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Antiretroviral medicines in low- and middle-income countries: forecasts of global and regional demand for 2014-2018

10 июля 2015 г. Всемирная организация здравоохранения

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TECHNICAL REPORT

AIDS MEDICINES AND DIAGNOSTICS SERVICE

ANTIRETROVIRAL MEDICINES IN LOW-AND MIDDLE-INCOME COUNTRIES: FORECASTS OF GLOBAL AND REGIONAL DEMAND FOR 2014-2018 JULY 2015

WHO Library Cataloguing-in-Publication Data: Antiretroviral medicines in low- and middle-income countries: forecasts of global and regional demand for 2014-2018. 1.Anti-Retroviral Agents – supply and distribution. 2.HIV Infections – therapy. 3.Drug Industry - trends. 4.Developing Countries. I.World Health Organization. ISBN 978 92 4 150915 2 (NLM classification: WC 503.2) © World Health Organization 2015 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Layout: Blossoming.it

CONTENTS LIST OF FIGURES LIST OF TABLES ACKNOWLEDGEMENTS ABBREVIATIONS AND ACRONYMS EXECUTIVE SUMMARY 1. INTRODUCTION 2. METHODS FOR DETERMINING KEY FORECAST VARIABLES 2.1.1 Linear projection 2.1.2 Country target projection 2.1.3 CHAI projection 2.1.4 Fast Track projection 6 7 8 9 10 12 14 16 16 16 17

2.1 TOTAL NUMBER OF PEOPLE RECEIVING TREATMENT14

2.2 NUMBER OF PEOPLE RECEIVING FIRST- AND SECOND-LINE THERAPY17 2.3 PROPORTION OF ADULTS AND CHILDREN RECEIVING TREATMENT BY ARV DRUG18 2.3.1 Observed trend in regimens based on a survey of ARV drug use 2.3.2 Observed procurement trend from the GPRM database 2.3.3 Regimen distribution forecast by SCMS 2.3.4 Regimen distribution forecast by CHAI 2.3.5 Regimen distribution forecast by the Global Fund 2.4 CALCULATING THE NUMBER OF WOMEN RECEIVING ARV DRUGS FOR PMTCT 3. FORECASTING THE DEMAND FOR ACTIVE PHARMACEUTICAL INGREDIENTS 19 19 19 19 19 28 30

3.1 CALCULATING THE API PERSON-YEARS30 3.2 CALCULATING THE TOTAL VOLUMES OF APIS REQUIRED FOR EACH ARV DRUG31 3.3 FORECAST DEMAND FOR APIS FOR 2014–201831 3.4 ARV FORMULATIONS33 4. DISCUSSION 36

REFERENCES 37 ANNEX 1 38

LIST OF FIGURES Fig. 1. Model used for forecasting ARV drug demand Fig. 2. Comparison of projections of the number of people receiving ART, 2001–2018 Fig. 3. Number of adults and children receiving first- and second-line ART, 2013–2018, based on the average of three projections Fig. 4. Projected adult market share (%) of d4T as a proportion of the adult volume of primary NRTIs, 2011–2018 Fig. 5. Projected paediatric market share (%) of d4T as a proportion of the paediatric volume of primary NRTIs, 2011–2018 Fig. 6. Projected adult market share (%) of TDF as a proportion of the adult volume of primary NRTIs, 2011–2018 Fig. 7. Projected paediatric market share (%) of TDF as a proportion of the paediatric volume of primary NRTIs, 2011–2018 Fig. 8. Projected adult market share (%) of AZT as a proportion of the adult volume of primary NRTIs, 2011–2018 Fig. 9. Projected paediatric market share (%) of AZT as a proportion of the paediatric volume of primary NRTIs, 2011–2018 Fig. 10. Projected market share (%) of ABC as a proportion of the adult volume of primary NRTIs, 2011–2018 Fig. 11. Projected paediatric market share (%) of ABC as a proportion of the paediatric volume of primary NRTIs, 2011–2018 Fig. 12. Projected market share (%) of ddI as a proportion of the adult volume of primary NRTIs, 2011–2018 Fig. 13. Projected adult market share (%) of 3TC and FTC as a proportion of the adult volume of secondary NRTIs, 2011–2018 Fig. 14. Projected paediatric market share (%) of 3TC as a proportion of the paediatric volume of secondary NRTIs, 2011–2018 Fig. 15. Projected adult market share (%) of NVP and EFV as proportions of the adult volume of NNRTIs, 2011–2018 Fig. 16. Projected paediatric market share (%) of NVP, EFV and LPV as proportions of the paediatric volume of NNRTIs and PIs, 2011–2018 Fig. 17. Projected adult market share (%) of LPV and ATV as proportions of the adult PI volume, 2011–2018 Fig. A1. Number of people receiving first- and second-line ART based on linear projection, 2013–2018 Fig. A2. Number of people receiving first- and second-line ART based on country target projection, 2013–2018 Fig. A3. Number of people receiving first- and second-line ART based on CHAI data, 2013–2018 Fig. A4. Number of people receiving first- and second-line ART in sub-Saharan Africa based on the average of linear and country target projections, 2013–2018 Fig. A5. Number of people receiving first- and second-line ART in Latin America and the Caribbean based on the average of linear and country target projections, 2013–2018 Fig. A6. Number of people receiving first- and second-line ART in the Eastern Mediterranean based on the average of linear and country target projections, 2013–2018 Fig. A7. Number of people receiving first- and second-line ART in Europe based on the average of linear and country target projections, 2013–2018 Fig. A8. Number of people receiving first- and second-line ART in South and South-East Asia based on the average of linear and country target projections, 2013–2018 Fig. A9. Number of people receiving first- and second-line ART in the Western Pacific based on the average of linear and country target projections, 2013–2018 13 16 18 20 20 21 21 22 22 23 23 24 24 25 25 26 26 51 52 52 53 54 54 55 55 56

LIST OF TABLES Table 1. Summary of assumptions made in the forecast scenarios Table 2. Summary of assumptions made in the forecast scenarios Table 3. Number of adults and children receiving treatment by scenario and average, 2014–2018 Table 4. Proportion of people receiving second-line ART, 2013–2018 Table 5. Average market share for adult ARV drugs Table 6. Average market share for paediatric ARV drugs Table 7. Total and average number of women receiving ARV drugs for PMTCT, 2014–2018 Table 8. Projected regimen mix for women receiving ARV drugs for PMTCT, 2012 and 2018 Table 9. API demand volume in person-years, based on the average of three projections Table 10. Adult and paediatric daily doses for ARV drugs, based on WHO recommendations Table 11. Volume of demand for APIs in metric tonnes based on the average of linear, CHAI and country target projections, 2013–2018 Table 12. Volume of demand for APIs in metric tonnes for women on PMTCT based on the average of linear and country target projections, 2013–2018 Table 13. Comparison of ARV formulation forecast between CHAI projected procurement and aggregation of SCMS and Global Fund procurement data in person-years, 2014–2016 11 14 15 17 27 28 28 29 30 31 32 32 33

Table A1. Projected number of people receiving ART by region based on the average of linear and country target projections, 2014–2018 38 Table A2. Number of women receiving ARV drugs for PMTCT by region, based on the average of linear and country target projections, 2014–2018 Table A3. Volume of demand for APIs in person-years: linear projection, 2014–2018 Table A4. Volume of demand for APIs in person-years: country target projection, 2014–2018 Table A5. Volume of demand for APIs in person-years: CHAI projection, 2014–2018 Table A6. Volume of demand for APIs in metric tonnes: linear projection, 2014–2018 Table A7. Volume of demand for APIs in metric tonnes: country target projection, 2014–2018 Table A8. Volume of demand for APIs in metric tonnes based on CHAI projection, 2014–2018 Table A9. Volume of demand for APIs in metric tonnes in sub-Saharan Africa based on the average of linear and country target projections, 2014–2018 Table A10. Volume of demand for APIs in metric tonnes in Latin America and the Caribbean based on the average of linear and country target projections, 2014–2018 Table A11. Volume of demand for APIs in metric tonnes in the Eastern Mediterranean based on the average of linear and country target projections, 2014–2018 Table A12. Volume of demand for APIs in metric tonnes in Europe based on the average of linear and country target projections, 2014–2018 Table A13. Volume of demand for APIs in metric tonnes in South and South-East Asia based on the average of linear and country target projections, 2014–2018 Table A14. Volume of demand for APIs in metric tonnes in the Western Pacific based on the average of linear and country target projections, 2014–2018 Table A15. CHAI ARV formulation projections in person-years, 2014–2016 Table A16. Global Fund ARV formulation projections in person-years, 2015–2016 Table A17. SCMS ARV formulation projections in person-years, 2015–2016 39 39 40 40 41 41 42 42 43 43 44 44 45 45 47 49

ACKNOWLEDGEMENTS Technical Working Group member organizations • Avenir Health represented by John Stover and Adebiyi Adesina; • Clinton Health Access Initiative represented by Jessica Fast, Vineet Prabhu, Vadim Shepel, Marianne Gauval, Cebele Wong, Sarah Jenkins and Michelle Vogelzang; • Medicines Patent Pool represented by Aastha Gupta, Fernando Pascual and Sandeep Juneja; • Partnership for Supply Chain Management represented by Rich Owens, David Jamieson, Gordon Comstock, Robert Burn, Robert Bush, Dominique Zwinkels, Chris Larson, Wesley Kreft, Claire Albert and Oluwaseun Ayanniyi; • South African National Department of Health represented by Gavin Steel; • The Global Fund to fight AIDS, Tuberculosis and Malaria represented by Martin Auton; • The Joint United Nations Programme on HIV/AIDS (UNAIDS) secretariat represented by Carlos Passarelli; • The United Nations Children’s Fund represented by Gitanjali Sakhuja; • United States Agency for International Development – Office of the United States Global AIDS Coordinator represented by Christine Malati, Jacqueline Firth and Joshua Rosenfeld; • The World Health Organization (WHO) represented by Jos Perriëns and Vincent Habiyambere.

WHO and UNAIDS staff • The World Health Organization represented by Meg Doherty, Boniface Dongmo Nguimfack, Marco Vitoria and Martina Penazzato for their technical contributions to finalize the forecasts. • The Joint United Nations Programme on HIV/AIDS (UNAIDS) secretariat represented by Peter Ghys and Mary Mahy for their technical contributions.

Financial acknowledgement Funding to support this work came from the UNAIDS secretariat and the United States Agency for International Development who provided financial and technical support. The development of this work was coordinated by Jos Perriëns and Vincent Habiyambere to whom any comments should be sent by email at hiv-aids@who.int.

ABBREVIATIONS AND ACRONYMS 3TC ABC API ART ARV ATV ATV/r AZT CHAI d4T EFV FTC FL GF Global Fund GPRM LPV LPV/r NNRTI NRTI NtRTI NVP PFSCM PI SCMS SL TDF TEE TLE UNAIDS UNICEF lamivudine abacavir active pharmaceutical ingredient antiretroviral therapy antiretroviral atazanavir ritonavir-boosted atazanavir zidovudine (also known as ZDV) Clinton Health Access Initiative stavudine efavirenz emtricitabine first-line Global Fund Global Fund to Fight AIDS, Tuberculosis and Malaria Global Price Reporting Mechanism lopinavir ritonavir-boosted lopinavir non-nucleoside reverse-transcriptase inhibitor nucleoside reverse-transcriptase inhibitor nucleotide reverse-transcriptase inhibitor nevirapine Partnership for Supply Chain Management protease inhibitor Supply Chain Management System second-line tenofovir tenofovir-emtricitabine-efavirenz tenofovir-lamivudine-efavirenz Joint United Nations Programme on HIV/AIDS United Nations Children’s Fund

EXECUTIVE SUMMARY The number of people on treatment in low- and middle-income countries continues to show promising growth indicating that the global effort to scale up HIV treatment to reach 15 million people by the end of 2015 will be achieved. At the end of 2013, the number of people receiving antiretroviral therapy (ART) had reached 11.7 million, an increase of 1.8 million from the previous year (1, 2). The goal of this report is to provide countries and suppliers with estimates of the global market for antiretroviral (ARV) medicines in low- and middle-income countries up to 2018. The report includes estimates of the global demand for both active pharmaceutical ingredients (APIs) and ARV formulations to enable suppliers to manage their manufacturing capacity accordingly. In this report, three forecasting approaches are used to project the demand for ART expressed as the number of people on treatment from 2014–2018: • the linear regression forecast extrapolates from the historical trends of the previous three years (2011, 2012 and 2013) in the number of people receiving ARV drugs; • the country target model reflects the reported programme goals of national programmes; • the approach of the Clinton Health Access Initiative (CHAI) focuses on the experience of countries with a high burden of HIV infection; and In addition, the above 3 projections and their average are compared to the Fast Track projection, which assumes that by 2020, 90% of all people living with HIV will know their status, 90% of people who know their status will receive treatment and 90% of people on treatment will achieve viral suppression. The linear and the country target approaches use data from the 2013 WHO survey on ARV drug use, augmented in the CHAI model by data from the progress report towards universal access and country information ( 2, 4, 5, 6, 7 ). The assumptions underlying the forecasts for demand for APIs for 2014–2018 were developed through the work of the Technical Working Group Meeting on Global Antiretroviral Demand Forecast, which included staff from CHAI, Avenir Health (formerly Futures Institute), the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund),the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Office of the United States Global AIDS Coordinator, the Partnership for Supply Chain Management, the United Nations Children’s Fund (UNICEF), the United States Agency for International Development (USAID) and the World Health Organization (WHO). The Technical Working Group coordinated several sources of data on ARV drugs, including the WHO survey on ARV drug use, the Global Price Reporting Mechanism (GPRM) data on procurement, Supply Chain Management System (SCMS) procurement, national guidelines and CHAI data on drug recipients to consolidate key assumptions and generate the projected demand for APIs. This year’s report was able to build on the depth of historical data to improve the accuracy of forecasting demand. As a result, the distribution of adults and children receiving ARV treatment was calculated based on the average of five sources of data: the 2014 WHO survey of ARV drug use, GPRM procurement data, the Global Fund projected procurement for 2015 and 2016, SCMS procurement data and CHAI’s global ARV forecast. For adult patients, individual ARV drugs were categorized under four market categories: • Primary nucleoside reverse-transcriptase inhibitors (NRTIs) and nucleotide reverse-transcriptase inhibitors (NtRTIs): stavudine (d4T), zidovudine (AZT), tenofovir (TDF), abacavir (ABC) and didanosine (ddI). • Secondary NRTIs: lamivudine (3TC) and emtricitabine (FTC). • Non-nucleoside reverse-transcriptase inhibitors (NNRTIs): nevirapine (NVP) and efavirenz (EFV). • Protease inhibitors (PIs): ritonavir-boosted lopinavir (LPV/r) and ritonavir-boosted atazanavir (ATV/r).

For paediatric patients, individual PIs were categorized under three market categories: • NRTIs and NtRTIs: d4T, AZT, TDF and abacavir (ABC). • Secondary NRTIs: 3TC and FTC. • NNRTIs and PIs: NVP, LPV/r and ATV/r. The projections for the adult and paediatric API market are shown in Fig. 4–17. In addition to providing estimated demand for APIs, this report includes estimated demand for ARV formulations (in personyears) based on projected procurement data from CHAI, the Global Fund and SCMS for 2014 to 2016 (Tableaux 13, 15-17). The figures in this report are not meant to be definitive consumption of ARVs from 2014 to 2018; rather, they provide a range of possible demand if current trends continue. The linear regression approach projects 19.7 million people receiving treatment by 2018, the CHAI forecast estimates 19.7 million, the country target approach projects 30.7 million, while the Fast Track projection estimates 23.8 million. The average projection of the three approaches reaches 23.5 million by 2018. Table 1 shows the results for the number of people receiving ART, the proportion of people on first- and second-line therapy, and the number of HIV-infected women receiving ARVs for prevention of mother-to-child-transmission (PMTCT).

Table 1. Number of adults and children receiving treatment (average scenario), and number of women receiving ARV drugs for PMTCT, based on average of linear and country target projections (millions), 2014–2018 Number of people receiving ART or ARV drugs for PMTCT Number of adults receiving ART (millions) 2014 13.1 [12.0–15.1]a Number of children receiving ART (millions) 0.89 [0.74–1.2] Number of people receiving ART (millions) 14.0 [12.8–16.3] Proportion of people receiving first-line ART (%) Proportion of people receiving second-line ART (%) Number of women receiving ARV drugs for PMTCT, based on average of linear and country target projections (millions) 94.8 2015 15.6 [14.2–18.6] 1.0 [0.79–1.3] 16.6 [15.0–19.9] 94.6 2016 17.5 [16.0–22.0] 1.1 [0.84–1.5] 18.6 [16.7–23.5] 94.5 2017 19.9 [17.3–25.2] 1.2 [0.90–1.9] 21.1 [18.2–27.1] 94.3 2018 22.1 [18.5–28.5] 1.4 [0.93–2.2] 23.5 [19.7–30.7] 94.1

5.2

5.4

5.5

5.7

5.9

1.6 [1.5–1.7]

1.8 [1.6–1.9]

2.0 [1.8–2.2]

2.2 [2.0–2.4]

2.4 [2.2–2.7]

Numbers in brackets show the low and high estimates.

1. INTRODUCTION The objectives of this report are to: • provide information on the projected number of people who will be on antiretroviral therapy (ART) from 2014 to 2018; • update the forecasts of global demand for antiretroviral (ARV) drugs prepared in 2013; and • forecast the global and regional demand for individual ARV drugs from 2014 to 2018. The data sources for this report are the: • reported use of ARV drugs and country planning targets for the number of people on ART from the 2012 to 2014 annual WHO surveys on the use of ARV drugs. • Global Price Reporting Mechanism (GPRM) of WHO; • quantification of ARV drugs for selected countries to be procured for 2015 and 2016, by the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund); • quantities of ARV drugs for 15 countries to be procured for 2014, 2015 and 2016, by the United States President’s Emergency Plan for AIDS Relief (PEPFAR)funded Supply Chain Management System (SCMS) project; • volumes of ARVs reported in the projection of ARV drug demand by the Clinton Health Access Initiative (CHAI); and • estimated number of people who need ART, from the Joint United Nations Programme on HIV/AIDS (UNAIDS); All these data were compiled and used to project the demand for ARV drugs from 2014 to 2018. The number of people receiving ART for the projected years is forecast using three approaches: • linear projections of historical numbers of people receiving ART by country; • country target projection, based on planning targets submitted by national programmes; and • projections by CHAI. These three approaches are explained in detail in the following pages. In general, forecasting the global demand for ARVs involves the following steps: • Project the total number of people receiving ART. • Determine the number of people receiving first-line and second-line therapy, using the average of proportions from three sources of data: • linear regression based on the World Health Organization (WHO) ARV use surveys conducted in 2012, 2013 and 2014, which assessed the use of ARV medicines at the end of 2011, 2012 and 2013 (2–6); • linear extrapolation of the relative market share of protease inhibitors (PIs) for 2010–2014 from GPRM procurement data; and • the CHAI projections for second-line therapy for 2013– 2018. • Determine the distribution of regimens for adults and children receiving first- and second-line therapy, using the average proportions from five sources of data – WHO ARV drug use survey, CHAI, SCMS, Global Fund and GPRM: • linear regression based on the WHO surveys of reported ARV use at the end of 2011, 2012 and 2013; • linear extrapolation of the relative market share of active pharmaceutical ingredients (APIs) for 2010– 2013 and part of 2014 from GPRM procurement data; • CHAI ARV market share projections for 2013–2018; • Global Fund procurement forecast for 2015 and 2016; and • SCMS country forecasts of the number of persons on ART and the regimen breakdown for 2015 and 2016. • Calculate the number of person-years of treatment for each ARV drug. • Calculate the total API volumes required to meet the forecast demand for adults and children for each ARV drug. • Calculate the number of adults and children on the most prescribed treatment regimens. The model used for forecasting ARV drug demand in this report is illustrated in Fig. 1. The calculated averages of the results of each step in terms of the numbers of people receiving ARV drugs, and the breakdown of first-line and second-line therapy and regimen use, were used as the basis to determine the final estimates of the demand for APIs for 2014–2018

Fig. 1. Model used for forecasting ARV drug demand

Projected adults and children receiving ART

Adults receiving first- and second-line ART Children receiving first- and second-line ART

Proportion of adults and children by first- and second-line ART

Volume of demand for ARVs and APIs

2. METHODS FOR DETERMINING KEY FORECAST VARIABLES 2.1. Total number of people receiving treatment The WHO global ARV drug use survey and the Global AIDS Response Progress Report (GARPR) use the same indicator for people on ART. Information in GARPR is exported into the WHO global ARV drug use survey; 146 countries provided this information. Table 2 summarizes the underlying assumptions and data sources of the three approaches to forecasting the number of people receiving ART to 2018.

Table 2. Summary of assumptions made in the forecast scenarios Forecasting method Linear projection Data sources WHO AIDS Medicines and Diagnostics Service surveys conducted from 2012 to 2014 146 (WHO ARV drug use survey conducted in 2014) 99% Country target projection Country targets for 2014–2018 CHAI projection Global progress reports published annually by WHO/ UNICEF/UNAIDS 21 highest-burden countries2

Number of countries for which data are used Proportion of people in low- and middle-income countries receiving treatment represented in the data set Underlying assumption

471

53% (extrapolated to the remaining 47% of low- and middle-income countries)3 National programme planning targets will be achieved

85% (extrapolated to the remaining 15% of patients in low- and middle-income countries) Number of people receiving treatment will increase linearly at the same rate as the linear trend observed in 2011–2013 and will plateau as universal access is achieved

Number of people receiving ARV drugs will increase linearly at the same rate as the linear trend observed in 2011–2013, with the rate of increase limited by the number of people estimated to need treatment by 2018 using 2013 WHO consolidated eligibility criteria

Belarus, Benin, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Côte d’Ivoire, Cuba, Democratic Republic of the Congo, Ecuador, Egypt, El Salvador, Ethiopia, Gabon, Guinea, Guyana, Iran (Islamic Republic of), Iraq, Kenya, Lao People’s Democratic Republic, Liberia, Malawi, Malaysia, Mali, Morocco, Myanmar, Nicaragua, Nigeria, Oman, Paraguay, Peru, Philippines, Republic of Moldova, Senegal, Seychelles, Syrian Arab Republic, Thailand, Togo, Tunisia, Uganda, United Republic of Tanzania, Viet Nam, Zambia and Zimbabwe. 2 Botswana, Brazil, Cameroon, China, Côte d’Ivoire, Ethiopia, India, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Swaziland, Thailand, Uganda, United Republic of Tanzania, Zambia and Zimbabwe. 3 For details of the composition of the geographical regions, see the explanatory notes for classification of low- and middle-income countries by income level, epidemic level and geographical, UNAIDS, UNICEF and WHO regions on page 152 in Global HIV/AIDS response: epidemic update and health sector progress towards universal access: progress report 2011 (6). 1

The results for each of the three methods were summed and divided by three to give the average estimated number of people on ART for all low- and middle-income countries. Table 3 and Fig. 2 present the three projection scenarios of the estimated number of people receiving ART from 2014 to 2018 and the average of the three projections. Table A1 provides the average number of people receiving treatment by region for the linear and country target projections.

The linear projection and CHAI projection are similar, except for the addition of women starting on ART through option B+ for prevention of mother-to-child-transmission (PMTCT) in the linear projection. The country target projection varies from these two scenarios because the estimates are informed by the aspirations of each reporting country to reach the goal of universal access to treatment by 2015.

Table 3. Number of adults and children receiving treatment by scenario and average, 2014–2018 Forecasting method Linear projection Age group Adults Children Total Country target projection CHAI projection Adults Children Total Adults Children Total Fast Track Adults Children Total Average Adults Children Total 2014 12 500 000 740 000 13 200 000 15 100 000 1 200 000 16 300 000 12 700 000 820 000 13 500 000 12 000 000 800 000 12 800 000 13 100 000 900 000 14 000 000 2015 14 200 000 790 000 15 000 000 18 600 000 1 300 000 19 900 000 14 500 000 910 000 15 400 000 14 900 000 900 000 15 800 000 15 600 000 1 000 000 16 600 000 2016 15 900 000 840 000 16 700 000 22 000 000 1 500 000 23 500 000 16 200 000 1 000 000 17 200 000 16 000 000 1 000 000 17 000 000 17 500 000 1 100 000 18 600 000 2017 17 300 000 890 000 18 200 000 25 200 000 1 900 000 27 100 000 17 600 000 1 100 000 18 700 000 19 400 000 1 100 000 20 500 000 19 900 000 1 200 000 21 100 000 2018 18 800 000 930 000 19 700 000 28 500 000 2 200 000 30 700 000 18 500 000 1 200 000 19 700 000 22 600 000 1 200 000 23 800 000 22 100 000 1 400 000 23 500 000

Fig. 2. Comparison of projections of the number of people receiving ART, 2001–2018

35 30 25 Millions 20 15 10 5 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Observed trend Linear Fast Track Country Targets CHAI Average 30.7 23.8 23.5 19.7

2.1.1 Linear projection This forecast estimates the annual increase in the number of people receiving treatment based on responses from the 146 countries mentioned under Section 2.1, representing approximately 99% of the number of people receiving treatment in all 154 low- and middle-income countries. The survey data are then used to plot a linear regression line fitted to the number of adults and children receiving ART over the past three years (2011, 2012 and 2013), as reported in the WHO/UNAIDS/UNICEF reports on universal access to HIV prevention, treatment, care and support ( 4–6 ). The regression fit uses the actual month and year of each report and the results of applying linear regression were constrained by the UNAIDS estimated total need for ART (from Spectrum projections for each country prepared in cooperation with UNAIDS). The total need for ARV drugs is defined as everyone currently receiving ART, plus those who meet the eligibility criteria but are not receiving ART. With the 2013 update to the WHO treatment guidelines on the use of ARV drugs recommending a higher CD4 threshold for initiating treatment, and the scale up of treatment for prevention and option B+ for PMTCT, the total number of people who need treatment has increased from previous estimates (7 ) of 15.7 million by 2016 to 16.7 million. The linear approach is constrained by the estimated number of people who need ART projected for 2018 based on WHO 2013 treatment recommendations. Since option B+ for PMTCT is already being scaled up or being considered for scale up, we have added the number 1

of women initiating ART through option B+ to the linear and country target projections of the number of adults receiving ART. The number and proportion of pregnant women receiving various options for PMTCT, including lifelong ART (option B+), is shown in Table 7 in Section 2.4. This may overestimate the number of people on ART if some women on ART discontinue treatment when they stop breastfeeding.

2.1.2 Country target projection Most countries set their own targets for the number of people they expect to be receiving ART during the next three to five years. These targets consider the realities in each country and their goals for increasing coverage. For the 2014–2018 country target projections, 47 country projections in successive global WHO ARV drug use surveys were used, accounting for about half the people receiving ART in low- and middle-income countries. For countries that did not define targets, it is assumed that the total number of people receiving ART will grow at the same rate as the aggregate projection for these 47 countries. This equates to an average annual growth of nearly 4 million people per year. We assume that the number of people receiving ART and the country target projections account for the pregnant women who initiate ART for life through option B+.

2.1.3 CHAI projection Each year, CHAI derives a five-year forecast of global demand for ARVs in low- and middle-income countries. The forecast is broken down into demand by regimen,

PMTCT Option B+ is an ARV treatment in which pregnant women living with HIV initiate ART regardless of CD4 count.

country, first line versus second line, adults versus children, and generic accessible versus inaccessible countries. The data inputs use the total patient numbers in the Towards universal access progress report, published annually by WHO/UNAIDS, as the baseline. The forecast assumes that the number of people on ART will increase at the same rate as the linear trend observed over the previous three years, but plateauing as countries approach universal coverage under the 2013 WHO guidelines. The ratio of patients by regimen is evaluated based on data collected from CHAI country teams, national guidelines and historic uptake rates. To arrive at a global forecast, CHAI applies this methodology to the 21 highest-burden countries, and then extrapolates to the rest of the world. The 21 countries are: Botswana, Brazil, Cameroon, China, Côte d’Ivoire, Ethiopia, India, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Swaziland, Thailand, Uganda, United Republic of Tanzania, Zambia and Zimbabwe.

count at treatment initiation and includes the effect of ART on viral suppression and reductions in infectivity.

2.2. Number of people receiving first- and second-line therapy Three data sources were used to determine the proportion of people receiving second-line therapy: • Linear regression of the proportion of people receiving second-line therapy reported in the 2010, 2011, 2012 and 2013 WHO surveys. • Linear regression of the proportion of the people receiving PIs reported by the GPRM for 2011, 2012 and 2013 (8) and extrapolated using a linear regression to 2014 to 2018. • CHAI collects data on second-line patient numbers in the 21 highest-burden countries from country teams and published literature. CHAI then estimates future secondline patient numbers in each country by considering factors such as treatment failure rates and attrition rates. CHAI then aggregates second-line estimates across the 21 countries and extrapolates these results to patients in the remaining low- and middle-income countries. The proportion of people receiving second-line therapy is calculated by dividing this figure by the total number of patients on treatment. Table 4 shows the projected proportion of people receiving second-line therapy for each of the three data sources, which are within 1.5 percentage points of each other, as well as the average, which was used in estimating the demand for APIs.

2.1.4 Fast Track projection For comparison purposes the Fast Track projection from UNAIDS is also shown in Table 2 and Fig. 21. This projection assumes that by 2020, 90% of all people living with HIV will know their status, 90% of people who know their status will receive treatment and 90% of people on treatment will achieve viral suppression. The Fast-Track projections were made using the Spectrum/Goals model applied to 28 high burden countries, which account for over 85% of all new infections, and the results scaled up to represent all low- and middle-income countries. The model tracks new infections over time by CD4 count, age and sex. It estimates survival on ART as a function of CD4

Table 4. Proportion of people receiving second-line ART, 2013–2018 Proportion of people receiving second-line ART 2014–2018 (%) Data source WHO AIDS Medicines and Diagnostics Service survey GPRM CHAI Average 2013 5.6 2014 5.9 2015 6.0 2016 6.1 2017 6.1 2018 6.2

4.5 5.0 5.0

4.8 4.9 5.2

5.2 4.9 5.4

5.6 4.9 5.5

5.9 5.1 5.7

6.3 5.3 5.9

UNAIDS. Fast-Track: ending the AIDS epidemic by 2030. November 2014.

The average proportions of people receiving second-line therapy are then applied to the average number of adults and children receiving treatment as forecast for 2014– 2018 (see Table 3). Fig. 3 shows the number of adults and children receiving first- and second-line therapy. The number of adults and children on first- and second-line

therapy for the linear, CHAI and country target scenarios are shown in Fig. A1–A3. The average number of adults and children on first- and second-line therapy, based on the linear and country target projections for each region, are shown in Fig. A4–A9.

Fig. 3. Number of adults and children receiving first- and second-line ART, 2013–2018, based on the average of three projections 25 20 15 Millions 10 5 0 2013 Children SL Children FL Adult SL Adult FL 37 000 700 000 550 000 10 400 000 2014 46 000 840 000 680 000 12 400 000 2015 54 000 950 000 840 000 14 800 000 2016 61 000 1 040 000 970 000 16 500 000 2017 69 000 1 130 000 1 100 000 18 800 000 2018 83 000 1 320 000 1 300 000 20 800 000

2.3. Proportion of adults and children receiving treatment by ARV drug The distribution of adults and children receiving treatment by ARV drug was calculated separately using an average of five data sources: CHAI’s global ARV forecast; Global Fund projected procurement for 2014 and 2015; GPRM transaction data; SCMS procurement data; and the 2014 WHO survey of ARV drug use. With the availability of more detailed data, each forecast scenario was divided into two: regimen distributions for adult patients and for paediatric patients.

For adult patients, individual ARV drugs were categorized by the following market categories: • Primary nucleoside reverse-transcriptase inhibitors (NRTIs) and nucleotide reverse-transcriptase inhibitors (NtRTIs): stavudine (d4T), zidovudine (AZT), tenofovir (TDF), abacavir (ABC) and didanosine (ddI). • Secondary NRTIs: lamivudine (3TC) and emtricitabine (FTC). • Non-nucleoside reverse-transcriptase inhibitors (NNRTIs): nevirapine (NVP) and efavirenz (EFV).

• PIs: primarily ritonavir-boosted lopinavir (LPV/r) and ritonavir-boosted atazanavir ATV/r. For paediatric patients, individual drugs were categorized by the following market categories: • Primary NRTIs and NtRTIs: d4T, AZT, TDF and ABC. • Secondary NRTIs: ddI and 3TC. • NNRTIs and PIs: NVP, EFV and LPV/r.

2.3.3 Regimen distribution forecast by SCMS SCMS supports or collaborates with PEPFAR-country ministries of health and implementing partners to prepare annual forecasts of ARV medicines for national ART programmes. These forecasts are based on: • data current at the time of the forecast; • distribution of patients by first- and second-line regimens; and • assumptions about the evolution of this distribution over a two to three-year forecast period as national treatment guidelines address developments such as WHO recommendations and formulation options. The regimen distribution data were aggregated across the 15 PEPFAR countries1 and analysed to contribute towards the assessment of trends presented in this report.

2.3.1 Observed trend in regimens based on a survey of ARV drug use This projection method was based on observed trends in regimen use, as reported in the WHO surveys of ARV drug use from 2010 to 2013. For the countries that responded, the reported proportions of adults and children receiving each regimen were disaggregated into the percentage of adults and children receiving each individual ARV drug. For countries that did not respond to the survey, the average regional distribution was used. To forecast the ARV drug distribution from 2014 to 2018 by country, a linear regression line was fitted to the reported ARV drug distribution from 2010 to 2013 projected to 2018 but constrained to be between 0% and 100%. This methodology was applied to all PIs except indinavir, saquinavir and nelfinavir. It was assumed that since these three ARV drugs will no longer be marketed, no one will receive these by the end of 2014 and that people formerly using these three drugs will be transitioned to LPV/r and ATV/r in a ratio of 9:1, based on current GPRM data (that is, 90% are transitioned to LPV/r and 10% to ATV/r)

2.3.4 Regimen distribution forecast by CHAI Each year, CHAI derives a global ARV forecast for adults and children in low- and middle-income countries. CHAI collects data from country teams and published literature on patient regimens, national guidelines, attrition rates, failure rates, toxicity rates, future ARV trends and other key factors in the 21 highest-burden countries. CHAI then uses these data and an internally developed forecasting model to project ARV drug demand by drug and by regimen in each country over the next five years. CHAI then aggregates estimates across the 21 countries and extrapolates these results to patients in the remaining low- and middle-income countries.

2.3.2 Observed procurement trend from the GPRM database Global procurement data reported in the GPRM database were available for 2010, 2011, 2012, 2013 and partial data for 2014 (the first three quarters of 2014). The total volume procured for each category was aggregated from the annual procurement quantity for all ARV drugs in the group. The annual market share for each ARV was then calculated as its procurement volume proportional to the total annual volume for all ARVs in the same category.

2.3.5 Regimen distribution forecast by the Global Fund Global Fund regimen distribution data were based on a procurement forecast based on procurement plans for approved grants in 54 countries (2014 projection)2 and 30 countries (2015 and 2016 projection). 3 Fig. 4–17 show the trends for all five approaches plus the average for each ARV drug for adults as well as the four approaches plus the average for children.

Botswana, Burundi, Côte d’Ivoire, Ethiopia, Guyana, Haiti, Mozambique, Namibia, Nigeria, Rwanda, Tanzania, Uganda, Viet Nam, Zambia and Zimbabwe. Afghanistan, Angola, Bolivia, Burundi, Cambodia, Cameroon, Cape Verde, Chad, Comoros, Democratic Republic of the Congo, Côte d’Ivoire, Djibouti, Egypt, El Salvador, Ethiopia, Gambia, Georgia, Ghana, Guinea, Haiti, Honduras, India, Indonesia, Iran (Islamic Republic of), Kenya, Kyrgyzstan, Lao People’s Democratic Republic, Lesotho, Liberia, Madagascar, Mali, Mauritania, Mauritius, Morocco, multicountry Americas (CARICOM/PANCAP), Myanmar, Nepal, Niger, Nigeria, Palestine, Paraguay, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, Sri Lanka, Thailand, Timor-Leste, Uganda, United Republic of Tanzania, Viet Nam, Yemen and Zambia. 3 Armenia; Burundi; Cape Verde; Comoros; Democratic Republic of the Congo; Côte d’Ivoire; Georgia; Ghana; Honduras; Indonesia; Lao People’s Democratic Republic; Lesotho; Malawi; Mauritania; Mozambique; Nepal; Niger; Nigeria; Philippines; Sri Lanka; United Republic of Tanzania; Timor-Leste; Uganda; Viet Nam. 1 2

Fig. 4. Projected adult market share (%) of d4T as a proportion of the adult volume of primary NRTIs, 2011–2018

35% 30% 25% 20% 15% 10% 5% 0% 2011 Survey 2012 CHAI 2013 GPRM 2014 SCMS 2015 GF 2016 2017 Average 2018 1% 1% 1% 1% 1% 29%

Fig. 5. Projected paediatric market share (%) of d4T as a proportion of the paediatric volume of primary NRTIs, 2011–2018

45% 40% 35% 30% 25% 20% 15% 10% 5% 4% 0% 2011 Survey 2012 CHAI 2013 GPRM 2014 SCMS 2015 GF 2016 2017 Average 2018 11% 4% 3% 3%

Fig. 6. Projected adult market share (%) of TDF as a proportion of the adult volume of primary NRTIs, 2011–2018

90% 80% 70% 62% 60% 50% 40% 30% 20% 10% 0% 2011 Survey 2012 2013 GPRM 2014 SCMS 2015 GF 2016 2017 Average 2018 53% 67% 71% 72% 71%

Fig. 7. Projected paediatric market share (%) of TDF as a proportion of the paediatric volume of primary NRTIs, 2011–2018

9% 8% 7% 6% 5% 4% 3% 2% 1% 0% 2011 Survey 2012 CHAI 2013 GPRM 2014 SCMS 2015 GF 2016 2017 Average 2018 1% 1% 1% 2% 3% 4% 5%

Fig. 8. Projected adult market share (%) of AZT as a proportion of the adult volume of primary NRTIs, 2011–2018

60% 50% 40% 30% 20% 10% 0% 2011 Survey 2012 CHAI 2013 GPRM 2014 SCMS 2015 GF 2016 2017 Average 2018 40% 37% 33% 29% 27% 27%

Fig. 9. Projected paediatric market share (%) of AZT as a proportion of the paediatric volume of primary NRTIs, 2011–2018

90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 2011 Survey 2012 CHAI 2013 GPRM 2014 SCMS 2015 GF 2016 2017 Average 2018 47% 61% 66% 6... 58% 56%

Fig. 10. Projected market share (%) of ABC as a proportion of the adult volume of primary NRTIs, 2011–2018

3% 2% 2% 1% 1% 0% 2011 Survey GPRM GF 2012 Average 2013 2014 2%

Fig. 11. Projected paediatric market share (%) of ABC as a proportion of the paediatric volume of primary NRTIs, 2011–2018

50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 2011 Survey 2012 CHAI 2013 GPRM 2014 SCMS 2015 GF 2016 2017 Average 2018 27% 28% 28% 35% 38%

Fig. 12. Projected market share (%) of ddI as a proportion of the adult volume of primary NRTIs, 2011–2018

3% 2% 2% 1% 1% 0% 2011 Survey GPRM GF 2012 Average 2013 2014 1%

Fig. 13. Projected adult market share (%) of 3TC and FTC as a proportion of the adult volume of secondary NRTIs, 2011–2018

120%

100% 82% 85% 82% 60% 79% 79% 70%

80%

40% 21% 21% 30%

20%

15%

18%

0% 2011 Survey 3TC CHAI 3TC GPRM 3TC 2012 SCMS 3TC GF 3TC Average 3TC 2013 2014 Survey FTC CHAI FTC GPRM FTC 2015 SCMS FTC GF FTC Average FTC 2016 2017 2018

Fig. 14. Projected paediatric market share (%) of 3TC as a proportion of the paediatric volume of secondary NRTIs, 2011–2018

100% 90% 80% 70% 60% 50%

99%

100%

2011 Survey

2012 CHAI

2013 GPRM

2014 SCMS

2015 GF

2016

2017 Average

2018

Fig. 15. Projected adult market share (%) of NVP and EFV as proportions of the adult volume of NNRTIs, 2011–2018 100% 90% 80% 70% 60% 50% 40% 30% 34% 20% 10% 0% 2012 Survey 3TC CHAI 3TC GPRM 3TC SCMS 3TC GF 3TC Average 3TC 2013 2014 Survey FTC CHAI FTC GPRM FTC 2015 SCMS FTC GF FTC Average FTC 2016 2017 2018 27% 30% 27% 28% 48% 66% 73% 70% 73% 72%

Fig. 16. Projected paediatric market share (%) of NVP, EFV and LPV as proportions of the paediatric volume of NNRTIs and PIs, 2011–2018 80% 70% 63% 60% 50% 40% 30% 20% 10% 0% 9% 2011 Survey 3TC CHAI 3TC GPRM 3TC 11% 11% 13% 17% 17% 20% 25% 24% 26% 27% 26% 20% 60% 59% 57% 53% 54%

2012 SCMS 3TC GF 3TC Average 3TC

2013

2014 Survey FTC CHAI FTC GPRM FTC

2015 SCMS FTC GF FTC Average FTC

2016

2017 Survey LPV CHAI LPV GPRM LPV

2018 SCMS LPV GF LPV Average LPV

Fig. 17. Projected adult market share (%) of LPV and ATV as proportions of the adult PI volume, 2011–2018 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 2011 Survey 3TC CHAI 3TC GPRM 3TC 2012 SCMS 3TC GF 3TC Average 3TC 2013 2014 Survey FTC CHAI FTC GPRM FTC 2015 SCMS FTC GF FTC Average FTC 2016 2017 2018 28% 24% 36% 31% 33% 76% 72% 64% 69% 67% 90%

As Fig. 4–17 show, the market share projections for adult and paediatric patients were within a 10% range, indicating fairly similar estimates.

Tables 5 and 6 show the annual average market share of the projections for each ARV for adult and paediatric patients separately.

Table 5. Average market share for adult ARV drugs ARV drug 2014

Average market share (%) 2015 2016 2017 2018 d4T, TDF and AZT share of primary NRTIs

d4T TDF AZT

1 62 37

1 67 33

1 70 30

1 72 27

1 71 27

3TC and FTC share of secondary NRTIs 3TC FTC ABC1 ddI91 85 15 2 1 84 16 1 1 NVP and EFV share of NNRTIs NVP EFV 38 61 33 67 LPV/r and ATV/r share of PIs LPV ATV 60 27 52 36 52 39 58 31 67 33 30 70 27 73 28 72 84 16 1 1 79 21 1 1 70 30 1 1

Average market share based on WHO Survey and GPRM data.

Table 6. Average market share for paediatric ARV drugs ARV drug 2014

Average market share (%) 2015 2016 2017 2018 d4T, TDF, AZT and ABC share of primary NRTIs

d4T TDF AZT ABC

11 1 61 27

4 2 66 28

3 3 66 28

3 4 58 35

4 3 56 38

3TC and ddI share of secondary NRTIs 3TC ddI 99 1 100 1 NVP, EFV and LPV share NVP EFV LPV 63 23 13 59 24 17 57 26 17 53 27 20 54 26 20 100 1 100 1 100 1

2.4. Calculating the number of women receiving ARV drugs for PMTCT The number of women receiving ARV drugs for PMTCT was based on two projections – linear and country target. The linear projection is based on linear regression of data on PMTCT from 2011 to 2013, whereas the country targets are based on the goals set by 47 countries. Table 7 shows the projected number of women receiving ARV drugs for PMTCT for each projection, as well as the average of the two projections. Table A2 shows the estimated average number of women receiving ARV drugs for PMTCT by region, based on linear and country target projections.

Table 7. Total and average number of women receiving ARV drugs for PMTCT, 2014–2018 Forecasting method Linear projection Country target projection Average Annual rate of increase (%)

No. of women receiving ARV drugs for PMTCT 2014 1 500 000 1 700 000 1 600 000 – 2015 1 600 000 1 900 000 1 800 000 13 2016 1 800 000 2 200 000 2 000 000 11 2017 2 000 000 2 400 000 2 200 000 10 2018 2 200 000 2 700 000 2 400 000 9

As the average of the two projections shows, the number of women receiving ARV drugs for PMTCT is expected to increase, mostly because of expanded coverage of services for PMTCT. To project the demand for ARV drugs for women receiving ARV drugs for PMTCT, the total number of women receiving current WHO-recommended regimens (Table 7) – WHO 2006 AZT, option A, option B and option B+ – was determined through the WHO ARV drug use survey and the global ART access progress report, Global AIDS response progress reporting ( 9). Most country programmes are rapidly scaling down option A and B and a number of countries with a high burden of PMTCT, including Malawi

and Uganda, are now using option B+, while others, like Zambia, are considering it. As a result, we expect the distribution of regimens for PMTCT to change dramatically in the next few years. We have assumed that single-dose NVP – WHO 2006 AZT regimens, Option A – would be discontinued by 2018 and that the use of Option B and ART would rise substantially, as shown in Table 8. The number of women receiving each regimen is determined by multiplying the number of women receiving services for PMTCT by the regimen mix in that year. The volume of ARV drugs required is calculated by multiplying the number of women receiving each regimen by the recommended doses.

Table 8. Projected regimen mix for women receiving ARV drugs for PMTCT, 2012 and 2018 Regimen Single-dose NVP (%)b WHO 2006 AZT (other) (%)c Option A (%)d Option B (%)e Triple ART (%)f

Projected regimen mix for women receiving ARV drugs for PMTCT 2013a 0 0 0 53 47 2018 0 0 0 30 70

Proportion of various PMTCT options developed by WHO and UNAIDS and provided by the Strategic Information Planning Unit, HIV/AIDS Department, WHO. Single-dose NVP. One or two courses of single-dose NVP during and after labour. c WHO 2006 AZT. Starting at 28 weeks of pregnancy, this treatment recommends a regimen of twice-daily AZT, single-dose NVP at the onset of labour and AZT + 3TC during delivery and 1 week postpartum. d Option A. Starting at 14 weeks of pregnancy or soon thereafter, recommending twice-daily AZT for the mother and infant prophylaxis with either AZT or NVP for 6 weeks after birth for infants not breastfeeding. e Option B. Triple-therapy regimen, usually AZT + 3TC + NVP during pregnancy and breastfeeding. f Triple ART. Lifelong triple therapy for the mother’s health based on each country’s eligibility criteria. This includes option B+, which is lifelong treatment for mothers regardless of CD4 count. a b

3. FORECASTING THE DEMAND FOR ACTIVE PHARMACEUTICAL INGREDIENTS This section provides details of the forecast for API volumes in person-years and metric tonnes. Its objective is to assist suppliers in ensuring that adequate manufacturing capacity is available to meet the demand for ARV drugs.

3.1. Calculating the API person-years The number of person-years is estimated as the number of people who continue on that ARV drug from the previous year plus half the number of people who start on that ARV drug during the year. This assumes that the starting dates for those initiating ART that year are evenly distributed throughout the year. These calculations are summed across all countries and types of treatment (first- and second-line therapy for adults and children) to calculate the total demand in person-years. Table 9 shows the API volume in person-years for each ARV drug based on the average of the three projections – linear, country target and CHAI.

Table 9. API demand volume in person-years, based on the average of three projections Demand for APIs (person-years) based on the average of linear, CHAI and country target projected number of patients and API market share 2014 d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTVa 437 000 4 800 000 6 700 000 333 000 142 000 9 800 000 2 200 000 5 200 000 6 200 000 427 000 237 000 665 000 2015 355 000 5 400 000 9 200 000 443 000 179 000 11 800 000 2 500 000 5 400 000 8 400 000 529 000 312 000 800 000 2016 285 000 5 800 000 11 800 000 537 000 227 000 13 800 000 2 800 000 5 400 000 10 500 000 597 000 393 000 1 000 000 2017 327 000 6 200 000 14 100 000 742 000 282 000 14 900 000 3 700 000 5 600 000 12 400 000 799 000 384 000 1 200 000 2018 396 000 7 000 000 15 900 000 902 000 326 000 15 100 000 5 300 000 6 200 000 13 700 000 935 000 431 000 1 400 000

Drug

Volume of demand is based on the averages for linear and country target projections.

3.2. Calculating the total volumes of APIs required for each ARV drug The volumes required for each ARV drug are calculated as the product of the number of person-years of use, the recommended daily dose and 365 days per year. Table 10 shows the recommended daily doses for adult and paediatric patients.

Table 10. Adult and paediatric daily doses for ARV drugs, based on WHO recommendations Drug d4T AZT TDF 3TC FTC ABC NVP EFV LPV ATV RTV (with LPV/r) RTV (with ATV/r) Adult daily dose (mg/day) 60 600 300 300 200 600 400 600 800 300 200 100

Paediatric doses (mg/day) by weight band (kg) 3.0–5.9 1 10 6 10 – 20 10 – 80 – – – 6.0–9.9 1 10 6 10 – 20 10 – 80 – – – 10.0–13.9 15 10 6 10 – 20 10 200 80 – – – 14.0–19.9 20 300 6 150 – 300 200 200 80 – – – 20.0–24.9 20 300 6 150 – 300 200 200 80 – – – 25 (adult) 30 300 200 150 – 300 200 200 80 – – –

3.3. Forecast demand for APIs for 2014–2018 Table 11 shows the volume of API in metric tonnes required for each ARV drug based on the average estimates of the numbers on treatment (see Table 3), the proportion receiving first- and second-line therapy (Table 4) and the distribution of ARV drug regimens (Fig. 4–17). Tables A3–A5 show the detailed volume demand for each of the three projections individually. Tables A6–A11 show the volume of demand in metric tonnes based on the average of the linear and country target projections for each region. The API need in metric tonnes was calculated using the average projection of number of people receiving treatment converted into person-years and then multiplied by the ARV distribution and finally multiplied by the recommended dosage for each ARV drug. Table 12 shows the volume of AZT, 3TC, NVP and LPV demand for PMTCT: single-dose NVP, dual ARV drugs, option A and option B based on the average of the linear and country target projections of the number of mothers needing PMTCT (Table 8).

Table 11. Volume of demand for APIs in metric tonnes based on the average of linear, CHAI and country target projections, 2013–2018 Demand for APIs (metric tonnes) based on the average of linear, CHAI and country target projections 2014 d4T AZT TDF ABCa ddIa 3TC FTC NVP EFV LPV ATV RTVa 9 929 726 40 14 1017 160 707 1320 134 14 38 2015 7 1085 997 53 19 1227 183 731 1787 146 23 46 2016 6 1203 1276 66 24 1433 199 719 2239 157 34 54 2017 7 1296 1524 87 29 1551 266 743 2626 194 35 67 2018 8 1380 1711 103 34 1571 384 817 2908 216 42 77

Drug

Table 12. Volume of demand for APIs in metric tonnes for women on PMTCT based on the average of linear and country target projections, 2013–2018 Demand for APIs (metric tonnes) for women on PMTCT based on the average of linear and country target projections1 2014 NVP AZT 3TC LPV RTV 7 264 132 351 88 2015 7 274 137 366 91 2016 7 277 139 370 92 2017 7 273 137 364 91 2018 7 261 131 348 87

Drug

Volume of demand is based on the averages for linear and country target projections. Note: The forecast volume demand for PMTCT does not include women on triple ART for their health or Option B+. This has been included in ARV for adult HIV treatment. a 1

3.4. ARV formulations Projections of ARV formulation requirements were compiled from three major sources – CHAI, the Global Fund and SCMS. Formulation requirement data from CHAI and SCMS were projected for 2014, 2015 and 2016 while data from the Global Fund were projected for 2015 and 2016. Data from CHAI were based on the projected number of people on each ARV formulation from 21 countries extrapolated to the rest of the world. Quantification data from SCMS and the Global Fund were converted from quantities of each ARV formulation to patient-years by multiplying the number of bottles/ packages by the smallest units in each bottle/package and dividing total quantity of smallest units of each ARV formulation by the daily dose times the number of days in one year (365 days) to obtain the number of patient-years of each formulation in both datasets, the number of patient-years from both datasets were added but not extrapolated to estimate the LMIC demand of ARV formulations. The ARV formulation data from SCMS and Global Fund are aggregated and then compared to CHAI projected formulations. It is important to note that the CHAI dataset includes South Africa while Global Fund and SCMS do not have data from South Africa. This explains the significant differences in the uptake of FTC and of the ARV paediatric formulations. Table 13 shows the CHAI projected ARV formulation data with the aggregated SCMS and Global Fund ARV formulation quantification data, side by side. ARV formulation data from each source (CHAI, the Global Fund and SCMS) are shown in Tables A15, A16 and A17 in Annex 1.

Table 13. Comparison of ARV formulation forecast between CHAI projected procurement and aggregation of SCMS and Global Fund procurement data in person-years, 2014–2016 SCMS and Global Fund ARV formulation data (person-years) 2014 3TC 10 mg/ml 3TC 150 3TC 300 ABC 20 mg/ml ABC 300 ABC 300 3TC 150 AZT 300 ABC 300 3TC 300 ABC 60 ABC 60 3TC 30 ABC 60 3TC 30 dispersible ABC 600 3TC300 ATV 150 ATV 200 1221 40 714 – 769 30 191 805 – 2294 32 616 11 925 49 869 12 157 2015 3521 54 081 – 930 42 218 4683 – 5199 36 519 68 308 70 037 1672 5253 2016 3510 83 927 – 921 60 098 4792 – 5563 52 428 93 776 84 809 1675 5292

CHAI ARV formulation data (person-years) 2014 76 644 694 472 696 191 82 061 48 254 – – 16 000 – 37 000 17 302 – – 2015 74 082 706 521 746 490 99 955 43 852 – – 3000 – 32 000 15 641 – – 2016 74 780 732 020 766 654 111 113 43 406 – – 4000 – 30 000 13 622 – –

Product

SCMS and Global Fund ARV formulation data (person-years) 2014 2015 4932 139 464 7147 5601 32 210 915 205 8219 2 065 197 94 266 278 556 225 1280 – 3 612 4 800 15 375 4951 2315 100 723 1341 1903 2778 13 956 601 165 775 2016 4932 183 890 7153 5597 31 334 950 389 8219 2 065 505 99 578 286 615 228 1196 – 3 611 4 246 3 671 5018 2298 103 728 1338 1899 2772 14 771 236 206 295 – 29 996 548 97 24 379 539 283 – 1 113 290 30 971 99 994 331 1935 1 5 608 5 441 25 637 1741 6173 14 88 11 256 348 863 24 50 434

CHAI ARV formulation data (person-years) 2014 – 71 000 – – 266 000 967 000 – 1 979 000 6000 41 000 – – – – 152 000 54 000 181 000 30 000 11 000 12 000 27 000 12 000 3000 3000 – – 429 000 2015 – 131 000 – – 277 000 1 072 000 – 1 919 000 2000 49 000 – – – – 119 000 51 000 134 000 12 000 – 1000 8000 2000 3000 3000 – – 436 000 2016 – 197 000 – – 294 000 1 176 000 – 1 859 000 5000 36 000 – – – – 94 000 46 000 137 000 5000 8000 1000 – 1000 2000 3000 – – 447 000

ATV 300 ATV/r 300/100 AZT 10 mg/ml AZT 100 AZT 300 AZT 300 3TC 150 AZT 300 3TC 150 EFV 600 AZT 300 3TC 150 NVP 200 AZT 60 3TC 30 AZT 60 3TC 30 NVP 50 d4T 12 3TC 60 d4T 12 3TC 60 NVP 100 d4T 15 d4T 20 d4T 30 d4t 30 3TC 150 (60 tab) d4t 30 3TC 150 NVP 200 d4T 6 3TC 30 d4T 6 3TC 30 NVP 50 ddI 125 ddI 200 ddI 25 ddI EC 250 ddl EC 400 DRV 300 DRV 600 EFV 200

Product

SCMS and Global Fund ARV formulation data (person-years) 2014 2015 796 823 1403 – 13 43 514 343 781 36 367 28 342 6573 533 298 20 016 668 6407 184 190 6021 3 983 – 28 858 562 279 2566 5 412 014 – 498 791 439 488 12 329 2016 819 935 1331 16 15 46 934 314 764 34 290 28 387 6380 543 943 22 726 881 7217 184 370 4498 23 384 – 35 448 592 534 1752 6 248 452 – 528 771 950 135 12 329 505 292 18 11 9 10 432 138 845 37 015 4 004 3978 629 754 5734 437 1779 184 85 3515 3 847 – 10 841 741 249 1568 1 501 213 – 740 466 74 310 –

CHAI ARV formulation data (person-years) 2014 1 541 000 – – – 70 000 288 000 14 000 – – 2 066 000 72 000 – – – – – – – 935 000 1 711 000 – 1 754 000 – 221 000 2 141 000 – 2015 1 774 000 – – – 58 000 302 000 17 000 – – 2 246 000 6000 – – – – – – – 1 023 000 2 047 000 – 2 705 000 – 199 000 2 383 000 – 2016 1 899 000 – – – 49 000 315 000 10 000 – – 2 346 000 6000 – – – – – – – 1 077 000 2 196 000 – 3 625 000 – 208 000 2 753 000 –

EFV 600 ETV 100 ETV 200 IDV 400 LPV/r 100/25 LPV/r 200/50 LPV/r(80/20mg/ml) 60ml NVP 10mg/ml 100ml NVP 10mg/ml 240ml NVP 200 NVP 50 RAL 400 RTV 100 (60 tab) SQV 200 SQV 500 TDF 150 TDF 200 TDF 250 TDF 300 TDF 300 3TC 300 TDF 300 3TC 300 + ATV/r copack TDF 300 3TC 300 EFV 600 TDF 300 3TC 300 NVP 600 TDF 300 FTC 200 TDF 300 FTC 200 EFV 600 TDF 300 3TC 300 NVP 200

While the discrepancies between the two datasets are obvious. We believe that, where trends in the uptake of different formulations go in the same direction, it provides assurance that their demand will increase in the

near future. Both datasets concur in their assessment that demand for TLE, TEE, EFV 600mg and ATV/r 300/100mg will grow quickly and that demand for d4T containing products will decrease further.

4. DISCUSSION The approach outlined in this report builds on previous annual forecasts by providing an average of projections, API market share and formulations from multiple sources that include the WHO ARV survey, ministries of health, procurement data and regional estimates. This process improves on the methodologies to estimate the number of adults and children on treatment, the proportion of people on first- and second-line therapies, and the distribution of adult and paediatric patients on different ARV medicines, as well as on demand projections for adult and paediatric formulations. More importantly, the trend in the number of people on treatment continues to grow annually despite flat-lined or reduced international funding with the likelihood that the target of 15million people on treatment by 2015 will be met or exceeded. However, it is important to note that the annual growth rate for paediatric patients continues to lag behind that of adult patients. As new initiatives, such as WHO’s 2013 consolidated treatment guidelines and PEPFAR’s Accelerating Children’s HIV/AIDS Treatment (ACT) are being adopted or scaled up, the expectation is that there will be an increase in the growth rate of paediatric ARVs.

REFERENCES 1. WHO, UNAIDS and UNICEF. Global update on HIV treatment 2013: results, impact and opportunities. Geneva, World Health Organization, 2013. (http://www.who.int/hiv/pub/progressreports/update2013/en/index.html, accessed 1 December 2013). 2. U NAIDS report on the global AIDS epidemic 2013. Geneva, UNAIDS, 2013. (http://www.unaids.org/en/media/unaids/ contentassets/documents/epidemiology/2013/gr2013/UNAIDS_Global_Report_2013_en.pdf, accessed 1 December 2013). 3. A ntiretroviral medicines in low- and middle-income countries: forecasts of global and regional demand for 2012–2015. Geneva, World Health Organization, 2013. (http://www.who.int/hiv/pub/amds/2013forecast_report/en, accessed 1 December 2013). 4. WHO, UNAIDS and UNICEF. Towards universal access: scaling up priority interventions in the health sector: progress report 2009. Geneva, World Health Organization, 2009. (http://www.who.int/hiv/pub/2009progressreport, accessed 1 December 2013). 5. WHO, UNAIDS and UNICEF. Towards universal access: scaling up priority interventions in the health sector: progress report 2010. Geneva, World Health Organization, 2010. (http://www.who.int/hiv/pub/2010progressreport, accessed 1 December 2013). 6. WHO, UNAIDS and UNICEF. Global HIV/AIDS response: epidemic update and health sector progress towards universal access: progress report 2011. Geneva, World Health Organization, 2011. (http://whqlibdoc.who.int/ publications/2011/9789241502986_eng.pdf, accessed 1 December 2013). 7. WHO, UNAIDS, UNICEF. Global report: UNAIDS report on the global AIDS epidemic 2013. Geneva: World Health Organization; 2013 (http://www.unaids.org/sites/default/files/media_asset/UNAIDS_Global_Report_2013_en_1.pdf, accessed 1 April 2015). 8. Global Price Reporting Mechanism database [online database]. Geneva, World Health Organization, 2013. (http:// www.who.int/hiv/amds/gprm/en, accessed 1 December 2013). 9. A ntiretroviral drugs for treating pregnant women and preventing HIV infection in infants: recommendations for a public health approach. 2010 version. Geneva, World Health Organization, 2010. (http://www.who.int/hiv/pub/mtct/ antiretroviral2010/en, accessed 1 May 2013). 10. C onsolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Recommendations for a public health approach. Geneva, World Health Organization, 2013. (http://www.who.int/hiv/pub/guidelines/ arv2013/download/en/index.html, accessed 1 December 2013).

ANNEX 1 Table A1. Projected number of people receiving ART by region based on the average of linear and country target projections, 2014–2018 Projected number of people receiving ART by region based on the average of linear and country target projections 2014 Sub-Saharan Africa Latin America and Caribbean Eastern Mediterranean Europe Adults Children Adults Children Adults Children Adults Children South and South-East Asia Western Pacific Adults Children Adults Children 10 800 000 820 000 1 000 000 30 000 42 000 1 800 350 000 13 000 1 100 000 63 000 800 000 37 000 2015 12 900 000 900 000 1 200 000 32 000 53 000 2 000 420 000 14 000 1 300 000 72 000 930 000 41 000 2016 15 000 000 1 000 000 1 400 000 35 000 61 000 2 400 500 000 16 000 1 500 000 81 000 1 000 000 45 000 2017 17 000 000 1 220 000 1 400 000 41 000 69 000 2 800 560 000 19 000 1 600 000 94 000 1 100 000 52 000 2018 18 900 000 1 350 000 1 500 000 44 000 77 000 3 100 640 000 21 000 1 800 000 100 000 1 300 000 57 000

Region

Age group

Table A2. Number of women receiving ARV drugs for PMTCT by region, based on the average of linear and country target projections, 2014–2018 Projected number of women receiving drugs for PMTCT based on the average of linear and country target projections 2014 Sub-Saharan Africa Latin America and Caribbean Eastern Mediterranean Europe South and South-East Asia Western Pacific 1 400 000 34 000 8 000 20 000 57 000 13 000 2015 1 600 000 40 000 10 000 22 000 69 000 15 000 2016 1 800 000 46 000 12 000 23 000 82 000 17 000 2017 2 000 000 52 000 14 000 25 000 94 000 20 000 2018 2 200 000 59 000 16 000 27 000 106 000 22 000

Region

Table A3. Volume of demand for APIs in person-years: linear projection, 2014–2018 Drug d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTV

Demand for APIs (person-years) based on the linear projection 2014 357 000 4 900 000 6 200 000 296 000 132 000 9 500 000 2 000 000 4 900 000 5 900 000 560 000 144 000 704 000 2015 269 000 5 200 000 8 400 000 359 000 155 000 10 900 000 2 200 000 4 800 000 7 800 000 619 000 224 000 800 000 2016 181 000 5 400 000 10 700 000 420 000 188 000 12 400 000 2 200 000 4 500 000 9 600 000 653 000 309 000 1 000 000 2017 230 000 5 600 000 12 600 000 537 000 219 000 13 000 000 3 200 000 4 600 000 11 000 000 828 000 278 000 1 100 000 2018 322 000 6 300 000 13 900 000 616 000 246 000 12 400 000 5 000 000 5 100 000 11 900 000 918 000 317 000 1 200 000

Table A4. Volume of demand for APIs in person-years: country target projection, 2014–2018 Drug d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTV

Demand for APIs (person-years) based on the country target projection 2014 418 000 5 600 000 7 000 000 371 000 151 000 10 700 000 2 300 000 5 600 000 6 700 000 650 000 163 000 813 000 2015 354 000 6 800 000 10 700 000 527 000 204 000 14 000 000 2 800 000 6 300 000 9 900 000 834 000 288 000 1 100 000 2016 257 000 7 600 000 14 700 000 653 000 267 000 17 000 000 3 000 000 6 300 000 13 000 000 934 000 422 000 1 400 000 2017 347 000 8 400 000 18 400 000 947 000 346 000 18 800 000 4 500 000 6 800 000 15 700 000 1 287 000 407 000 1 700 000 2018 514 000 10 000 000 21 300 000 1 188 000 406 000 18 900 000 7 500 000 8 000 000 17 800 000 1 527 000 496 000 2 000 000

Table A5. Volume of demand for APIs in person-years: CHAI projection, 2014–2018 Drug d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTV

Demand for APIs (person-years) based on CHAI patient projection 2014 537 000 4 000 000 6 900 000 9 121 000 2 371 000 5 000 000 6 000 000 100 000 400 000 477 000 537 000 4 000 000 2015 441 000 4 200 000 8 600 000 10 607 000 2 610 000 5 100 000 7 600 000 100 000 400 000 561 000 441 000 4 200 000 2016 418 000 4 400 000 10 100 000 11 924 000 3 009 000 5 200 000 9 100 000 200 000 400 000 653 000 418 000 4 400 000 2017 405 000 4 500 000 11 500 000 13 051 000 3 376 000 5 300 000 10 400 000 300 000 500 000 749 000 405 000 4 500 000 2018 351 000 4 700 000 12 400 000 13 941 000 3 538 000 5 300 000 11 400 000 400 000 500 000 843 000 351 000 4 700 000

Table A6. Volume of demand for APIs in metric tonnes: linear projection, 2014–2018 Drug d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTV

Demand for APIs (metric tonnes) based on the linear projection 2014 7 961 674 37 13 975 147 660 1254 133 16 39 2015 5 1094 908 45 16 1116 159 641 1645 138 24 45 2016 4 1150 1150 54 20 1278 161 596 2023 144 33 52 2017 5 1201 1356 65 23 1337 230 603 2327 183 30 63 2018 6 1243 1498 74 26 1288 362 675 2524 204 34 71

Table A7. Volume of demand for APIs in metric tonnes: country target projection, 2014–2018 Drug d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTV

Demand for APIs (metric tonnes) based on country target projection 2014 8 968 756 44 15 1092 164 740 1401 151 18 44 2015 7 1259 1159 62 21 1420 201 816 2084 178 31 58 2016 5 1515 1585 79 28 1733 218 810 2733 196 45 71 2017 7 1706 1980 108 36 1907 325 866 3304 264 44 93 2018 10 1886 2295 131 42 1920 536 1016 3745 306 53 112

Table A8. Volume of demand for APIs in metric tonnes based on CHAI projection, 2014–2018 Volume of demand for APIs metric (tonnes): CHAI based on patient projection 2014 d4T ZDV TDF 3TC FTC NVP EFV LPV ATV RTV 12 857 747 852 107 719 1303 117 8 32 2015 10 902 925 985 171 736 1632 123 15 36 2016 9 944 1093 1146 188 751 1961 129 22 40 2017 9 981 1237 1288 217 761 2247 135 30 44 2018 8 1010 1341 1410 243 760 2454 139 39 48

Drug

Table A9. Volume of demand for APIs in metric tonnes in sub-Saharan Africa based on the average of linear and country target projections, 2014–2018 Drug d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTV

Volume of demand for APIs (metric tonnes) in sub-Saharan Africa 2014 6 703 573 20 5 831 125 573 1085 82 9 24 2015 5 951 831 26 6 1035 147 602 1539 91 15 28 2016 3 1082 1099 31 7 1240 156 583 1968 97 20 32 2017 5 1177 1339 42 9 1342 230 610 2334 126 18 39 2018 7 1267 1517 50 10 1330 372 702 2597 146 20 45

Table A10. Volume of demand for APIs in metric tonnes in Latin America and the Caribbean based on the average of linear and country target projections, 2014–2018 Volume of demand for APIs (metric tonnes) in Latin America and the Caribbean 2014 d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTV 0.3 44 34 13 6 49 8 28 52 27 5 8 2015 0.3 54 50 17 8 52 7 29 73 31 7 12 2016 0.2 60 65 22 11 56 7 29 99 32 10 15 2017 0.3 65 77 27 13 63 11 31 120 41 11 20 2018 0.4 68 88 31 15 65 19 38 139 42 14 23

Drug

Table A11. Volume of demand for APIs in metric tonnes in the Eastern Mediterranean based on the average of linear and country target projections, 2014–2018 Drug d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTV

Volume of demand for APIs (metric tonnes) in the Eastern Mediterranean 2014 0 13 2 1 0.3 3 1 2 4 1 0 0 2015 0 4 4 1 0.4 4 1 2 6 1 0 0 2016 0 4 5 2 0.6 5 1 3 8 1 0 0 2017 0 5 6 2 0.7 6 1 3 9 2 0 0.5 2018 0 5 7 2 0.8 6 2 3 10 2 0 0.5

Table A12. Volume of demand for APIs in metric tonnes in Europe based on the average of linear and country target projections, 2014–2018 Drug d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTV

Volume of demand for APIs (metric tonnes) in Europe 2014 0.2 38 16 6 3 23 4 12 24 14 2 4 2015 0.1 26 24 8 4 28 4 13 32 18 3 6 2016 0.1 30 31 11 5 32 5 13 42 22 5 8 2017 0.1 32 38 13 6 34 6 13 51 31 5 12 2018 0.2 35 43 16 7 33 9 16 58 39 5 15

Table A13. Volume of demand for APIs in metric tonnes in South and South-East Asia based on the average of linear and country target projections, 2014–2018 Drug d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTV

Volume of demand for APIs (metric tonnes) in South and South-East Asia 2014 0.6 132 65 1 0.1 93 14 64 122 8 1 3 2015 0.5 104 90 1 0.1 105 15 61 156 9 2 3 2016 0.4 114 121 2 0.1 120 16 56 192 9 3 3 2017 0.6 127 150 3 0.1 125 22 56 219 11 3 3 2018 0.8 139 174 3 0.1 120 34 64 239 11 3 4

Table A14. Volume of demand for APIs in metric tonnes in the Western Pacific based on the average of linear and country target projections, 2014–2018 Drug d4T AZT TDF ABC ddI 3TC FTC NVP EFV LPV ATV RTV

Volume of demand for APIs (metric tonnes) in the Western Pacific 2014 0.3 43 23 1 0.2 33 5 21 40 9 1 3 2015 0.3 36 35 1 0.3 41 6 22 56 10 2 3 2016 0.2 42 48 1 0.4 48 6 20 70 11 3 4 2017 0.2 47 59 2 0.5 52 9 21 81 15 3 4 2018 0.3 51 68 2 0.6 51 15 25 92 17 3 5

Table A15. CHAI ARV formulation projections in person-years, 2014–2016 Product 3TC 10 mg/ml 3TC 150 3TC 300 ABC 20 mg/ml ABC 300 ABC 300 3TC 150 AZT 300 ABC 300 3TC 300 ABC 60 ABC 60 3TC 30 ABC 60 3TC 30 dispersible ABC 600 3TC 300 ATV 150 ATV 200 ATV 300 ATV/r 300/100 2014 76 644 694 472 696 191 82 061 48 254 – – 16 000 – 37 000 17 302 – – – 71 000 2015 74 082 706 521 746 490 99 955 43 852 – – 3000 – 32 000 15 641 – – – 131 000 2016 74 780 732 020 766 654 111 113 43 406 – – 4000 – 30 000 13 622 – – – 197 000

AZT 10 mg/ml AZT 100 AZT 300 AZT 300 3TC 150 AZT 300 3TC 150 EFV 600 AZT 300 3TC 150 NVP 200 AZT 60 3TC 30 AZT 60 3TC 30 NVP 50 d4T 12 3TC 60 d4T 12 3TC 60 NVP 100 d4T 15 d4T 20 d4T 30 d4t 30 3TC 150 (60 tab) d4t 30 3TC 150 NVP 200 d4T 6 3TC 30 d4T 6 3TC 30 NVP 50 ddI 125 ddI 200 ddI 25 ddI EC 250 ddl EC 400 DRV 300 DRV 600 EFV 200 EFV 50 EFV 600 ETV 100 ETV 200 IDV 400 LPV/r 100/25 LPV/r 200/50 LPV/r(80/20mg/ml) 60ml NVP 10mg/ml 100ml NVP 10mg/ml 240ml NVP 200

– – 266 000 967 000 – 1 979 000 6000 41 000 – – – – 152 000 54 000 181 000 30 000 11 000 12 000 27 000 12 000 3000 3000 – – 429 000 – 1 541 000 – – – 70 000 288 000 14 000 – – 2 066 000

– – 277 000 1 072 000 – 1 919 000 2000 49 000 – – – – 119 000 51 000 134 000 12 000 – 1000 8000 2000 3000 3000 – – 436 000 – 1 774 000 – – – 58 000 302 000 17 000 – – 2 246 000

– – 294 000 1 176 000 – 1 859 000 5000 36 000 – – – – 94 000 46 000 137 000 5000 8000 1000 – 1000 2000 3000 – – 447 000 – 1 899 000 – – – 49 000 315 000 10 000 – – 2 346 000

NVP 50 RAL 400 RTV 100 (60 tab) SQV 200 SQV 500 TDF 150 TDF 200 TDF 250 TDF 300 TDF 300 3TC 300 TDF 300 3TC 300 + ATV/r copack TDF 300 3TC 300 EFV 600 TDF 300 3TC 300 NVP 600 TDF 300 FTC 200 TDF 300 FTC 200 EFV 600 TDF 300 3TC 300 NVP 200

72 000 – – – – – – – 935 000 1 711 000 – 1 754 000 – 221 000 2 141 000

6000 – – – – – – – 1 023 000 2 047 000 – 2 705 000 – 199 000 2 383 000

6000 – – – – – – – 1 077 000 2 196 000 – 3 625 000 – 208 000 2 753 000

Table A16. Global Fund ARV formulation projections in person-years, 2015–2016 Product 3TC 10 mg/ml 3TC 150 3TC 300 ABC 20 mg/ml ABC 300 ABC 300 3TC 150 AZT 300 ABC 300 3TC 300 ABC 60 ABC 60 3TC 30 ABC 60 3TC 30 dispersible ABC 600 3TC 300 ATV 150 ATV 200 ATV 300 ATV/r 300/100 AZT 10 mg/ml 2015 2283 12 329 – 178 16 438 3699 – 2466 – 32 877 – 1644 4932 4932 80 548 6575 2016 2283 12 329 – 178 16 438 3699 – 2466 – 32 877 – 1644 4932 4932 100 685 6575

AZT 100 AZT 300 AZT 300 3TC 150 AZT 300 3TC 150 EFV 600 AZT 300 3TC 150 NVP 200 AZT 60 3TC 30 AZT 60 3TC 30 NVP 50 d4T 12 3TC 60 d4T 12 3TC 60 NVP 100 d4T 15 d4T 20 d4T 30 d4t 30 3TC 150 (60 tab) d4t 30 3TC 150 NVP 200 d4T 6 3TC 30 d4T 6 3TC 30 NVP 50 ddI 125 ddI 200 ddI 25 ddI EC 250 ddl EC 400 DRV 300 DRV 600 EFV 200 EFV 50 EFV 600 ETV 100 ETV 200 IDV 400 LPV/r 100/25 LPV/r 200/50 LPV/r(80/20mg/ml) 60ml NVP 10mg/ml 100ml NVP 10mg/ml 240ml NVP 200 NVP 50

5479 12 329 410 959 8219 863 014 45 205 133 562 – – – – – 1849 1233 4110 2055 82 658 1315 1644 2466 13 151 82 73 973 3082 394 521 1233 – – 27 397 120 822 3082 23 014 – 164 384 12 329

5479 12 329 410 959 8219 863 014 45 205 133 562 – – – – – 1849 1233 4110 2055 82 658 1315 1644 2466 13 151 82 73 973 3082 394 521 1233 – – 27 397 100 685 3082 23 014 – 164 384 12 329

RAL 400 RTV 100 (60 tab) SQV 200 SQV 500 TDF 150 TDF 200 TDF 250 TDF 300 TDF 300 3TC 300 TDF 300 3TC 300 + ATV/r copack TDF 300 3TC 300 EFV 600 TDF 300 3TC 300 NVP 600 TDF 300 FTC 200 TDF 300 FTC 200 EFV 600 TDF 300 3TC 300 NVP 200

– 4110 – – – – – 16 438 139 726 – 2 057 466 – 82 192 363 082 12 329

– 4110 – – – – – 16 438 139 726 – 2 033 260 – 82 192 871 397 12 329

Table A17. SCMS ARV formulation projections in person-years, 2015–2016 Product 3TC 10 mg/ml 3TC 150 3TC 300 ABC 20 mg/ml ABC 300 ABC 300 3TC 150 AZT 300 ABC 300 3TC 300 ABC 60 ABC 60 3TC 30 ABC 60 3TC 30 dispersible ABC 600 3TC300 ATV 150 ATV 200 ATV 300 ATV/r 300/100 AZT 10 mg/ml AZT 100 29 996 548 97 58 916 572 122 83 205 578 118 2014 1221 40 714 – 769 30 191 805 – 2294 32 616 11 925 49 869 12 157 2015 1238 41 752 – 752 25 780 984 – 2733 36 519 35 431 70 037 28 321 2016 1227 71 598 – 743 43 660 1 093 – 3097 52 428 60 899 84 809 31 360

AZT 300 AZT 300 3TC 150 AZT 300 3TC 150 EFV 600 AZT 300 3TC 150 NVP 200 AZT 60 3TC 30 AZT 60 3TC 30 NVP 50 d4T 12 3TC 60 d4T 12 3TC 60 NVP 100 d4T 15 d4T 20 d4T 30 d4t 30 3TC 150 (60 tab) d4t 30 3TC 150 NVP 200 d4T 6 3TC 30 d4T 6 3TC 30 NVP 50 ddI 125 ddI 200 ddI 25 ddI EC 250 ddl EC 400 DRV 300 DRV 600 EFV 200 EFV 50 EFV 600 ETV 100 ETV 200 IDV 400 LPV/r 100/25 LPV/r 200/50 LPV/r(80/20mg/ml) 60ml NVP 10mg/ml 100ml NVP 10mg/ml 240ml NVP 200 NVP 50 RAL 400

24 379 539 283 – 1 113 290 30 971 99 994 331 1935 1 5 608 5441 25 637 1741 6173 14 88 11 256 348 863 24 50 434 1532 505 292 18 11 9 10 432 138 845 37 015 4004 3978 629 754 5734 437

19 881 504 246 – 1 202 183 49 061 144 994 225 1280 – 3 612 2951 14 142 841 260 18 65 26 259 312 805 519 91 802 2562 402 302 170 – 13 16 117 222 959 33 285 5328 6573 368 914 7687 668

19 005 539 430 – 1 202 491 54 373 153 053 228 1196 – 3 611 2397 2438 908 243 21 70 23 255 306 1620 154 132 322 5001 425 414 98 16 15 19 537 214 079 31 208 5373 6380 379 559 10 397 881

RTV 100 (60 tab) SQV 200 SQV 500 TDF 150 TDF 200 TDF 250 TDF 300 TDF 300 3TC 300 TDF 300 3TC 300 + ATV/r copack TDF 300 3TC 300 EFV 600 TDF 300 3TC 300 NVP 600 TDF 300 FTC 200 TDF 300 FTC 200 EFV 600 TDF 300 3TC 300 NVP 200

1779 184 85 3515 3847

2297 184 190 6021 3983

3107 184 370 4498 23 384

10 841 741 249 1568 1 501 213 – 740 466 74 310 –

12 420 422 553 2566 3 354 548 – 416 599 76 406 –

19 010 452 808 1752 4 215 192 – 446 579 78 738 –

Fig. A1. Number of people receiving first- and second-line ART based on linear projection, 2013–2018 25 20 15 Millions 10 5 0 2013 Children SL Children FL Adult SL Adult FL 30 000 710 000 560 000 10 400 000 2014 40 000 700 000 740 000 11 800 000 2015 40 000 750 000 860 000 13 400 000 2016 40 000 800 000 980 000 15 000 000 2017 50 000 840 000 970 000 16 400 000 2018 50 000 880 000 1 100 000 17 800 000

Fig. A2. Number of people receiving first- and second-line ART based on country target projection, 2013–2018 35 30 25 Millions 20 15 10 5 0 2013 Children SL Children FL Adult SL Adult FL 30 000 700 000 560 000 10 400 000 2014 60 000 1 100 000 90 000 14 200 000 2015 70 000 1 200 000 1 100 000 17 500 000 2016 80 000 1 400 000 1 300 000 20 700 000 2017 100 000 1 800 000 1 600 000 23 600 000 2018 100 000 2 000 000 1 800 000 26 700 000

Fig. A3. Number of people receiving first- and second-line ART based on CHAI data, 2013–2018 25 20 15 Millions 10 5 0 2013 Children SL Children FL Adult SL Adult FL 30 000 700 000 600 000 10 400 000 2014 40 000 800 000 600 000 12 100 000 2015 40 000 900 000 700 000 13 800 000 2016 50 000 900 000 800 000 15 400 000 2017 60 000 1 000 000 900 000 16 700 000 2018 60 000 1 100 000 1 000 000 17 500 000

Fig. A4. Number of people receiving first- and second-line ART in sub-Saharan Africa based on the average of linear and country target projections, 2013–2018 22 20 18 16 14 Millions 12 10 8 6 4 2 0 2013 Children SL Children FL Adult SL Adult FL 30 000 490 000 430 000 8 100 000 2014 40 000 780 000 560 000 10 200 000 2015 50 000 850 000 690 000 12 200 000 2016 60 000 940 000 830 000 14 200 000 2017 70 000 1 200 000 970 000 16 000 000 2018 80 000 1 300 000 1 100 000 17 800 000

Fig. A5. Number of people receiving first- and second-line ART in Latin America and the Caribbean based on the average of linear and country target projections, 2013–2018 1.8 1.6 1.4 1.2 Millions 1.00 0.08 0.06 0.04 0.02 0.00 2013 Children SL Children FL Adult SL Adult FL 1 000 19 000 40 000 760 000 2014 1 500 29 000 50 000 950 000 2015 1 600 30 000 60 000 1 100 000 2016 1 800 33 000 68 000 1 300 000 2017 2 100 39 000 70 000 1 300 000 2018 2 200 42 000 77 000 1 500 000

Fig. A6. Number of people receiving first- and second-line ART in the Eastern Mediterranean based on the average of linear and country target projections, 2013–2018 90 80 70 60 Thousands 50 40 30 20 10 0 2013 Children SL Children FL Adult SL Adult FL 50 1 000 1 600 30 000 2014 90 1 700 2 100 40 000 2015 100 1 900 2 700 50 000 2016 120 2 300 3 100 58 000 2017 140 2 700 3 500 66 000 2018 160 2 900 3 900 73 000

Fig. A7. Number of people receiving first- and second-line ART in Europe based on the average of linear and country target projections, 2013–2018 700 600 500 Thousands 400 300 200 100 0 2013 Children SL Children FL Adult SL Adult FL 450 8 600 13 000 240 000 2014 650 12 000 18 000 330 000 2015 700 13 000 21 000 400 000 2016 800 15 000 25 000 470 000 2017 960 18 000 28 000 540 000 2018 1 100 20 000 32 000 600 000

Fig. A8. Number of people receiving first- and second-line ART in South and South-East Asia based on the average of linear and country target projections, 2013–2018 2.0 1.8 1.6 1.4 Millions 1.2 1.00 0.08 0.06 0.04 0.02 0.00 2013 Children SL Children FL Adult SL Adult FL 2 800 52 000 55 000 1 000 000 2014 3 200 60 000 55 000 1 000 000 2015 3 600 68 000 65 000 1 200 000 2016 4 100 77 000 75 000 1 400 000 2017 4 700 89 000 80 000 1 500 000 2018 5 200 99 000 90 000 1 700 000

Fig. A9. Number of people receiving first- and second-line ART in the Western Pacific based on the average of linear and country target projections, 2013–2018 1400 1200 1000 Thousands 800 600 400 200 0 2013 Children SL Children FL Adult SL Adult FL 1 700 31 000 35 000 790 000 2014 1 900 35 000 40 000 800 000 2015 2 100 39 000 47 000 900 000 2016 2 300 43 000 50 000 1 000 000 2017 2 600 49 000 55 000 1 000 000 2018 2 900 54 000 65 000 1 200 000

For more information, contact: World Health Organization Department of HIV/AIDS 20, avenue Appia 1211 Geneva 27 Switzerland E-mail: hiv-aids@who.int www.who.int/hiv

ISBN 978 92 4 150915 2

Основные сведения

Организация Всемирная организация здравоохранения (ВОЗ / WHO)

Тип документа Publications

Дата принятия 10 июля 2015 г.

Источник Всемирная организация здравоохранения