed strong concern about hepatitis E and high confidence and demand for the vaccine. An emulated target trial showed a relative risk of foetal loss between vaccinated and unvaccinated pregnant women at 1.1 (95% CI: 0.7-1.8). Vaccine effectiveness after two doses was estimated at 88.3% (95% CI: 53.8-97.6) using a test-negative design.


CONCLUSION

We found high vaccine coverage, good acceptance, and demand from the population. There was no evidence of increased risk of foetal loss among vaccinated pregnant women. Despite the small number of cases, the reduced dose regimen appeared effective in reducing disease risk in this highly exposed population.


KEY MESSAGE

Studies from the first mass reactive vaccination against hepatitis E demonstrated high coverage and acceptance, no safety issues among pregnant women, and good effectiveness after two doses.

Conference Material > Poster
Ashakin KAHadiuzzaman MFiruz WRahman ABen-Farhat J et al.
Epicentre Scientific Day 2024. 2024 May 23
Conference Material > Abstract
Nesbitt RAzman ASAsilaza VKEdwards JKNkemenang P et al.
MSF Scientific Day International 2024. 2024 May 16

INTRODUCTION

Hepatitis E causes high mortality among pregnant women, with case fatality risks over 30% and adverse fetal outcomes. There is an evidence gap on the safety of the only licensed vaccine, Hecolin®, in pregnancy. In 2015, WHO recommended vaccine use in response to outbreaks, including pregnant women. In 2022, the first mass reactive vaccination campaign against Hepatitis E was conducted in Bentiu displaced persons camp in South Sudan. We aimed to determine whether vaccination against hepatitis E in pregnancy increased the risk of fetal loss in a cohort of vaccinated and unvaccinated pregnant women.


METHODS

An exhaustive pregnancy census was conducted from 16 May 2022 until 30 June 2022 after the second vaccination round, and women were revisited 28 days after delivery date to document the pregnancy outcome. We used an emulated target trial framework to address biases inherent in observational studies. We matched (1:1, with replacement) vaccinated to unvaccinated women on age, gestational age, and vaccination propensity score, and we estimated cumulative incidence functions for fetal loss in vaccinated compared with unvaccinated women using the Nelson-Aalen estimator.


RESULTS

Among 2741 women who had a pregnancy outcome after the start of the vaccination campaign, 67 (2.4%) were vaccinated before conception, 2036 (74.3%) were vaccinated during pregnancy, and 638 (23.3%) were not vaccinated. Among the 2407 women retained in the matched analyses, the cumulative risk of fetal loss in women vaccinated during pregnancy was 6.38% (95% CI 4.93–7.26) compared with 6.26% (3.9–9.19) among unvaccinated women (risk ratio [RR] 1.02 [95% CI 0.64–1.53]). In an analysis restricted to women vaccinated during pregnancy with less than 90 days gestation, the cumulative risk of miscarriage was 11.01% (95% CI 8.45–13.13) among vaccinated women and 11.62% (6.45–17.09) among unvaccinated women (RR 0.95 [95% CI 0.59–1.66]). In sensitivity analyses, we explored the impact of different matching criteria on the estimated RR and found no qualitative differences with the main analyses, with no evidence of increased risk of fetal loss among vaccinated women.


CONCLUSION

We used an emulated target trial methodology with matching to simulate a vaccine trial in pregnant women after a reactive vaccination campaign. This robust analytical method simulating a vaccine trial attempts to control for bias inherent in observational data. We found no evidence for increased risk of fetal loss among women vaccinated during pregnancy.

Conference Material > Poster
Firuz WAshakin KASchramm BCamelique ODuka M et al.
MSF Scientific Day International 2024. 2024 May 16
Journal Article > ResearchFull Text
Bull World Health Organ. 2023 April 1; Volume 101 (Issue 04); 262-270.
O’Keefe DSamley KBunreth VMarquardt TBobi SE et al.
Bull World Health Organ. 2023 April 1; Volume 101 (Issue 04); 262-270.
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OBJECTIVE
To determine whether a nurse-led model of care for patients with hepatitis C virus (HCV) infections can provide safe and effective diagnosis and treatment in a resource-poor setting in rural Cambodia.

METHODS
The nurse-led initiation pilot project was implemented by Médecins Sans Frontières in collaboration with the Cambodian health ministry in two operational districts in Battambang Province between 1 June and 30 September 2020. Nursing staff at 27 rural health centres were trained to identify signs of decompensated liver cirrhosis and to provide HCV treatment. Patients without decompensated cirrhosis or another comorbidity were initiated at health centres onto combined treatment with sofosbuvir, 400 mg/day, and daclatasvir, 60 mg/day, orally for 12 weeks. Treatment adherence and effectiveness were assessed during follow-up.

FINDINGS
Of 10 960 individuals screened, 547 had HCV viraemia (i.e. viral load = 1000 IU/mL). Of the 547, 329 were eligible for treatment initiation at health centres through the pilot project. All 329 (100%) completed treatment and 310 (94%; 95% confidence interval: 91-96) achieved a sustained virological response 12 weeks post-treatment. Depending on patient subgroups, this response varied from 89% to 100%. Only two adverse events were recorded; both were determined as unrelated to treatment.

CONCLUSION
The safety and effectiveness of direct-acting antiviral medication has previously been demonstrated. Models of HCV care now need to enable greater access for patients. The nurse-led initiation pilot project provides a model for use in other resource-poor settings to scale up national programmes.
Journal Article > ResearchFull Text
Harm Reduct J. 2023 March 4; Volume 20 (Issue 1); 27.
Saayman EHechter VKayuni NSonderup MW
Harm Reduct J. 2023 March 4; Volume 20 (Issue 1); 27.

BACKGROUND

Globally, 9% of people who inject drugs (PWID), a key hepatitis C-infected population, reside in sub-Saharan Africa. In South Africa, hepatitis C seroprevalence in PWID is high. It is almost 84% in Pretoria and hepatitis C genotypes 1 and 3 predominate. Access to hepatitis C care for PWID is inadequate given low referral rates, socio-structural barriers, homelessness and limited access to harm reduction. Traditional care models do not address the needs of this population. We piloted a simplified complete point-of-service care model, a first of its kind in the country and sub-continental region.


METHODS

Community-based recruitment from Pretoria’s PWID population occurred over 11 months. Participants were screened with point-of-care rapid diagnostic tests for HBsAg (Alere Determine™), hepatitis C and HIV antibodies (OraQuick®). Qualitative HCV viremia was confirmed on site with Genedrive® (Sysmex), similarly at week 4, end of treatment and to confirm sustained virological response. Viremic hepatitis C participants were initiated on 12 weeks of daily sofosbuvir and daclatasvir. Harm reduction and adherence support, through directly observed therapy, peer support, a stipend and transport, was provided.


RESULTS

A total of 163 participants were screened for hepatitis C antibody, and 66% were positive with 80 (87%) viremic. An additional 36 confirmed hepatitis C viremic participants were referred. Of those eligible to initiate treatment, 87 (93%) were commenced on sofosbuvir and daclatasvir, with 98% (n = 85) male, 35% (n = 30) HIV co-infected, 1% (n = 1) HBV co-infected and 5% (n = 4) HIV/HBV/HCV triple infected. Some 67% (n = 58) accessed harm reduction packs, 57% (n = 50) opioid substitution therapy and 18% (n = 16) stopped injecting. A per protocol sustained virological response of 90% (n = 51) was achieved with 14% (n = 7) confirmed reinfections following a sustained virological response. HCV RNA qualitative testing performance was acceptable with all sustained virological responses validated against a laboratory assay. Mild adverse effects were reported in 6% (n = 5). Thirty-eight percent (n = 33) of participants were lost to follow-up.


CONCLUSION

In our setting, a simplified point-of-service hepatitis C care model for PWID yielded an acceptable sustained virological response rate. Retention in care and follow-up remains both challenging and central to success. We have demonstrated the utility of a model of care for our country and region to utilize this more community acceptable and simplified practice.

Journal Article > ResearchFull Text
Health Sci Rep. 2023 February 17; Volume 6 (Issue 2); e1119.
Swe TMJohnson DCMar HTThit PHoman T et al.
Health Sci Rep. 2023 February 17; Volume 6 (Issue 2); e1119.
BACKGROUND AND AIMS
In Myanmar, public sector treatment programs for hepatitis C virus (HCV) infection were nonexistent until June 2017. WHO highlights the importance of simplification of HCV service delivery through task-shifting among health workers and decentralization to the primary health care level. Between November 2016 and November 2017, a study was conducted to describe the epidemiological data and real-world outcomes of treating HIV/HCV coinfected patients with generic direct acting antiviral (DAA) based regimens in the three HIV clinics run by nonspecialist medical doctors in Myanmar.

METHODS
HCV co-infection among people living with HIV (PLHIV) from two clinics in Yangon city and one clinic in Dawei city was screened by rapid diagnostic tests and confirmed by testing for viral RNA. Nonspecialist medical doctors prescribed sofosbuvir and daclatasvir based regimens (with or without ribavirin) for 12 or 24 weeks based on the HCV genotype and liver fibrosis status. Sustained virologic response at 12 weeks after treatment (SVR12) was assessed to determine cure.

RESULTS
About 6.5% (1417/21,777) of PLHIV were co-infected with HCV. Of 864 patients enrolled in the study, 50.8% reported history of substance use, 27% history of invasive medical procedures and 25.6% history of incarceration. Data on treatment outcomes were collected from 267 patients of which 257 (96.3%) achieved SVR12, 7 (2.6%) failed treatment, 2 (0.7%) died and 1 (0.4%) became loss to follow-up.

CONCLUSION
The study results support the integration of hepatitis C diagnosis and treatment with DAA-based regimens into existing HIV clinics run by nonspecialist medical doctors in a resource-limited setting. Epidemiological data on HIV/HCV co-infection call for comprehensive HCV care services among key populations like drug users and prisoners in Yangon and Dawei.
Journal Article > CommentaryFull Text
PLoS Negl Trop Dis. 2023 January 5; Volume 17 (Issue 1); e0010969.
Lynch JALim JKAsaga PEPWartel TAMarti M et al.
PLoS Negl Trop Dis. 2023 January 5; Volume 17 (Issue 1); e0010969.
Journal Article > ResearchFull Text
Public Health Action. 2022 June 21; Volume 12 (Issue 2); 96-101.
Kirakosyan OMelikyan NFalcao JKhachatryan NAtshemyan H et al.
Public Health Action. 2022 June 21; Volume 12 (Issue 2); 96-101.
BACKGROUND
Direct-acting antivirals (DAAs) are not widely used for patients with chronic hepatitis C virus (HCV) infection and multidrug- or rifampicin-resistant TB (MDR/RR-TB). We describe the implementation aspects of a new integrated model of care in Armenia and the perceptions of the healthcare staff and patients.

METHODS
We used qualitative methods, including a desktop review and semi-structured individual interviews with healthcare staff and with patients receiving HCV and MDR/RR-TB treatment.

RESULTS
The new integrated model resulted in simplified management of HCV and MDR/RR-TB at public TB facilities. Training on HCV was provided for TB clinic staff. All MDR/RR-TB patients were systematically offered HCV testing and those diagnosed with HCV, offered treatment with DAAs. Treatment monitoring was performed by TB staff in coordination with a hepatologist. The staff interviewed had a positive opinion of the new model. They suggested that additional training should be provided. Most patients were fully satisfied with the care received. Some were concerned about the increased pill burden.

CONCLUSION
Integrating HCV treatment into MDR/ RR-TB care was feasible and appreciated by patients and staff. This new model facilitated HCV diagnosis and treatment among people with MDR/RR-TB. Our results encourage piloting this model in other settings.