Viral hepatitis is a major cause of disease and death globally. To mark World Hepatitis Day (July 28th) we present a selection of recent MSF research exploring how to effectively deploy powerful medical tools that could turn the tide on hepatitis C and E—but now reach only a tiny fraction of people who desperately need them, especially in low-resource and emergency settings.
For hepatitis C, where groundbreaking new antiviral drugs can cure nearly all patients, MSF is piloting simplified, community-based models of care that offer rapid screening, diagnosis, and treatment under one roof. Some programs focus on the complex needs of highly vulnerable, hard-to-reach populations, such as people co-infected with HIV or TB or who inject drugs.
Turning to prevention, an ongoing vaccination campaign against hepatitis E in an outbreak setting is showing early signs of short-term protection. Final results from this South Sudanese refugee camp, where poor sanitation and water quality regularly lead to outbreaks, should help plug a key evidence gap that—along with other barriers discussed in a commentary article—impedes widespread uptake of the vaccine.
8 result(s)
Conference Material > Abstract
Nesbitt RC
Epicentre Scientific Day Paris 2023. 2023 June 8
BACKGROUND
Hepatitis E causes high mortality among pregnant women with case fatality risks of 10-25%, and adverse fetal outcomes. Hecolin® is a safe and efficacious vaccine against Hepatitis E, but there is an evidence gap on its safety in pregnant women. In 2015 the WHO recommended its use in response to outbreaks, including vaccinating pregnant women. The first mass reactive vaccination campaign against Hepatitis E was conducted in Bentiu including pregnant women and achieved high administrative vaccination coverage. We aimed to document pregnancy outcomes in a cohort of vaccinated and non-vaccinated pregnant women.
METHODS
An exhaustive pregnancy census was conducted after the second vaccination round from 16 May to 30 June 2022 to recruit women who were pregnant between 1 January 2022 and the interview date. Women were recontacted a minimum of 28 days after expected delivery to assess pregnancy outcome. Categorization of the cohort according to timing of potential vaccine exposure in pregnancy and regression models to evaluate the association between at least one dose in pregnancy and pregnancy outcomes is ongoing.
RESULTS
Of 20,674 women of childbearing age who consented for interview, 3,458 (16.7%) reported being pregnant since 1 January 2022. Women were a mean of 25.5 years old, had a median of 2 previous pregnancies (0-11), and 21 (0.6%) reported experiencing jaundice during their current pregnancy. Overall, 2723 (78.7%) women received at least one dose of Hecolin®. Access to delivery care was high, with 90% of women delivering in a health facility; 357 (10.3%) women reported a complication during delivery and 16 (0.5%) reported a caesarean section. According to interview, 3233 (93.5%) women had a livebirth, and 225 (6.9%) had a pregnancy loss, including 57 (1.6%) reported stillbirths, translating to a stillbirth rate of 17.6/1000 pregnancies, compared to the national estimate of 25.8/1000 pregnancies.
CONCLUSION
It was feasible to implement an observational study on the safety of vaccination in pregnancy alongside the first deployment of Hecolin® in a humanitarian emergency setting. Access to delivery care is reflected in the lower than national average rate of stillbirth in the camp. Results are expected to narrow the evidence gap on the safety of this vaccine in pregnancy.
KEY MESSAGE
A cohort study on the safety of vaccination in pregnancy was implemented alongside the first deployment of Hecolin® in a humanitarian emergency setting. Preliminary results show overall high coverage with at least one dose and access to delivery care among women in the cohort
This abstract is not to be quoted for publication.
Hepatitis E causes high mortality among pregnant women with case fatality risks of 10-25%, and adverse fetal outcomes. Hecolin® is a safe and efficacious vaccine against Hepatitis E, but there is an evidence gap on its safety in pregnant women. In 2015 the WHO recommended its use in response to outbreaks, including vaccinating pregnant women. The first mass reactive vaccination campaign against Hepatitis E was conducted in Bentiu including pregnant women and achieved high administrative vaccination coverage. We aimed to document pregnancy outcomes in a cohort of vaccinated and non-vaccinated pregnant women.
METHODS
An exhaustive pregnancy census was conducted after the second vaccination round from 16 May to 30 June 2022 to recruit women who were pregnant between 1 January 2022 and the interview date. Women were recontacted a minimum of 28 days after expected delivery to assess pregnancy outcome. Categorization of the cohort according to timing of potential vaccine exposure in pregnancy and regression models to evaluate the association between at least one dose in pregnancy and pregnancy outcomes is ongoing.
RESULTS
Of 20,674 women of childbearing age who consented for interview, 3,458 (16.7%) reported being pregnant since 1 January 2022. Women were a mean of 25.5 years old, had a median of 2 previous pregnancies (0-11), and 21 (0.6%) reported experiencing jaundice during their current pregnancy. Overall, 2723 (78.7%) women received at least one dose of Hecolin®. Access to delivery care was high, with 90% of women delivering in a health facility; 357 (10.3%) women reported a complication during delivery and 16 (0.5%) reported a caesarean section. According to interview, 3233 (93.5%) women had a livebirth, and 225 (6.9%) had a pregnancy loss, including 57 (1.6%) reported stillbirths, translating to a stillbirth rate of 17.6/1000 pregnancies, compared to the national estimate of 25.8/1000 pregnancies.
CONCLUSION
It was feasible to implement an observational study on the safety of vaccination in pregnancy alongside the first deployment of Hecolin® in a humanitarian emergency setting. Access to delivery care is reflected in the lower than national average rate of stillbirth in the camp. Results are expected to narrow the evidence gap on the safety of this vaccine in pregnancy.
KEY MESSAGE
A cohort study on the safety of vaccination in pregnancy was implemented alongside the first deployment of Hecolin® in a humanitarian emergency setting. Preliminary results show overall high coverage with at least one dose and access to delivery care among women in the cohort
This abstract is not to be quoted for publication.
Conference Material > Slide Presentation
Nesbitt RC, Rumunu J, Asilaza VK, Gitahi P, Nkemenang P, et al.
MSF Scientific Days International 2023. 2023 June 7
Journal Article > ResearchFull Text
Bull World Health Organ. 2023 April 1; Volume 101 (Issue 04); 262-270.
O’Keefe D, Samley K, Bunreth V, Marquardt T, Bobi 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.
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
Health Sci Rep. 2023 March 30; Volume 6 (Issue 4); e1165.
Loarec A, Gutierrez AG, Muvale G, Couto AM, Nguyen AP, et al.
Health Sci Rep. 2023 March 30; Volume 6 (Issue 4); e1165.
BACKGROUND AND AIMS
Hepatitis C (HCV) programs face challenges, especially linked to key populations to achieve World Health Organization (WHO) goals of eliminating hepatitis. Médecins Sans Frontières and Mozambique's Ministry of Health first implemented HCV treatment in Maputo, in 2016 and harm reduction activities in 2017.
METHODS
We retrospectively analyzed routine data of patients enrolled between December 2016 and July 2021. Genotyping was systematically requested up to 2018 and subsequently in cases of treatment failure. Sustainable virological response was assessed 12 weeks after the end of treatment by sofosbuvir-daclatasvir or sofosbuvir-velpatasvir.
RESULTS
Two hundred and two patients were enrolled, with 159 (78.71%) males (median age: 41 years [interquartile range (IQR): 37.10, 47.00]). Risk factors included drug use (142/202; 70.29%). One hundred and eleven genotyping results indicated genotype 1 predominant (87/111; 78.37%). Sixteen patients presented genotype 4, with various subtypes. The people who used drugs and HIV coinfected patients were found more likely to present a genotype 1. Intention-to-treat analysis showed 68.99% (89/129) cure rate among the patients initiated and per-protocol analysis, 88.12% (89/101) cure rate. Nineteen patients received treatment integrated with opioid substitution therapy, with a 100% cure rate versus 59.37% (38/64) for initiated ones without substitution therapy (p < 0.001). Among the resistance testing performed, NS5A resistance-associated substitutions were found in seven patients among the nine tested patients and NS5B ones in one patient.
CONCLUSION
We found varied genotypes, including some identified as difficult-to-treat subtypes. People who used drugs were more likely to present genotype 1. In addition, opioid substitution therapy was key for these patients to achieve cure. Access to second-generation direct-acting antivirals (DAAs) and integration of HCV care with harm reduction are crucial to program effectiveness.
Hepatitis C (HCV) programs face challenges, especially linked to key populations to achieve World Health Organization (WHO) goals of eliminating hepatitis. Médecins Sans Frontières and Mozambique's Ministry of Health first implemented HCV treatment in Maputo, in 2016 and harm reduction activities in 2017.
METHODS
We retrospectively analyzed routine data of patients enrolled between December 2016 and July 2021. Genotyping was systematically requested up to 2018 and subsequently in cases of treatment failure. Sustainable virological response was assessed 12 weeks after the end of treatment by sofosbuvir-daclatasvir or sofosbuvir-velpatasvir.
RESULTS
Two hundred and two patients were enrolled, with 159 (78.71%) males (median age: 41 years [interquartile range (IQR): 37.10, 47.00]). Risk factors included drug use (142/202; 70.29%). One hundred and eleven genotyping results indicated genotype 1 predominant (87/111; 78.37%). Sixteen patients presented genotype 4, with various subtypes. The people who used drugs and HIV coinfected patients were found more likely to present a genotype 1. Intention-to-treat analysis showed 68.99% (89/129) cure rate among the patients initiated and per-protocol analysis, 88.12% (89/101) cure rate. Nineteen patients received treatment integrated with opioid substitution therapy, with a 100% cure rate versus 59.37% (38/64) for initiated ones without substitution therapy (p < 0.001). Among the resistance testing performed, NS5A resistance-associated substitutions were found in seven patients among the nine tested patients and NS5B ones in one patient.
CONCLUSION
We found varied genotypes, including some identified as difficult-to-treat subtypes. People who used drugs were more likely to present genotype 1. In addition, opioid substitution therapy was key for these patients to achieve cure. Access to second-generation direct-acting antivirals (DAAs) and integration of HCV care with harm reduction are crucial to program effectiveness.
Journal Article > ResearchFull Text
Harm Reduct J. 2023 March 4; Volume 20 (Issue 1); 27.
Saayman E, Hechter V, Kayuni N, Sonderup 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.
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 TM, Johnson DC, Mar HT, Thit P, Homan 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.
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 JA, Lim JK, Asaga PEP, Wartel TA, Marti 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 O, Melikyan N, Falcao J, Khachatryan N, Atshemyan 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.
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.
