Journal Article > ResearchFull Text
Health Sci Rep. 30 March 2023; Volume 6 (Issue 4); e1165.; DOI:10.1002/hsr2.1165
Loarec A, Gutierrez AG, Muvale G, Couto AM, Nguyen AP, et al.
Health Sci Rep. 30 March 2023; Volume 6 (Issue 4); e1165.; DOI:10.1002/hsr2.1165
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
Health Sci Rep. 17 February 2023; Volume 6 (Issue 2); e1119.; DOI:doi.org/10.1002/hsr2.1119
Swe TM, Johnson DC, Mar HT, Thit P, Homan T, et al.
Health Sci Rep. 17 February 2023; Volume 6 (Issue 2); e1119.; DOI:doi.org/10.1002/hsr2.1119
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 > ResearchFull Text
AIDS. 16 November 2018; Volume 33 (Issue 2); DOI:10.1097/QAD.0000000000002070
Loarec A, Carnimeo V, Molfino L, Kizito W, Muyindike WR, et al.
AIDS. 16 November 2018; Volume 33 (Issue 2); DOI:10.1097/QAD.0000000000002070
: A multicentric, retrospective case-series analysis (facility-based) in five sites across Kenya, Malawi, Mozambique, and Uganda screened HIV-positive adults for hepatitis C virus (HCV) antibodies using Oraquick rapid testing and viral confirmation (in three sites). Results found substantially lower prevalence than previously reported for these countries compared with previous reports, suggesting that targeted integration of HCV screening in African HIV programs may be more impactful than routine screening.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.
Conference Material > Abstract
Arago M, Mangue M, Cumbi N, Zamudio AG, Loarec A, et al.
MSF Scientific Days International 2021: Innovation. 20 May 2021
WHAT CHALLENGE OR OPPORTUNITY DID YOU TRY TO ADDRESS? WERE EXISTING SOLUTIONS NOT AVAILABLE OR NOT GOOD ENOUGH?
Ototoxicity is an unfortunate side-effect of second-line injectable drugs for drug-resistant tuberculosis (DRTB), including aminoglycosides and peptides. Worldwide, up to 15% of patients on treatment regimens containing these drugs develop a degree of ototoxicity. Patients who experience ototoxicity are generally switched to an oral treatment regimen. Although regular audiological evaluations are recommended for patients receiving these drugs, there is limited access to these services, and few patients with noticeable hearing problems are referred for confirmation and follow-up.
WHY DOES THIS CHALLENGE OR OPPORTUNITY MATTER – WHY SHOULD MSF ADDRESS IT?
Before the introduction of this digital tool, the MSF DRTB project in Mozambique had to refer patients to the Central Hospital in Maputo. This limited the number of patients screened and referred for testing, curtailing the potential to switch treatment early for those showing mild-to-moderate hearing loss.
DESCRIBE YOUR INNOVATION AND WHAT MAKES IT INNOVATIVE
In 2018, the team piloted a way to simplify monitoring of hearing using a clinically approved mobile tablet-based tool that has been found to be comparable with traditional audiometry measurements in children and adults. MSF acquired three kits of CE-marked and FDA-certified iOS-based audiometry kits from SHOEBOX® Audiometry systems. The units were comprised of calibrated headphones and tablet-based software that have acceptable accuracy (±10dB) with 90% sensitivity and specificity. The portable units were deployed in rotation in six health centres over two years; a total of 673 audiometry tests were performed in MSF-supported public health centres in Maputo. Patients were tested at baseline during their first consultation and then monthly while on treatment regimens that included injectable drugs.
WHO WILL BENEFIT (WHOSE LIFE / WORK WILL IT IMPROVE?) AND WERE THEY INVOLVED IN THE DESIGN?
The 2018 Mozambique National TB Committee approved treatment without injectable drugs in patients who had any degree of hearing impairment before the initiation of treatment. Patients screened using the digital tool directly benefitted from switching to oral DRTB treatment if they exhibited any hearing loss, without requiring hospital referral.
WHAT OBJECTIVES DID YOU SET FOR THE PROJECT – WHAT DID YOU WANT TO ACHIEVE AND HOW DID YOU DEFINE AND MEASURE SUCCESS (IMPROVED SERVICE, LOWER COST, BETTER EFFICIENCY, BETTER USER EXPERIENCE, ETC.)?
We describe the implementation and use of a mobile audiometry system for patients with treatment-related ototoxicity in the MSF DRTB project in Mozambique, and consider its potential for easily assessing hearing deterioration in this cohort.
WHAT DATA DID YOU COLLECT TO MEASURE THE INNOVATION AGAINST THESE INDICATORS AND HOW DID YOU COLLECT IT? INCLUDE IF YOU DECIDED TO CHANGE THE INDICATORS AND WHY
Routinely collected data were evaluated.
WERE THERE ANY LIMITATIONS TO THE DATA YOU COLLECTED, HOW YOU COLLECTED IT OR HOW YOU ANALYSED IT, OR WERE THERE ANY UNFORESEEN FACTORS THAT MAY HAVE INTERFERED WITH YOUR RESULTS?
Data were analysed retrospectively from routine records and may not be exhaustive. Separate analysis of baseline and follow-up was not possible.
WHAT RESULTS DID YOU GET?
Of the 673 audiometry tests conducted using the digital tool, 480 (71%) showed normal hearing, 65 (10%) mild hearing loss, 81 (12%) moderate hearing loss, and 47 (7%) severe-to-profound hearing loss.
COMPARING THE RESULTS FROM YOUR DATA ANALYSIS TO YOUR OBJECTIVES, EXPLAIN WHY YOU CONSIDER YOUR INNOVATION A SUCCESS OR FAILURE?
This decentralised approach does not need specialised setup, which may lead to increased screening, proper follow-up, and more potential for early switching of drug regimens.
TO WHAT EXTENT DID THE INNOVATION BENEFIT PEOPLE’S LIVES / WORK?
Decreasing the need for hospital referrals improved time and transport costs for patients.
IS THERE ANYTHING THAT YOU WOULD DO DIFFERENTLY IF YOU WERE TO DO THE WORK AGAIN?:
A cost-benefit analysis to compare the mobile audiometry system to referrals would be beneficial for programmatic decisions.
WHAT ARE THE NEXT STEPS FOR THE INNOVATION ITSELF (SCALE UP, IMPLEMENTATION, FURTHER DEVELOPMENT, DISCONTINUED)?
In December 2019, the project was phased out as there was a protocol change in which injectable drugs were replaced with more potent and fully oral regimens that made monitoring for ototoxicity unnecessary for most patients.
IS THE INNOVATION TRANSFERABLE OR ADAPTABLE TO OTHER SETTINGS OR DOMAINS?
The tools adapted are clinically approved for screening activities for any programmes that deal with hearing loss.
WHAT BROADER IMPLICATIONS ARE THERE FROM THE INNOVATION FOR MSF AND / OR OTHERS (CHANGE IN PRACTICE, CHANGE IN POLICY, CHANGE IN GUIDELINES, PARADIGM SHIFT)?
The project demonstrates the potential to improve follow-up and detect complications early for patients who take ototoxic medications.
WHAT OTHER LEARNINGS FROM YOUR WORK ARE IMPORTANT TO SHARE?
User-friendly and automated audiometry systems that are mobile and do not require audiologists or sound-insulated booths could be extremely useful to various medical projects using potentially ototoxic drugs such as aminoglycosides. They may also be beneficial for environmental projects with noise and toxic pollutions. The high cost of the license could present a limitation necessitating a cost-benefit analysis before contemplating scale-up.
ETHICS
This description and evaluation of an innovation project involved human participants or their data, and has had ethics oversight from Monica Rull, Medical Director, Operational Centre Geneva, MSF.
Ototoxicity is an unfortunate side-effect of second-line injectable drugs for drug-resistant tuberculosis (DRTB), including aminoglycosides and peptides. Worldwide, up to 15% of patients on treatment regimens containing these drugs develop a degree of ototoxicity. Patients who experience ototoxicity are generally switched to an oral treatment regimen. Although regular audiological evaluations are recommended for patients receiving these drugs, there is limited access to these services, and few patients with noticeable hearing problems are referred for confirmation and follow-up.
WHY DOES THIS CHALLENGE OR OPPORTUNITY MATTER – WHY SHOULD MSF ADDRESS IT?
Before the introduction of this digital tool, the MSF DRTB project in Mozambique had to refer patients to the Central Hospital in Maputo. This limited the number of patients screened and referred for testing, curtailing the potential to switch treatment early for those showing mild-to-moderate hearing loss.
DESCRIBE YOUR INNOVATION AND WHAT MAKES IT INNOVATIVE
In 2018, the team piloted a way to simplify monitoring of hearing using a clinically approved mobile tablet-based tool that has been found to be comparable with traditional audiometry measurements in children and adults. MSF acquired three kits of CE-marked and FDA-certified iOS-based audiometry kits from SHOEBOX® Audiometry systems. The units were comprised of calibrated headphones and tablet-based software that have acceptable accuracy (±10dB) with 90% sensitivity and specificity. The portable units were deployed in rotation in six health centres over two years; a total of 673 audiometry tests were performed in MSF-supported public health centres in Maputo. Patients were tested at baseline during their first consultation and then monthly while on treatment regimens that included injectable drugs.
WHO WILL BENEFIT (WHOSE LIFE / WORK WILL IT IMPROVE?) AND WERE THEY INVOLVED IN THE DESIGN?
The 2018 Mozambique National TB Committee approved treatment without injectable drugs in patients who had any degree of hearing impairment before the initiation of treatment. Patients screened using the digital tool directly benefitted from switching to oral DRTB treatment if they exhibited any hearing loss, without requiring hospital referral.
WHAT OBJECTIVES DID YOU SET FOR THE PROJECT – WHAT DID YOU WANT TO ACHIEVE AND HOW DID YOU DEFINE AND MEASURE SUCCESS (IMPROVED SERVICE, LOWER COST, BETTER EFFICIENCY, BETTER USER EXPERIENCE, ETC.)?
We describe the implementation and use of a mobile audiometry system for patients with treatment-related ototoxicity in the MSF DRTB project in Mozambique, and consider its potential for easily assessing hearing deterioration in this cohort.
WHAT DATA DID YOU COLLECT TO MEASURE THE INNOVATION AGAINST THESE INDICATORS AND HOW DID YOU COLLECT IT? INCLUDE IF YOU DECIDED TO CHANGE THE INDICATORS AND WHY
Routinely collected data were evaluated.
WERE THERE ANY LIMITATIONS TO THE DATA YOU COLLECTED, HOW YOU COLLECTED IT OR HOW YOU ANALYSED IT, OR WERE THERE ANY UNFORESEEN FACTORS THAT MAY HAVE INTERFERED WITH YOUR RESULTS?
Data were analysed retrospectively from routine records and may not be exhaustive. Separate analysis of baseline and follow-up was not possible.
WHAT RESULTS DID YOU GET?
Of the 673 audiometry tests conducted using the digital tool, 480 (71%) showed normal hearing, 65 (10%) mild hearing loss, 81 (12%) moderate hearing loss, and 47 (7%) severe-to-profound hearing loss.
COMPARING THE RESULTS FROM YOUR DATA ANALYSIS TO YOUR OBJECTIVES, EXPLAIN WHY YOU CONSIDER YOUR INNOVATION A SUCCESS OR FAILURE?
This decentralised approach does not need specialised setup, which may lead to increased screening, proper follow-up, and more potential for early switching of drug regimens.
TO WHAT EXTENT DID THE INNOVATION BENEFIT PEOPLE’S LIVES / WORK?
Decreasing the need for hospital referrals improved time and transport costs for patients.
IS THERE ANYTHING THAT YOU WOULD DO DIFFERENTLY IF YOU WERE TO DO THE WORK AGAIN?:
A cost-benefit analysis to compare the mobile audiometry system to referrals would be beneficial for programmatic decisions.
WHAT ARE THE NEXT STEPS FOR THE INNOVATION ITSELF (SCALE UP, IMPLEMENTATION, FURTHER DEVELOPMENT, DISCONTINUED)?
In December 2019, the project was phased out as there was a protocol change in which injectable drugs were replaced with more potent and fully oral regimens that made monitoring for ototoxicity unnecessary for most patients.
IS THE INNOVATION TRANSFERABLE OR ADAPTABLE TO OTHER SETTINGS OR DOMAINS?
The tools adapted are clinically approved for screening activities for any programmes that deal with hearing loss.
WHAT BROADER IMPLICATIONS ARE THERE FROM THE INNOVATION FOR MSF AND / OR OTHERS (CHANGE IN PRACTICE, CHANGE IN POLICY, CHANGE IN GUIDELINES, PARADIGM SHIFT)?
The project demonstrates the potential to improve follow-up and detect complications early for patients who take ototoxic medications.
WHAT OTHER LEARNINGS FROM YOUR WORK ARE IMPORTANT TO SHARE?
User-friendly and automated audiometry systems that are mobile and do not require audiologists or sound-insulated booths could be extremely useful to various medical projects using potentially ototoxic drugs such as aminoglycosides. They may also be beneficial for environmental projects with noise and toxic pollutions. The high cost of the license could present a limitation necessitating a cost-benefit analysis before contemplating scale-up.
ETHICS
This description and evaluation of an innovation project involved human participants or their data, and has had ethics oversight from Monica Rull, Medical Director, Operational Centre Geneva, MSF.
Journal Article > ResearchFull Text
J Viral Hepat. 4 November 2020; Volume 28 (Issue 2); 268-278.; DOI:10.1111/jvh.13422
Mafirakureva N, Lim AG, Khalid GG, Aslam K, Campbell L, et al.
J Viral Hepat. 4 November 2020; Volume 28 (Issue 2); 268-278.; DOI:10.1111/jvh.13422
Despite the availability of effective direct-acting antiviral (DAA) treatments for Hepatitis C virus (HCV) infection, many people remain undiagnosed and untreated. We assessed the cost-effectiveness of a Médecins Sans Frontières (MSF) HCV screening and treatment programme within a primary health clinic in Karachi, Pakistan. A health state transition Markov model was developed to estimate the cost-effectiveness of the MSF programme. Programme cost and outcome data were analysed retrospectively. The incremental cost-effectiveness ratio (ICER) was calculated in terms of incremental cost (2016 US$) per disability-adjusted life year (DALY) averted from the provider's perspective over a lifetime horizon. The robustness of the model was evaluated using deterministic and probabilistic sensitivity analyses (PSA). The ICER for implementing testing and treatment compared to no programme was US$450/DALY averted, with 100% of PSA runs falling below the per capita Gross Domestic Product threshold for cost-effective interventions for Pakistan (US$1,422). The ICER increased to US$532/DALY averted assuming national HCV seroprevalence (5.5% versus 33% observed in the intervention). If the cost of liver disease care was included (adapted from resource use data from Cambodia which has similar GDP to Pakistan), the ICER dropped to US$148/DALY, while it became cost-saving if a recently negotiated reduced drug cost of $75/treatment course was assumed (versus $282 in base-case) in addition to cost of liver disease care. In conclusion, screening and DAA treatment for HCV infection are expected to be highly cost-effective in Pakistan, supporting the expansion of similar screening and treatment programmes across Pakistan.
Journal Article > ResearchFull Text
Liver Int. 31 May 2020; Volume 40 (Issue 10); 2356-2366.; DOI:10.1111/liv.14550
Walker JG, Mafirakureva N, Iwamoto M, Campbell L, Kim CS, et al.
Liver Int. 31 May 2020; Volume 40 (Issue 10); 2356-2366.; DOI:10.1111/liv.14550
BACKGROUND & AIMS
In 2016, Médecins Sans Frontières established the first general population Hepatitis C virus (HCV) screening and treatment site in Cambodia, offering free direct-acting antiviral (DAA) treatment. This study analysed the cost-effectiveness of this intervention.
METHODS
Costs, quality adjusted life years (QALYs) and cost-effectiveness of the intervention were projected with a Markov model over a lifetime horizon, discounted at 3%/year. Patient-level resource-use and outcome data, treatment costs, costs of HCV-related healthcare and EQ-5D-5L health states were collected from an observational cohort study evaluating the effectiveness of DAA treatment under full and simplified models of care compared to no treatment; other model parameters were derived from literature. Incremental cost-effectiveness ratios (cost/QALY gained) were compared to an opportunity cost-based willingness-to-pay threshold for Cambodia ($248/QALY).
RESULTS
The total cost of testing and treatment per patient for the full model of care was $925(IQR $668-1631), reducing to $376(IQR $344-422) for the simplified model of care. EQ-5D-5L values varied by fibrosis stage: decompensated cirrhosis had the lowest value, values increased during and following treatment. The simplified model of care was cost saving compared to no treatment, while the full model of care, although cost-effective compared to no treatment ($187/QALY), cost an additional $14 485/QALY compared to the simplified model, above the willingness-to-pay threshold for Cambodia. This result is robust to variation in parameters.
CONCLUSIONS
The simplified model of care was cost saving compared to no treatment, emphasizing the importance of simplifying pathways of care for improving access to HCV treatment in low-resource settings.
In 2016, Médecins Sans Frontières established the first general population Hepatitis C virus (HCV) screening and treatment site in Cambodia, offering free direct-acting antiviral (DAA) treatment. This study analysed the cost-effectiveness of this intervention.
METHODS
Costs, quality adjusted life years (QALYs) and cost-effectiveness of the intervention were projected with a Markov model over a lifetime horizon, discounted at 3%/year. Patient-level resource-use and outcome data, treatment costs, costs of HCV-related healthcare and EQ-5D-5L health states were collected from an observational cohort study evaluating the effectiveness of DAA treatment under full and simplified models of care compared to no treatment; other model parameters were derived from literature. Incremental cost-effectiveness ratios (cost/QALY gained) were compared to an opportunity cost-based willingness-to-pay threshold for Cambodia ($248/QALY).
RESULTS
The total cost of testing and treatment per patient for the full model of care was $925(IQR $668-1631), reducing to $376(IQR $344-422) for the simplified model of care. EQ-5D-5L values varied by fibrosis stage: decompensated cirrhosis had the lowest value, values increased during and following treatment. The simplified model of care was cost saving compared to no treatment, while the full model of care, although cost-effective compared to no treatment ($187/QALY), cost an additional $14 485/QALY compared to the simplified model, above the willingness-to-pay threshold for Cambodia. This result is robust to variation in parameters.
CONCLUSIONS
The simplified model of care was cost saving compared to no treatment, emphasizing the importance of simplifying pathways of care for improving access to HCV treatment in low-resource settings.
Journal Article > ResearchFull Text
J Hepatol. 21 February 2019; Volume 71 (Issue 1); 62-70.; DOI:https://doi.org/10.1016/j.jhep.2019.02.011
Freiman JM, Wang J, Easterbrook PJ, Horsburgh CR, Marinucci F, et al.
J Hepatol. 21 February 2019; Volume 71 (Issue 1); 62-70.; DOI:https://doi.org/10.1016/j.jhep.2019.02.011
BACKGROUND & AIMS
Affordable point-of-care tests for hepatitis C (HCV) viraemia are needed to improve access to treatment in low- and middle-income countries. Our aims were to determine the target limit of detection (LOD) necessary to diagnose the majority of people with HCV eligible for treatment, and identify characteristics associated with low-level viraemia (LLV) (defined as the lowest 3% of the distribution of HCV RNA) to understand those at risk of being misdiagnosed.
METHODS
We established a multi-country cross-sectional dataset of first available quantitative HCV RNA measurements linked to demographic and clinical data. We excluded individuals on HCV treatment. We analysed the distribution of HCV RNA and determined critical thresholds for detection of HCV viraemia. We then performed logistic regression to evaluate factors associated with LLV, and derived relative sensitivities for significant covariates.
RESULTS
The dataset included 66,640 individuals with HCV viraemia from across the world. The LOD for the 95th and 99th percentiles were 3,311 IU/ml and 214 IU/ml. The LOD for the 97th percentile was 1,318 IU/ml (95% CI 1,298.4–1,322.3). Factors associated with LLV, defined as HCV RNA <1,318 IU/ml, were younger age 18–30 vs. 51–64 years (odds ratios [OR] 2.56; 95% CI 2.19–2.99), female vs. male sex (OR 1.32; 95% CI 1.18–1.49), and advanced fibrosis stage F4 vs. F0-1 (OR 1.44; 95% CI 1.21–1.69). Only the younger age group had a decreased relative sensitivity below 95%, at 93.3%.
CONCLUSIONS
In this global dataset, a test with an LOD of 1,318 IU/ml would identify 97% of viraemic HCV infections among almost all populations. This LOD will help guide manufacturers in the development of affordable point-of-care diagnostics to expand HCV testing and linkage to care in low- and middle-income countries.
LAY SUMMARY
We created and analysed a dataset from 12 countries with 66,640 participants with chronic hepatitis C virus infection. We determined that about 97% of those with viraemic infection had 1,300 IU/ml or more of circulating virus at the time of diagnosis. While current diagnostic tests can detect as little as 12 IU/ml of virus, our findings suggest that increasing the level of detection closer to 1,300 IU/ml would maintain good test accuracy and will likely enable development of more affordable portable tests for use in low- and middle-income countries.
Affordable point-of-care tests for hepatitis C (HCV) viraemia are needed to improve access to treatment in low- and middle-income countries. Our aims were to determine the target limit of detection (LOD) necessary to diagnose the majority of people with HCV eligible for treatment, and identify characteristics associated with low-level viraemia (LLV) (defined as the lowest 3% of the distribution of HCV RNA) to understand those at risk of being misdiagnosed.
METHODS
We established a multi-country cross-sectional dataset of first available quantitative HCV RNA measurements linked to demographic and clinical data. We excluded individuals on HCV treatment. We analysed the distribution of HCV RNA and determined critical thresholds for detection of HCV viraemia. We then performed logistic regression to evaluate factors associated with LLV, and derived relative sensitivities for significant covariates.
RESULTS
The dataset included 66,640 individuals with HCV viraemia from across the world. The LOD for the 95th and 99th percentiles were 3,311 IU/ml and 214 IU/ml. The LOD for the 97th percentile was 1,318 IU/ml (95% CI 1,298.4–1,322.3). Factors associated with LLV, defined as HCV RNA <1,318 IU/ml, were younger age 18–30 vs. 51–64 years (odds ratios [OR] 2.56; 95% CI 2.19–2.99), female vs. male sex (OR 1.32; 95% CI 1.18–1.49), and advanced fibrosis stage F4 vs. F0-1 (OR 1.44; 95% CI 1.21–1.69). Only the younger age group had a decreased relative sensitivity below 95%, at 93.3%.
CONCLUSIONS
In this global dataset, a test with an LOD of 1,318 IU/ml would identify 97% of viraemic HCV infections among almost all populations. This LOD will help guide manufacturers in the development of affordable point-of-care diagnostics to expand HCV testing and linkage to care in low- and middle-income countries.
LAY SUMMARY
We created and analysed a dataset from 12 countries with 66,640 participants with chronic hepatitis C virus infection. We determined that about 97% of those with viraemic infection had 1,300 IU/ml or more of circulating virus at the time of diagnosis. While current diagnostic tests can detect as little as 12 IU/ml of virus, our findings suggest that increasing the level of detection closer to 1,300 IU/ml would maintain good test accuracy and will likely enable development of more affordable portable tests for use in low- and middle-income countries.
Conference Material > Poster
Antabak NT, Loarec A, Nguyen AP, Eliseo NDM, Molfino L, et al.
MSF Scientific Days UK 2018: Research. 4 May 2018; DOI:10.7490/f1000research.1115424.1
Journal Article > ResearchAbstract Only
Int J Drug Policy. 1 April 2021; Volume 90; 103095.; DOI:10.1016/j.drugpo.2020.103095
Sema Baltazar C, Kellogg TA, Boothe M, Loarec A, de Abreu E, et al.
Int J Drug Policy. 1 April 2021; Volume 90; 103095.; DOI:10.1016/j.drugpo.2020.103095
BACKGROUND
People who use drugs (PWUD) which includes both people who inject drugs (PWID) and non-injection drug users (NIDU) are marginalized, experience high levels of stigma and discrimination, and are likely to have challenges with accessing health services. Mozambique implemented the first drop-in center (DIC) for PWUD in Maputo City in 2018. This analysis aims to assess the prevalence of HIV, viral hepatitis B (HBV) and C (HCV) and tuberculosis (TB) among PWUD, and assess their linkage to care and associated correlates.
METHODS
We conducted a cross-sectional retrospective analysis of routine screening data collected from the first visit at the drop-in center (DIC) during the period of May 2018 to November 2019 (18 months). Descriptive and multivariable logistic regression analysis were conducted to estimate adjusted odds ratios (aOR) and 95% confidence intervals (CI) of HIV, HBV, HCV and TB infections among PWID and NIDU. Cox proportional hazards models of determinants were used to estimate time from HIV diagnosis to linkage to care for PWUD.
RESULTS
A total of 1,818 PWUD were screened at the DIC, of whom 92.6% were male. The median age was 27 years (range:14–63). Heroin was the most consumed drug (93.8%), and among people who used it, 15.5% injected it. Prevalence of HIV (43.9%), HCV (22.6%) and HBV (5.9%) was higher among PWID (p<0.001). Linkage to HIV care was observed in 40.5% of newly diagnosed PWID. Factors associated with shorter time to linkage to care included drug injection (aHR=1.6) and confirmed TB infection (aHR=2.9).
CONCLUSION
This was the first analysis conducted on the implementation of the DIC in Mozambique and highlights the importance of targeted services for this high-risk population. Our analysis confirmed a high prevalence of HIV, HBV and HCV, and highlight the challenges with linkage to care among PWID. The expansion of DIC locations to other high-risk localities to enhance HIV testing, treatment services and linkage to care to reduce ongoing transmission of HIV, HBV, HCV and TB and improve health outcomes.
People who use drugs (PWUD) which includes both people who inject drugs (PWID) and non-injection drug users (NIDU) are marginalized, experience high levels of stigma and discrimination, and are likely to have challenges with accessing health services. Mozambique implemented the first drop-in center (DIC) for PWUD in Maputo City in 2018. This analysis aims to assess the prevalence of HIV, viral hepatitis B (HBV) and C (HCV) and tuberculosis (TB) among PWUD, and assess their linkage to care and associated correlates.
METHODS
We conducted a cross-sectional retrospective analysis of routine screening data collected from the first visit at the drop-in center (DIC) during the period of May 2018 to November 2019 (18 months). Descriptive and multivariable logistic regression analysis were conducted to estimate adjusted odds ratios (aOR) and 95% confidence intervals (CI) of HIV, HBV, HCV and TB infections among PWID and NIDU. Cox proportional hazards models of determinants were used to estimate time from HIV diagnosis to linkage to care for PWUD.
RESULTS
A total of 1,818 PWUD were screened at the DIC, of whom 92.6% were male. The median age was 27 years (range:14–63). Heroin was the most consumed drug (93.8%), and among people who used it, 15.5% injected it. Prevalence of HIV (43.9%), HCV (22.6%) and HBV (5.9%) was higher among PWID (p<0.001). Linkage to HIV care was observed in 40.5% of newly diagnosed PWID. Factors associated with shorter time to linkage to care included drug injection (aHR=1.6) and confirmed TB infection (aHR=2.9).
CONCLUSION
This was the first analysis conducted on the implementation of the DIC in Mozambique and highlights the importance of targeted services for this high-risk population. Our analysis confirmed a high prevalence of HIV, HBV and HCV, and highlight the challenges with linkage to care among PWID. The expansion of DIC locations to other high-risk localities to enhance HIV testing, treatment services and linkage to care to reduce ongoing transmission of HIV, HBV, HCV and TB and improve health outcomes.
Conference Material > Slide Presentation
Arago M, Mangue M, Cumbi N, Zamudio AG, Loarec A, et al.
MSF Scientific Days International 2021: Innovation. 20 May 2021