Data Sources and Methodology

Data Sources and Methodology

Technical notes

HBV-related deaths

Description: Estimated number of HBV-related deaths for all ages, both sexes in 2017. The 95% confidence interval for this estimate is presented.

HBV-related deaths include deaths due to acute HBV, cirrhosis and other chronic liver diseases attributable to HBV, and liver cancer attributable to HBV.

Source: Institute for Health Metrics and Evaluation. Global Burden of Disease Project, 2017. 

This data can be accessed at: http://ghdx.healthdata.org/gbd-results-tool. Input data sources to the Global Burden of Disease project can be accessed here: http://ghdx.healthdata.org/gbd-2017/data-input-sources.

Note in country dashboards with two death rates, as described below, the indicator on number of HBV-related deaths was omitted.

 HBV-related death rate:

Source 1:

All country data dashboards show the estimated HBV death rate from the Institute of Health Metrics and Evaluation.

Description of indicator: Estimated HBV-related death rate per 100,000 population for all ages, both sexes in 2017.  

HBV-related deaths include deaths due to acute HBV, cirrhosis and other chronic liver diseases attributable to HBV, and liver cancer attributable to HBV.

 Source: Institute for Health Metrics and Evaluation. Global Burden of Disease Project, 2017. 

This data can be accessed at: http://ghdx.healthdata.org/gbd-results-tool. Input data sources to the Global Burden of Disease project can be accessed here: http://ghdx.healthdata.org/gbd-2017/data-input-sources.

Source 2:

Select countries may have a second reported death rate that is sourced from published national data sources. In the case of two death rates, the one from national data sources can be identified by information in the indicator title on the dashboard. For example, on the United States page, the HBV-death rate title reads:” per 100,000 HBV-related deaths 2016, National Vital Registry, US CDC.” These death rates are generally based on death records or other national surveillance systems.

This national data was either provided by local program managers or was identified by CGHE staff through a web-based search. CGHE would be happy to add nationally sourced death rates for additional countries. Please contact: globalhep [at] taskforce.org () to share any data.

Examples of national data sources include:

Centers for Disease Control. Viral Hepatitis Surveillance United States, 2016. Available at : https://www.cdc.gov/hepatitis/statistics/2016surveillance/pdfs/2016HepSurveillanceRpt.pdf

These country resources can be accessed on their respective country pages as well.

Comparing Source 1 and Source 2 HBV-related death rates:

In some cases, the death rates shown from IHME and the one published by the country may be different.These differences could be due to differences in methodology.

The IHME death-rate is an estimated value that incorporates methods to adjust for incomplete or missing vital registration (VR) and verbal autopsy (VA) data, general heterogeneity in data completeness and quality, and the redistribution of unclassifiable death codes. More information on this approach is available in the annex of the GBD 2017 mortality estimation paper: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32203-7/fulltext (GBD Cause of Death 2017 Collaborators. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980–2017: a systematic analysis for the Global Burden of Disease Study 2017).

Country-reported data may follow other guidelines. For example, the US-reported number adjusted for under-ascertainment and under-reporting based on methods described in this paper: https://www.ncbi.nlm.nih.gov/pubmed/24432918 (Klevens RM et al. Estimating acute viral hepatitis infections from nationally reported cases. Am J Public Health. 2014 Mar;104(3):482-7).

For population denominators, IHME also used a set of modelling tools, including the GBD Cause of Death Ensemble model (CODEm), to generate cause fractions and cause-specific death rates for each location, year, age, and sex.  GBD 2017 independently estimated population size and fertility rate for all locations.  The nationally reported death rate may have a more country-specific approach. The death-rate for the US was computed by applying age-specific death rates to the U.S. standard population (relative age distribution of year 2000 (census) with population projections) (Centers for Disease Control. Viral Hepatitis Surveillance United States, 2016. Available at : https://www.cdc.gov/hepatitis/statistics/2016surveillance/pdfs/2016HepSurveillanceRpt.pdf

Liver cancer deaths attributable to HBV:

Description: Estimated percent of all-cause liver cancer deaths attributable to HBV for all ages, both sexes in 2017.

Source: Institute for Health Metrics and Evaluation. Global Burden of Disease Project, 2017.

This data can be accessed at: http://ghdx.healthdata.org/gbd-results-tool. Input data sources to the Global Burden of Disease project can be accessed here: http://ghdx.healthdata.org/gbd-2017/data-input-sources.

HCV-related deaths

Description: Estimated number of HCV-related deaths for all ages, both sexes in 2017. The 95% confidence interval for this estimate is presented.

HCV-related deaths include deaths due to acute HCV, cirrhosis and other chronic liver diseases attributable to HCV, and liver cancer attributable to HCV.

This data can be accessed at: http://ghdx.healthdata.org/gbd-results-tool. Input data sources to the Global Burden of Disease project can be accessed here: http://ghdx.healthdata.org/gbd-2017/data-input-sources.

Note in countries with two death rates, as described below, the indicator on number of HCV-related deaths was omitted.

 HCV-related death rate

Source 1:

All country data dashboards show the estimated HCV death rate from the Institute of Health Metrics and Evaluation.

Description of indicator: Estimated HCV-related death rate per 100,000 population for all ages, both sexes in 2017. 

HCV-related deaths include deaths due to acute HBV, cirrhosis and other chronic liver diseases attributable to HBV, and liver cancer attributable to HBV.

Source: Institute for Health Metrics and Evaluation. Global Burden of Disease Project, 2017. 

This data can be accessed at: http://ghdx.healthdata.org/gbd-results-tool. Input data sources to the Global Burden of Disease project can be accessed here: http://ghdx.healthdata.org/gbd-2017/data-input-sources.

Source 2:

Select countries may have a second reported death rate that is sourced from published national data sources. In the case of two death rates, the one from national data sources can be identified by information in the indicator title on the dashboard. For example, on the United States page, the HBV-death rate title reads:” per 100,000 HBV-related deaths 2016, National Vital Registry, US CDC.” These death rates are generally based on death records or other national surveillance systems.

This national data was either provided by local program managers or was identified by CGHE staff through a web-based search. CGHE would be happy to add nationally sourced death rates for additional countries. Please contact: globalhep [at] taskforce.org () to share any data.

Examples of national data sources include:

Centers for Disease Control. Viral Hepatitis Surveillance United States, 2016. Available at : https://www.cdc.gov/hepatitis/statistics/2016surveillance/pdfs/2016HepSurveillanceRpt.pdf

These country resources can be accessed on their respective country pages as well.

Comparing Source 1 and Source 2 HBV-related death rates:

In some cases, the death rates shown from IHME and the one reported by the country may be different. These differences could be due to differences in methodology.

The IHME death-rate is an estimated value that incorporates methods to adjust for incomplete or missing vital registration (VR) and verbal autopsy (VA) data, general heterogeneity in data completeness and quality, and the redistribution of unclassifiable death codes. More information on this approach is available in the annex of the GBD 2017 mortality estimation paper: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32203-7/fulltext (GBD Cause of Death 2017 Collaborators. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980–2017: a systematic analysis for the Global Burden of Disease Study 2017).

Country-reported data may follow other guidelines. For example, the US-reported number adjusted for under-ascertainment and under-reporting based on methods described in this paper: https://www.ncbi.nlm.nih.gov/pubmed/24432918 (Klevens RM et al. Estimating acute viral hepatitis infections from nationally reported cases. Am J Public Health. 2014 Mar;104(3):482-7).

For population denominators, GBD 2017 independently estimated population size and fertility rate for all locations.  The nationally reported death rate was likely based on government standard reporting protocols. The death-rate for the US was computed by applying age-specific death rates to the U.S. standard population (relative age distribution of year 2000 (census) with population projections) (Centers for Disease Control. Viral Hepatitis Surveillance United States, 2016. Available at : https://www.cdc.gov/hepatitis/statistics/2016surveillance/pdfs/2016HepSurveillanceRpt.pdf

Liver cancer deaths attributable to HCV:

Description: Estimated percent of all-cause liver cancer deaths attributable to HCV for all ages, both sexes in 2017.

Source: Institute for Health Metrics and Evaluation. Global Burden of Disease Project, 2017. This data can be accessed at: http://ghdx.healthdata.org/gbd-results-tool

This data can be accessed at: http://ghdx.healthdata.org/gbd-results-tool. Input data sources to the Global Burden of Disease project can be accessed here: http://ghdx.healthdata.org/gbd-2017/data-input-sources.

Hepatitis B birth dose vaccination coverage:

Description:

Reported percent of newborns who received hepatitis B vaccine in 2018.

Data was extracted from the WHO Vaccine-Preventable Diseases Monitoring System Database. This data was derived from official reports and in the majority of cases was reported as part of the WHO/UNICEF joint reporting process.

Source:

World Health Organization (2019). Vaccine-preventable diseases: Monitoring system 2019 global summary, reported estimates of HepB_BD coverage. Accessed July 15, 2019. Available at : http://apps.who.int/immunization_monitoring/globalsummary/timeseries/tscoveragehepb_bd.. html

Eligible for HBV generic medications:

Description:

This country is eligible for HBV generic medications under a license agreement between Gilead Sciences and Medicines Patent Pool (MPP). In July 2014, the MPP signed a licensing agreement with Gilead Sciences for tenofovir alafenamide (TAF). The TAF license broadened the MPP’s collaboration with Gilead and the parties’ earlier licence for the production of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), cobicistat (COBI), and elvitegravir (EVG).for tenofovir disoproxil fumarate (TDF). The agreement allows MPP to issue sublicences to generic manufacturers based in China, India and South Africa. Generic manufacturers can then sell TAF in 116 countries and territories, including this country.

This eligibility status does not indicate these products have been registered or are accessible in the country. Registration status and access will vary on a country-by-country basis. More information on registration status can be found at: https://medicinespatentpool.org/what-we-do/global-licence-overview/update-on-progress-of-mpp-sublicensees/.

Gilead’s tenofovir (TDF) patent expired in 2017. TAF is a modified compound that has been associated with fewer side effects and better outcomes when used in combination.

Source: Medicines Patent Pool. MedsPaL Database. Last accessed July 11, 2019. Available at:

https://www.medspal.org/?product_standardized_name%5B%5D=Tenofovir+150+mg&page=1

Eligible for HCV generic medications:

Description: This country is eligible for HCV generic medications as a result of being included in one of the following licensing agreements. Note that it is possible that the country may not be eligible for the full set of existing license agreements described. The country lists for each agreement are provided below.

1) Sofosbuvir (SOF) and SOF-based regimens: Bilateral, non-exclusive licenses were granted by Gilead to generic manufacturers on SOF, SOF/ledipasvir (LDV), SOF/velpatasvir (VEL), SOF/VEL/voxilaprevir (VOX) compounds. These select generic manufacturers can then sell these products in 105 countries and territories.

Full country eligibility list is available at: [INSERT LINK]

2) Daclatasvir (DAC) and SOF/DAC: A MPP license agreement with Bristol-Myers Squibb was signed in 2015 for Daclatasvir (DAC). This agreement grants generic manufacturers permission to sell generic DAC and DAC/SOF combinations in 112 countries and in other countries where there is no patent infringement.

Full country eligibility list is available at: [INSERT LINK]

For more information on the MPP-BMS agreement, please visit: https://medicinespatentpool.org/licence-post/daclatasvir-dcv/.

3) Glecaprevir/pibrentasvir (G/P):  In 2018, the MPP signed a royalty-free license agreement with AbbVie for G/P, a pangenotypic combination drug to cure HCV. The license enables quality-assured manufacturers to develop and sell generic medicines containing G/P in 96 low- and middle-income countries (LMICs) at affordable prices, enabling access to and treatment scale-up with the most effective pan-genotypic regimens.

For more information on the MPP-AbbVie agreement, please visit: https://medicinespatentpool.org/licence-post/glecaprevirpibrentasvir-gp/.

For more information on registration and approval of medications by WHO, please visit: https://medicinespatentpool.org/what-we-do/global-licence-overview/update-on-progress-of-mpp-sublicensees/.

Source: Medicines Patent Pool. MedsPaL Database. Last accessed July 11, 2019. Available at: https://www.medspal.org/?product_standardized_name%5B%5D=Sofosbuvir+400+mg&page=1

Countries eligible for generic sofosbuvir (SOF) and SOF-based regimens under Gilead-bilateral voluntary licenses:

Afghanistan, Algeria, Angola, Antigua and Barbuda, Armenia, Bangladesh, Belarus, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Congo, Democratic Republic of the, Cook Islands, Côte d’Ivoire, Cuba, Djibouti, Dominica, Egypt, El Salvador, Equatorial Guinea, Eritrea, Eswatini (formerly Swaziland), Ethiopia, Fiji, Gabon, Gambia, Ghana, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Kazakhstan, Kenya, Kiribati, Korea, DPR of, Kyrgyz Republic, Lao PDR, Lesotho, Liberia, Libya, Madagascar, Malawi, Malaysia, Maldives, Mali, Marshal Islands, Mauritania, Mauritius, Micronesia, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palau, Papua New Guinea, Paraguay, Philippines, Rwanda, Saint Vincent and the Grenadines, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Suriname, Tajikistan, Tanzania, United Republic of, Thailand, Timor–Leste, Togo, Tonga, Tunisia, Turkmenistan, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, Zambia, Zimbabwe

Source: Medicines Patent Pool. MedsPaL Database. Last accessed July 11, 2019. Available at: https://www.medspal.org/?product_standardized_name%5B%5D=Sofosbuvir+400+mg&page=1

Countries eligible for generic daclatasvir (DAC) and SOF/DAC combinations under BMS-MPP agreement:

Afghanistan, Algeria, Angola, Azerbaijan, Bangladesh, Belize, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Cook Islands, Costa Rica, Côte d’Ivoire, Cuba, Democratic Republic of the Congo, Djibouti, Dominica, Dominican Republic, Ecuador, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Gambia, Georgia, Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Iraq, Jamaica, Kenya, Kiribati, Korea Dem. Republic, Laos, Lesotho, Liberia, Libya, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Nicaragua, Niger, Nigeria, Niue, Pakistan, Palau, Panama, Papua New Guinea, Paraguay, Philippines, Republic of the Congo, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, St Lucia, St. Vincent and the Grenadines, Sudan, Suriname, Swaziland, Syrian Arab Republic, Tanzania, Timor-Leste, Togo, Tonga, Tunisia, Turkmenistan, Tuvalu, Uganda, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe

Source: Medicines Patent Pool. MedsPaL Database: Daclatasvir. Last accessed July 24, 2019. Available at:  https://medicinespatentpool.org/licence-post/daclatasvir-dcv/.

Countries eligible for generic glecaprevir/pibrentasvir (G/P)under AbbVie-MPP agreement:

Afghanistan, Angola, Antigua and Barbuda, Bangladesh, Belize, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Cook Island, Côte d’Ivoire, Democratic Republic of the Congo, Djibouti, Dominica, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Gambia, Georgia, Ghana, Grenada, Guinea, Guinea-Bissau, Guyana, Haiti, Indonesia, Jordan, Kenya, Kiribati, Laos, Lesotho, Liberia, Libya, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Niger, Nigeria, Niue, Pakistan, Palau, Papua New Guinea, Philippines, Rep., Rwanda, Saint Kitts and Nevis, Saint Lucia, Saint Vincent & the Grenadines, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Suriname, Swaziland, Tanzania, Timor-Leste, Togo, Tunisia, Turkmenistan, Tuvalu, Uganda, Vanuatu, Vietnam, West Bank & Gaza, Yemen, Zambia, Zimbabwe

Source: Medicines Patent Pool. MedsPaL Database: glecaprevir/pibrentasvir. Last accessed July 24, 2019. Available at: https://medicinespatentpool.org/licence-post/glecaprevirpibrentasvir-gp/.