GREGG ALTON, Gilead Sciences, Inc.

Lead Author: Gregg Alton
Organization: Gilead Sciences, Inc.
Country: USA

Abstract 

Gilead Sciences, Inc.
Contribution Submission
UN High-Level Panel on Access to Medicines

Gilead Sciences, Inc. and the UN High-Level Panel on Access to Medicines share a commitment to upholding human rights and delivering innovative medicines to patients around the world. Gilead’s unique approach enables timely access to affordable, high-quality medicines, particularly in the developing world. Today, 865,000 patients in the United States and Europe and 8.7 million patients in the developing world receive Gilead HIV medicines. Since 2013, 770,000 patients have received Gilead’s hepatitis C medicines globally - 200,000 of whom live in low- and middle-income countries. Gilead works with governments and other payers around the world to determine appropriate pricing for its medicines based on a country’s:

• economic means
• disease prevalence
• willingness to invest in broad patient access across all subpopulations

We recommend the Panel consider the access approach we outline in our submission– specifically partnership with governments, tiered pricing, support services, and voluntary licensing – as effective ways to address the interests and objectives of patients, civil society, governments and innovator companies by advancing the public health and human rights goal of ensuring broad access to medicines to patients regardless of where they live or their economic status, while incentivizing innovation.

Submission

Gilead Sciences, Inc.
Contribution Submission
UN High-Level Panel on Access to Medicines

Introduction

Gilead Sciences, Inc. and the UN High-Level Panel on Access to Medicines share a commitment to upholding human rights and delivering innovative medicines to patients around the world. Gilead’s unique approach enables timely access to affordable, high-quality medicines, particularly in the developing world. Today, 865,000 patients in the United States and Europe and 8.7 million patients in the developing world receive Gilead HIV medicines. Since 2013, 770,000 patients have received Gilead’s hepatitis C medicines globally - 200,000 of whom live in low- and middle-income countries. Gilead works with governments and other payers around the world to determine appropriate pricing for its medicines based on a country’s:

• economic means
• disease prevalence
• willingness to invest in broad patient access across all subpopulations

We recommend the Panel consider the access approach we outline below – specifically partnership with governments, tiered pricing, support services, and voluntary licensing – as effective ways to address the interests and objectives of patients, civil society, governments and innovator companies by advancing the public health and human rights goal of ensuring broad access to medicines to patients regardless of where they live or their economic status, while incentivizing innovation.

About Gilead

Gilead is a research-based biopharmaceutical company with headquarters in Foster City, California, that discovers and develops medicines for people living with life-threatening illnesses. The company’s main therapeutic areas include antiretroviral (ARV) treatments for HIV and hepatitis B virus (HBV), and antivirals for hepatitis C virus (HCV) infection.

HIV/AIDS

Nearly 37 million people live with HIV/AIDS worldwide. Gilead’s portfolio of HIV medicines includes several category firsts such as complete HIV treatment regimens in a once-daily pill and the first oral pill to reduce the risk of acquiring HIV in certain high-risk adults. The active ingredient in Gilead’s HIV medicines, tenofovir disoproxil fumarate (TDF), is the most widely prescribed molecule for HIV therapy worldwide. Gilead continues to innovate to meet the evolving needs of HIV patients. Gilead has made exciting progress with regimens containing tenofovir alafenamide (TAF), which have demonstrated high antiviral efficacy and an improved renal and bone safety profile.

Hepatitis C

The World Health Organization (WHO) estimates that more than 170 million people worldwide are infected with HCV, which can cause serious liver disease including cirrhosis, cancer and liver failure. Gilead’s new HCV therapies, Sovaldi® (sofosbuvir) and Harvoni® (ledipasvir/sofosbuvir), are breakthrough direct-acting antivirals. In both clinical trials and real-world settings, Sovaldi and Harvoni regimens were shown to cure, on average, more than 90 percent of patients with HCV infection. They are more effective than the prior standard of care, which offered average cure rates of 50 percent. They are also safer, more tolerable, easier to administer and completed in a shorter period of time (as few as 8 weeks vs. up to 48 weeks). Gilead remains focused on advancing care for HCV patients with its investigational regimen, sofosbuvir/velpatasvir, which has the potential to cure patients, regardless of genotype.

Ensuring Access in the Developed World

In the U.S., Europe and other high-income countries, Gilead works to ensure broad access to its medicines through strong partnerships with payers, including governments, as well as through patient assistance programs. Recognizing that there are competing demands on healthcare systems, Gilead endeavors to deliver its medicines in a way that is economically sustainable and respects healthcare budgets.
United States

HIV/AIDS

Approximately half of all patients taking Gilead HIV medicines in the U.S. receive them through federal and state programs at substantially discounted prices. Gilead has worked with state AIDS Drug Assistance Programs (ADAPs) to provide pricing for its HIV medicines lower than required by legally mandated discounts. In 2008, the company instituted a voluntary price freeze and additional discounts for ADAPs for all Gilead HIV products that will continue through 2016. Gilead also established U.S. patient assistance programs, which help make Gilead HIV therapies accessible for uninsured individuals and those who need financial assistance.

Hepatitis C

Despite the significant advancement (i.e., high cure rates, shorter treatment duration) that Gilead’s new HCV treatments offer, Sovaldi and Harvoni are responsibly priced at parity with older, less effective treatments. Gilead conducted extensive research with public and private payers to establish a price that would permit broad patient access. The Wyden-Grassley Senate Committee on Finance expressed the opinion that Gilead priced Sovaldi to maximize profits. However, as source documents included in the report indicate, Gilead priced Sovaldi with a strong focus on access – not profit maximization -- considering guidance received from payers.

To date, approximately ten percent of patients infected with HCV in the U.S. have been treated with a sofosbuvir-based regimen. Approximately 60 percent of patients receive treatment through federal and state programs, all of which receive substantial discounts off U.S. list prices. Payers like Medicaid and Veterans Affairs (VA), for example, receive discounts in excess of 50 percent on Harvoni. An estimated 25 percent of HCV-infected patients in the VA population have been treated to date. Gilead continues to partner with Medicaid and the VA and to identify innovative, value-based arrangements that ensure access to all patients, not just those with advanced liver disease.

To help ensure eligible HCV patients in the U.S. have access to Harvoni and Sovaldi, Gilead established the Support Path® program. Through this program, the majority of commercially insured patients are able to access Harvoni and Sovaldi for a five dollar (USD) co-pay per month. And for eligible patients with no insurance, the Support Path Patient Assistance Program provides Harvoni and Sovaldi at no charge.

Europe

As with other developed countries, Gilead has negotiated pricing agreements in European markets, taking into account each country’s economic means, burden of disease and commitment to investing in HIV and HCV patient access. With the availability of more effective HCV treatments, several countries have significantly increased their treatment rates. France, for example, treated 6,000 HCV patients in 2013, increasing to 14,000 in 2015. The rate of reimbursement for HCV treatments has also been impressive – within one year of European regulatory approval, Harvoni is reimbursed in 23 of the 28 EU member states, including Bulgaria, Slovakia, and Slovenia.

Political will is critical to increasing the number of patients receiving treatment. Some national authorities have used innovative financing arrangements to reach ambitious treatment goals. One approach – volume discounts – significantly reduces treatment costs and incentivizes wider patient access by encouraging governments to treat all HCV patients, not just those with advanced disease. For example:

• Spain: In July 2015, Spain’s health ministry published a national strategic plan to combat HCV, and their finance ministry established regional loans to fund treatment. To date, over 40,000 patients have been treated through the program at a significantly discounted price – far exceeding the original commitment.
• Portugal: The Portuguese government has established a dedicated funding line for HCV treatment. An estimated 6,000 people, regardless of disease progression, have been treated to date at a significantly discounted price. This represents a six-fold increase over previous treatment rates.
• Italy: As of January 2016, 32,500 patients have initiated HCV treatment as a result of a national pricing agreement that incentivizes broad access – more than double the historic HCV treatment rate.

Australia

More than 230,000 Australians are living with HCV. The Australian government is investing $1 billion over five years to make new HCV medicines available to all patients, regardless of disease progression.

Ensuring Access in the Developing World

Over the past 13 years, Gilead has developed a pioneering access approach that has helped support the rapid scale-up of HIV/AIDS treatment in the developing world. Today, Gilead has adopted a similar model to make its HCV medicines available at a more accelerated pace.

The access approach in the developing world consists of: 1) discounts on branded medicines based on a country’s Gross National Income per capita, disease burden and willingness to invest in broad HIV and HCV patient access across all populations, especially vulnerable groups; and 2) voluntary licensing of Gilead’s innovative medicines to generic drug companies (both directly and through the UN-backed Medicines Patent Pool), which can set their own prices and sell the medicines in a defined number of low- and middle-income countries. Success is measured, not by revenue but by the breadth of access achieved in a geographic region, as well as by improved public health outcomes.

Gilead also works closely with local governments, non-governmental organizations (NGOs), businesses and medical communities to register products, provide medical and clinical education, forecast demand to prevent shortages or stock-outs and conduct collaborative research. In total, Gilead works with more than 30 manufacturers, regional and local distributors and generic licensees to expand access to its medicines, including those currently in the company’s R&D pipeline.

Gilead’s approach in the developing world has been shaped by over a decade of experience and adaption. The following is an overview of Gilead’s access model’s evolution over time.

2003-2004

In 2003 and 2004, Gilead made two of its HIV medicines -- Viread® (TDF) and Truvada® (TDF/FTC) – available at no-profit pricing in 68 countries. Since the company had no manufacturing facilities or drug registrations outside the developed world, Gilead shipped its medicines directly from North American and European facilities to partner organizations in developing countries. Import permits granted by national health ministries allowed limited quantities of medicines to go to specific organizations or patients. Despite an ambitious vision, this initial approach reached very few patients.

2005

In 2005, Gilead increased the number of developing countries receiving price reductions to 97. The company also stopped using import permits, which were not sufficiently flexible to ensure efficient delivery of medicines. To avoid a lengthy country-by-country registration process, Gilead submitted a single registration dossier to approximately 50 countries. The company also submitted its HIV medicines for WHO pre-qualification. While these measures led to improvements, only 30,000 patients were receiving Gilead HIV medicines by the end of 2005, and only one country responded to the regulatory dossier with an approval.

2006-2011

In 2006, Gilead overhauled its access approach, establishing a team separate from the company’s commercial operations. This team laid the foundations of Gilead’s current approach by establishing voluntary licensing agreements with generic drug manufacturers in India. These companies were free to brand, price and differentiate themselves in a competitive market. Under the agreements, the licensees could sell generic TDF in 95 countries–later expanding to 112 countries.

Gilead also assembled a portfolio of support activities, including tackling the lengthy process of registering medicines. Gilead identified business partners to build a sophisticated distribution network, and also engaged in medical education and supply chain management.

2011-present

As Gilead continued to innovate, it incorporated its newer medicines under the access model, including the once-daily single tablet regimen Stribild®. The company also supported new mechanisms to enable access, such as the Medicines Patent Pool (MPP). Gilead was the first innovator pharmaceutical company to join the MPP.

In 2014 and 2015, Gilead expanded its MPP licensing agreements by granting generic manufacturers in India, China and South Africa future rights to develop the investigational compound TAF for HIV and HBV treatment in 112 resource-limited countries, contingent on the medicine’s U.S. regulatory approval. Today, Gilead licenses TDF, TDF-containing regimens and TAF through the MPP.

Starting in September 2014, Gilead extended and adapted its access model to include its HCV medicines, Sovaldi and Harvoni. Gilead developed the following access strategy for HCV:

• Single lowest branded price in generic territory: In 101 countries, which represent more than half of the global HCV burden, Gilead-branded Sovaldi is available at $900 per treatment course and, in combination with other therapies, offers a cure for the vast majority of patients. Harvoni is available at $1,200 per treatment course and has even higher cure rates (93 – 99 percent).
• Preferential pricing: In other middle-income countries, prices are determined on a country-by-country basis, following negotiations with governments.
• Licensed generics: Voluntary licensing agreements allow licensees to manufacture and distribute generic versions of Gilead’s medicines to the same 101 developing countries referenced above. Licensees pay a modest royalty to Gilead, which is reinvested to ensure sustainability of the program.
• Product registration and business partnerships: Gilead engages with regional partners to register medicines with regulatory authorities, coordinate distribution, conduct safety reporting and track inventory to prevent supply disruptions.
• Research:
- Clinical Trials: Gilead collaborates with regulatory authorities, NGOs and local thought leaders to carry out clinical trials in diverse patient populations. Clinical studies are completed or ongoing in countries that require local trials for product approval, including China, India, Russia and Vietnam. Additional studies to address local unmet medical needs and generate in-country data are ongoing or planned in Brazil, Cameroon, Egypt, India, Ivory Coast, Malaysia, Mexico, Rwanda, Senegal and Thailand.
- Demonstration projects: Gilead supports numerous in-country research programs and demonstration projects, including a pilot program in Ukraine providing HCV treatment to injecting drug users and other affected populations. Gilead is also piloting linkage-to-care models in resource-limited settings, with a focus on point-of-care diagnostics, task shifting and innovative health financing.

Progress to Date

HIV/AIDS

As of January 2016, nearly two-thirds – 8.7 million – of the 13.5 million people in the developing world receiving HIV treatment are on Gilead therapies. Driven by competition among generic manufacturers holding voluntary licenses, the cost of Gilead’s HIV medicines in these regions has fallen by more than 80 percent since 2006. Generic versions of Gilead’s Viread are available for as little as $42 per patient per year in the developing world.

Hepatitis C

Gilead works concurrently to make both branded and generic versions of its products available as quickly as possible. Gilead licensed Sovaldi to generic manufacturers within one year of its U.S. approval. Harvoni was also included in the licensing agreement at that time – prior to its U.S. regulatory approval. To date, roughly 10 percent of HCV patients receiving treatment in developing countries are taking generic versions of Gilead’s medicines, and some generic prices have dropped to approximately $360 per three month treatment course. Sovaldi has been approved in 16 developing countries and dossiers have been filed in 13 others. Harvoni is approved in five developing countries and dossiers have been filed in 14 others.

Additionally, Gilead is working with countries and regions to expedite HCV treatment scale-up.

• Egypt: Egypt has the highest prevalence of HCV in the world - as much as 15 percent. Gilead has partnered with the Ministry of Health to implement an ambitious HCV treatment program. Gilead provides branded Sovaldi at its lowest branded price and supports the health ministry’s medical education and prevention efforts. Since October 2014, more than 135,000 Egyptians have begun treatment with Sovaldi.
• Pakistan: Pakistan has one of the highest HCV burdens. Sovaldi is also available in Pakistan at the lowest branded price and since February 2015, 45,000 patients have initiated treatment.
• Georgia: Georgia has the world’s third-highest HCV prevalence (7%). Gilead is partnering with Georgia’s Ministry of Health and the U.S. Centers for Disease Control and Prevention to eliminate HCV in the country. The partnership aims to demonstrate the impact of widespread HCV screening and universal treatment. Gilead is donating Sovaldi and Harvoni, and 5,250 people have initiated treatment to date.
• Latin America: In November 2015, following negotiations with MERCOSUR, Gilead agreed to provide Sovaldi at its lowest price in the region to Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guyana, Paraguay, Peru, Suriname, Uruguay and Venezuela.
• Brazil: An estimated two million people are infected with HCV in Brazil. Gilead has reached an agreement with the Ministry of Health to provide Sovaldi through the national public health system. The ministry has committed to scaling-up treatment nearly threefold.

Although the number of patients receiving affordable, quality HCV treatment has increased, there are many more patients in need of treatment. Gilead is working with donor organizations, country governments and development banks to address a significant barrier to access– health financing. Gilead is exploring creative approaches to secure funding for HCV including loans, innovative financing mechanisms and employer test-treat-cure programs.

Gilead and Agenda 2030

Agenda 2030 urges United Nations member states to accelerate the pace of progress in fighting epidemics, including HIV/AIDS and viral hepatitis. It also calls for a revitalized global partnership for sustainable development, including the involvement of the private sector. For more than a decade, Gilead has worked toward these goals, in partnership with stakeholders, and developed access initiatives that are both bold enough to improve public health and fiscally sustainable, offering an example for others to replicate and adapt. Gilead will continue to adapt and evolve its approach to ensure patients have access to its innovations, regardless of where they live or their economic status.

Bibliography and References

Gilead Sciences, Inc.
Contribution Submission
UN High-Level Panel on Access to Medicines

Endnotes

i. In December 2013, the FDA approved Gilead’s Sovaldi for the treatment of patients with chronic infection with HCV genotypes 1, 2, 3 and 4 in combination with ribavirin and, depending on genotype, interferon. The Sovaldi regimen offers patients a short-duration course of treatment with a high cure rate. In October 2014, the FDA approved Gilead’s Harvoni to treat patients with HCV genotype 1. Harvoni, which combines Sovaldi with Gilead’s NS5A inhibitor ledipasvir, is the first and only HCV treatment to provide a complete regimen and potential cure in one tablet taken once daily, without interferon or ribavirin. Patients take Harvoni for eight, 12 or 24 weeks. In November 2015, the FDA expanded use of Harvoni to include patients with genotypes 4, 5 and 6 and patients co-infected with HIV. Harvoni in combination with ribavirin for 12 weeks can be considered for treatment-experienced genotype 1 patients with cirrhosis. In global guidelines published in 2014, the World Health Organization (WHO) recommended Sovaldi to treat HCV genotypes 1, 2, 3 and 4 prescribed in combination with ribavirin and, depending on genotype, interferon.

ii. HCV is classified by genotype, and the prevalence (number of people infected) of each of six genotypes and subtypes varies by country. The diversity of genotypes requires different treatment approaches and different drug regimens.

iii. Gilead’s HIV/AIDS patient assistance programs include: U.S. Advancing Access®; Atripla® Patient Access Program; and Truvada® for PrEP Medication Assistance Program.

iv. List prices serve as a starting point for payer negotiations in the U.S. All payers in the United States have received a discount to date.

v. Spain’s original commitment was to treat 52,000 over a three year period.

vi. Stribild (TDF/FTC/COBI/EVG)

vii. Gilead joined the MPP in 2011.

viii. These estimates are based on suggested public/government prices of USD $300 per bottle of Sovaldi and $400 per bottle of Harvoni. One bottle is the equivalent of one month of treatment. The cost per treatment course estimate is based on a three month treatment duration - $900 for three months of Sovaldi and $1,200 for three months of Harvoni. Treatment duration can vary from patient to patient depending on hepatitis C genotype, current health status and past treatment experience. A full course of treatment with Sovaldi, in combination with other therapies, or Harvoni represents a cure for the majority of patients (average 90% cure rate for Sovaldi and 93 – 99% cure rate for Harvoni). Cost per treatment course estimates do not include the cost of diagnostics, monitoring or additional medicines, such as interferon and/or ribavirin. Costs can vary country-by-country depending on the exchange rate.

ix. Harvoni received U.S. regulatory approval in December 2014.

x. This estimate is based on a publicized price of USD $120/bottle of generic Sovaldi (sofosbuvir). One bottle is the equivalent of one month of treatment. The cost per treatment course estimate is based on a three month treatment duration - $360 for three months of generic sofosbuvir. Treatment duration can vary from patient to patient depending on hepatitis C genotype, current health status and past treatment experience. Cost per treatment course estimates do not include the cost of diagnostics, monitoring or additional medicines, such as interferon and/or ribavirin. Costs can vary country-by-country depending on the exchange rate.

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HIV

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• U.S. Food and Drug Administration Approves Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection. Gilead Press Release, November 5, 2015. Available here: https://www.gilead.com/news/press-releases/2015/11/us-food-and-drug-administration-approves-gileads-single-tablet-regimen-genvoya-elvitegravir-cobicistat-emtricitabine-and-tenofovir-alafenamide-for-treatment-of-hiv1-infection.

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Medicines Patent Pool

• Medicines Patent Pool Announces First Licensing Agreement with a Pharmaceutical Company. Medicines Patent Pool Press Release, July 12, 2011. Available here: http://www.medicinespatentpool.org/medicines-patent-pool-announces-first-licensing-agreement-with-a-pharmaceutical-company/.

• UN welcomes pact to improve access of patented AIDS drugs in poor countries. United Nations Statement, July 12, 2011. Available here: http://www.un.org/apps/news/story.asp?NewsID=39018#.Vs9TZvkrIy5.

• Gilead Expands Access Program for Medications in Developing World. Gilead Sciences Press Release, July 12, 2011. Available here: http://gilead.com/news/press-releases/2011/7/gilead-expands-access-program-for-medications-in-developing-world.

• Gilead Announces New Agreement with Medicines Patent Pool for Access to Medicines in Developing World Countries. Gilead Sciences Press Release, July 24, 2014. Available here: http://www.gilead.com/news/press-releases/2014/7/gilead-announces-new-agreement-with-medicines-patent-pool-for-access-to-medicines-in-developing-world-countries.

• The Medicines Patent Pool (MPP) Broadens Collaboration with Gilead Sciences: Signs Licence for Phase III Medicine Tenofovir Alafenamide (TAF), Medicines Patent Pool Press Release, July 24, 2014, Available here: http://www.medicinespatentpool.org/the-medicines-patent-pool-mpp-broadens-collaboration-with-gilead-sciences-signs-licence-for-phase-iii-medicine-tenofovir-alafenamide-taf/.

• The Medicines Patent Pool and Gilead Sciences Expand Licence to Allow Generic Manufacture of Medicines in South Africa. Medicines Patent Pool Press Release, June 11, 2015. Available here: http://www.medicinespatentpool.org/the-medicines-patent-pool-and-gilead-sciences-expand-licence-to-allow-generic-manufacture-of-medicines-in-south-africa/.

• Current list of Medicines Patent Pool Licenses. Medicines Patent Pool, Last accessed February 13, 2016. Accessible here: http://www.medicinespatentpool.org/current-licences/.

Hepatitis C

• U.S. Food and Drug Administration Approves Gilead’s Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C. Gilead Sciences Press Release, December 6, 2013. Available here: http://gilead.com/news/press-releases/2013/12/us-food-and-drug-administration-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-chronic-hepatitis-c.

• Gilead Announces Generic Licensing Agreements to Increase Access to Hepatitis C Treatments in Developing Countries. Gilead Sciences Press Release, September 15, 2014. Available here: http://www.gilead.com/news/press-releases/2014/9/gilead-announces-generic-licensing-agreements-to-increase-access-to-hepatitis-c-treatments-in-developing-countries.

• KEI welcomes the Gilead HCV licenses, as a step to expand access to treatments. Notes challenges that remain. Knowledge Ecology International. September 15, 2014. Available here: http://keionline.org/node/2082.

• Gilead Briefs Nirmala Sitharaman About Their Licensing Agreements With Seven India Based Generic Pharmaceutical Manufacturers. Government of India Ministry of Commerce and Industry Press Release, September 17, 2014. Available here: http://commerce.nic.in/pressrelease/pressrelease_detail.asp?id=3119.

• U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C, Gilead Sciences Press Release, October 10, 2014. Available here: http://gilead.com/news/press-releases/2014/10/us-food-and-drug-administration-approves-gileads-harvoni-ledipasvirsofosbuvir-the-first-oncedaily-single-tablet-regimen-for-the-treatment-of-genotype-1-chronic-hepatitis-c

• Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent. Gilead Sciences Press Release, January 26, 2015. Available here: https://www.gilead.com/news/press-releases/2015/1/gilead-expands-hepatitis-c-generic-licensing-agreements-to-include-investigational-pangenotypic-agent.

• Gilead Targets Elimination of Hepatitis C. WIPO Magazine, February 2015. Available here: http://www.wipo.int/wipo_magazine/en/2015/01/article_0001.html.

• Gilead: Hepatitis-C Access Strategy (A). Harvard Business Review, October 2014 (Revised July 2015). Available here: http://www.hbs.edu/faculty/Pages/item.aspx?num=48208.

• Gilead: Hepatitis-C Access Strategy (B). Harvard Business Review, October 2014 (Revised July 2015). Available here: http://www.hbs.edu/faculty/Pages/item.aspx?num=48211.

• Gilead Announces SVR12 Rates from Four Phase 3 Studies Evaluating a Once-Daily, Fixed-Dose Combination of Sofosbuvir (SOF) and Velpatasvir (VEL) (GS-5816) for the Treatment of All Six Hepatitis C Genotypes. Gilead Press Release, September 21, 2015. Available here: http://www.gilead.com/news/press-releases/2015/9/gilead-announces-svr12-rates-from-four-phase-3-studies-evaluating-a-oncedaily-fixeddose-combination-of-sofosbuvir-sof-and-velpatasvir-vel-gs5816-for-the-treatment-of-all-six-hepatitis-c-genotypes. .

• Chronic Hepatitis C Treatment Expansion: Generic Manufacturing for Developing Countries. Gilead Sciences, Last updated October 2015. Available here: http://gilead.com/~/media/files/pdfs/other/hcv%20generic%20agreement%20fast%20facts%20101615.pdf.

• Expanding Chronic Hepatitis C Treatment in Low- and Middle-Income Countries. Gilead Sciences, October 2015. Available here: http://gilead.com/~/media/files/pdfs/other/hcv%20access%20fact%20sheet%20%20101615.pdf.

Sustainable Development Goals

• “The scale and ambition of the new Agenda requires a revitalized Global Partnership to ensure its implementation. We fully commit to this…It will facilitate an intensive global engagement in support of implementation of all the Goals and targets, bringing together Governments, the private sector, civil society, the United Nations system and other actors and mobilizing all available resources.” Agenda 2030, paragraph 39. United Nations, September 2015. Available here: https://sustainabledevelopment.un.org/content/documents/21252030%20Agenda%20for%20Sustainable%20Development%20web.pdf.

Australia

• Turnbull Government Invests over $1 billion to Cure HEP C. Australian Ministry for Health, December 20, 2015. Available here: https://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2015-ley154.htm.

• New Hepatitis C medicines – Factsheet for patients and consumers. Turnbull Government, December 2015. Available here: https://www.health.gov.au/internet/ministers/publishing.nsf/Content/FAE2B65331456243CA257F20006D4C48/$File/Hepatitis%20C%20Factsheet%20for%20patients%20and%20consumers.pdf.

Brazil

• Ministry of Health to offer innovative treatment for Hepatitis C. Brazil Department of STD, AIDS, and Viral Hepatitis, June 17, 2015. Available here: http://www.aids.gov.br/en/noticia/2015/ministry-health-offer-innovative-treatment-hepatitis-c.

Egypt

• Plan of Action for the Prevention, Care & Treatment of Viral Hepatitis, Egypt 2014-2018. Egyptian Ministry of Health and Population. Available here: http://www.emro.who.int/images/stories/egypt/VH_Plan_of_Action_FINAL_PRINT1.pdf.

France

• How to improve access to therapy in France? Presentation by Victor De Ledinghen at the Paris Hepatitis Conference, January 11, 2016. Available here: http://www.aphc.info/wp-content/uploads/2016/01/PHC_2016.pdf.

Georgia

• California Biopharmaceutical Company Signs Historic Agreement to Eliminate Hepatitis C in Georgia (April 21), Embassy of the United States to Georgia News, April 21, 2015. Available here: http://georgia.usembassy.gov/news-events/emb_news2015t/21042015c.html/.

• Hepatitis C Treatments Will Be Free In Georgia, Prime Minister of Georgia Press Release, April 21, 2015. Available here: http://gov.ge/index.php?lang_id=ENG&sec_id=412&info_id=48577.

Italy

• The Italian Payers’ approach to new anti-hepatitis C drugs. Italian Medicines Agency Statement, April 9, 2015. Available here: http://www.epac.it/notizie/default.asp?id=890&id_n=14877.

Portugal

• Portugal agrees to treat 13,000 Hepatitis C sufferers for free. Digital Journal, February 8, 2015. Available here: http://www.digitaljournal.com/life/health/portugal-agrees-to-treat-13-000-hepatitis-c-sufferers-for-free/article/425590.

• Balanço do programa da Hepatite C. Infarmed: Autoridade Nacional do Medicamento e Produtos de Saude I.P. Press Release, July 28, 2015. Available here: http://www.infarmed.pt/portal/pls/portal/docs/1/11154356.PDF.

• Reunião do Ministério da Saúde com os hospitais do SNS - Hepatite C. Infarmed: Autoridade Nacional do Medicamento e Produtos de Saude I.P. Press Release, February 18, 2015. Available here: http://www.infarmed.pt/portal/page/portal/INFARMED/MAIS_NOVIDADES/DETALHE_NOVIDADE?itemid=10427427.

• Hepatite C – Monitorização dos tratamentos. Infarmed: Autoridade Nacional do Medicamento e Produtos de Saude I.P. Data released, February 22, 2016. Available here: http://www.infarmed.pt/portal/page/portal/SOBRE_O_INFARMED/ESTRUTURA_E_ORGANIZACAO/CTE/Comissao_Nacional_de_Farmacia_Terapeutica/FNM/HepC_Monitorizacao_29Set2015.pdf.

• “Impact of the Universal Drug Coverage Program to Eradicate the Burden of Hepatitis C in Portugal.” AASLD 2016 abstract presented by Eurico C. Alves.

Spain

• Plan Estratégico Para El Abordaje De La Hepatitis C En El Sistema Nacional De Salud. Miniserio De Sanidad, Servicios Sociales e Igualdad, May 21, 2015. Available here: http://www.msssi.gob.es/ciudadanos/enfLesiones/enfTransmisibles/docs/plan_estrategico_hepatitis_C.pdf

• Más de 40.000 pacientes de Hepatitis C han recibido tratamiento en España desde el 1 de enero de 2015 con medicamentos de última generación. Press Release from Miniserio De Sanidad, Servicios Sociales e Igualdad, February 23, 2016. Available here: http://www.msssi.gob.es/gabinete/notasPrensa.do?id=3909.

United States

• Gilead Sciences and ADAP Crisis Task Force Announce New Initiatives to Support AIDS Drug Assistance Programs (ADAPs). Gilead Sciences Press Release, June 4, 2010. Available here: http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1434629#sthash.giMqQhLr.dpuf

• The Price of Sovaldi and its Impact on the U.S. Health Care System. United States Senate Committee on Finance, December 1, 2015. Available here: http://www.finance.senate.gov/imo/media/doc/1%20The%20Price%20of%20Sovaldi%20and%20Its%20Impact%20on%20the%20U.S.%20Health%20Care%20System%20(Full%20Report).pdf.

• U.S. Patient Access. Gilead Sciences website, accessed February 25, 2016. Available here: http://gilead.com/responsibility/us-patient-access.

• U.S. Advancing Access. Gilead Sciences website, accessed February 25, 2016. Available here: http://gilead.com/responsibility/us-patient-access/us%20advancing%20access.

• Atripla Patient Access Program. Gilead Sciences website, accessed February 25, 2016. Available here: http://gilead.com/responsibility/us-patient-access/atripla%20patient%20access%20program.

• Truvada for PrEP Medication Assistance Program. Gilead Sciences website, accessed February 25, 2016. Available here: http://gilead.com/responsibility/us-patient-access/truvada%20for%20prep%20medication%20assistance%20program.

• Support Path for Sovaldi and Harvoni. Gilead Sciences website, accessed February 25, 2016. Available here: http://gilead.com/responsibility/us-patient-access/support%20path%20for%20sovaldi%20and%20harvoni.