Unitaid publishes Technology and Market Landscape for Hepatitis C Medicines

Geneva – The World Health Organization (WHO) estimates that 71 million people worldwide are chronically infected with Hepatitis C virus (HCV). Of those, 2.3 million people are co-infected with the human immunodeficiency virus (HIV) and HCV. In 2015, around 400,000 people died of HCV-related liver disease, and the global HCV burden is increasing.

Unitaid’s Technology and Market Landscape for Hepatitis C Medicines reviews the current global market for direct-acting antivirals (DAAs), which have revolutionized treatment for HCV. Combinations of direct-acting antivirals are highly effective; they can cure HCV infection in 12 weeks, and have limited side-effects. Combinations that are effective against all genotypes of HCV have started to become available. These pan-genotypic combinations can contribute to simplifying diagnostics and treatment, and could enable treatment to be introduced in resource-limited settings.

The first part of Unitaid’s report, on technology, reviews the various medicines and combinations now available to treat HCV and looks forward to regimens currently in development.

The second part of the report surveys the market for direct-acting antivirals, which is relatively new in low- and middle-income countries. Ensuring a robust supply of HCV drugs can be a challenge, with various market forces affecting their procurement and uptake. Though the market for generic direct-acting antivirals has developed fast, it remains fragile.

The report also asks how best to prioritize high-risk groups for HCV screening, diagnosis and treatment.  Some “pathfinder” countries are reportedly considering this approach. Groups at high risk for HCV infection include, among others, people living with HIV, people who inject drugs, prisoners and children born to HCV-positive mothers.

Offering HCV screening in, for instance, clinics for antiretroviral therapy and harm reduction services may make it easier to find HCV-positive patients, and to reduce new infections, the report concludes.

Read the report:

Technology and Market Landscape for Hepatitis C Medicines (2017)

Previous reports:

All Unitaid’s Hepatitis C publications

Unitaid marks World Hepatitis Day

Unitaid joins the global health community today to mark World Hepatitis Day, an occasion for raising public awareness of the epidemic of curable liver viruses that cause 1.34 million deaths each year.

Unitaid is helping to defeat the epidemic by investing US$ 58 million in three grant projects (2015-2019) aimed at hepatitis C (HCV). The projects seek to develop new and simpler diagnostics, establish innovative models for screening and treatment in HIV/HCV co-infected populations, and devise cost-reduction strategies.

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Unitaid’s investments in HCV:

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Transition to new HIV treatment regimens is key to meeting scale-up goals

By Greg Perry, Executive Director of the Medicines Patent Pool, and Lelio Marmora, Executive Director of Unitaid. 

This week’s 9th International AIDS Society Conference on HIV Science takes place in Paris, the site of the co-discovery of the HIV-1 virus and an epicentre of global AIDS research. The programme offers the international community an opportunity to take stock of both progress and challenges in preventing, diagnosing and treating the virus.

We have reason to be optimistic. On Thursday, UNAIDS reported a record 19.5 million people are accessing antiretroviral therapy, and for the first time more than half of all people living with HIV are on treatment. At no other time in history has the science of care been so advanced for the potential benefit of so many. New antiretrovirals (ARVs) and formulations that can improve treatment adherence, viral suppression and quality of life could get the world closer to ending the epidemic. Ensuring their adequate delivery and uptake in low- and middle-income countries (LMICs), with 90 per cent of the global HIV burden, should be top of mind for the community at this July’s conference.

Unitaid, strongly backed by the government of France, is engaged in overcoming barriers to health product access in LMICs. The organisation launched the Medicines Patent Pool (MPP) to improve the HIV response by licensing World Health Organization (WHO)-recommended and newly-registered medicines, as well as encouraging the development of suitable combination-products for developing nations.

When we started the MPP a little more than a half decade ago, quality-assured generic versions of new ARVs took 5-10 years to reach treatment programmes in resource-limited settings at affordable prices after their approval in the US and Europe. Millions of people living with HIV could not access the best treatments, and were forced to rely on older drugs with high toxicity. Once-a-day fixed dose combinations were rare. New medicines, including those used when people developed resistance, were costly. Sub-optimal care was the norm in the LMICs.

Today, thanks to the work of the MPP and other initiatives, low-cost generics are becoming more widely available. The MPP has signed licences for 12 ARVs, including WHO-recommended medicines for first- and second-line treatment, and new HIV medicines such as dolutegravir (DTG) and tenofovir alafenamide (TAF). One of the drugs of choice for people living with HIV in high-income countries, DTG is recommended by the WHO as part of an alternative first-line regimen. It is easily administered as a small tablet taken once-daily and has low-side effects and a high barrier to resistance. TAF is highly effective at low doses.

With the government of Kenya and other global partners, Unitaid recently introduced the first generic version of DTG, initially provided to 27,000 patients in the country. The MPP is working with patent holder ViiV Healthcare and ten generic manufacturing partners to produce DTG as both a stand-alone and as a novel fixed dose combination. If all goes well, MPP’s generic partners will file multiple dossiers for DTG and combinations that include DTG in dozens of developing countries by year’s end. The organisation is now targeting pipeline alternatives and new delivery systems that can be licensed soon to speed their availability in developing countries.

At the IAS on Sunday, the WHO released new guidelines for transitioning to new ARVs. New, optimized treatment regimens and formulations may not only improve clinical response, but could also help to overcome challenges with resistance and treatment failure. With the rapid availability of generics, innovations such as DTG could also provide significant savings for national budgets and thus boost scale-up in high prevalence countries.

Although MPP licences contribute to accelerating the development and approval of generics, many challenges remain. The international community must focus on strengthening local regulatory authorities and fast-track market authorization so that new antiretrovirals become available in the LMICs more quickly. Supported by Unitaid, the WHO’s Prequalification Programme has a key role to play as a collaborative mechanism to accelerate regulatory approval. Continued studies on the use of DTG and other new formulations in key populations are crucial. Unitaid is funding clinical trials to gauge safety and efficacy of DTG in pregnant woman and people living with tuberculosis. The organisation is also supporting projects to facilitate the introduction of new treatment regimens.

We have come a long way since Francoise Barre-Sinoussi isolated a retrovirus that kills T-cells from the lymph system at Institut Pasteur three decades ago. From the approval of zidovudine (AZT) in 1987 and HAART in 1995 to today’s new innovations, we have the tools at our disposal to end AIDS in this generation. We must all redouble efforts to ensure their delivery to people most in need.

Number of countries adopting HIV Self-Testing policies rises sharply

Geneva – Unitaid and the World Health Organization (WHO) announced today the publication of the 2017 HIV Rapid Diagnostic Tests for Self-Testing Landscape report. Released during the 9th IAS Conference on HIV Science in Paris, the third edition of the landscape report provides an updated analysis of the latest technologies and market trends in HIV self-testing (HIVST) in low- and-middle income countries (LMICs).

In comparison to the previous edition, this year’s report identifies a growing number of HIVST products entering the market along with an increase in the number of countries adopting HIV self-testing. A total of 40 countries have incorporated HIVST in their national policies, following the WHO’s recommendation in 2016 that HIV self-testing be offered as a complementary approach to existing HIV testing approaches. An additional 48 countries are currently developing national HIV self-testing policies. This is more than double the number reported a year ago, when only 16 countries had policies supporting self-testing.

“WHO applauds countries taking up innovative approaches, including HIV self-testing, as additional ways to reach people who are currently not accessing testing services and are at higher risk of HIV infection, such as key populations, young people, and men in many settings,” says Dr Gottfried Hirnschall, WHO’s Director of HIV Department and Global Hepatitis Programme. “WHO will continue working with countries and partners to further support the rapid scale-up of HIV testing, including self-testing.”

To date, four HIV rapid diagnostic tests have been approved for use by a founding member of the Global Harmonization Task Force, while only one HIV self-test has obtained the approval of the WHO Expert Review Panel for Diagnostics. All of these products are now included in the list of eligible products approved for procurement using Global Fund and Unitaid funds. In addition, several other HIVST products are nationally registered in Brazil, China, Kenya, and Nigeria.

According to the report, pricing of HIV self-test kits continues to vary widely both across and within countries. In high income countries, prices range from US$ 22-48 in the private sector to US$ 7.50-15 per test kit in the public sector. While in emerging countries, prices vary from US$ 3-6 per test in the public sector to US$ 8-16 in the private sector. However, HIVST pricing in LMICs may begin to decrease, in part due to the Bill & Melinda Gates Foundation’s recent agreement to support the affordable sale of OraSure Technologies’ OraQuick® Self-Tests, in an effort to accelerate scale-up. As a result, public and non-profit buyers in 50 LMICs and high HIV burden countries will be able to purchase OraSure tests at the price of US$ 2 per kit.

At least four million HIV self-test kits are expected to be procured by donor-funded programmes between July 2017 and end of 2018, mainly the Unitaid-funded Self-Test Africa (STAR) Initiative, followed by programmes funded respectively by the Global Fund and the US President’s Emergency Plan for AIDS Relief (PEPFAR).

“Unitaid is at the forefront of global efforts to expand access to HIV self-testing in lower- and middle-income countries,” said Unitaid Executive Director Lelio Marmora. “The findings of this report show that our investments, and those of our partners, are helping countries to move forward in pursuit of the global goal of having 90 per cent of people living with HIV aware of their status by 2020.”

The STAR initiative and other efforts also provided the global community with a range of HIVST distribution models and systems to support linkage to care, promote products, and educate end users, all of which can inform HIVST programming in other regions.

“We’ve seen the effectiveness of HIV self-testing first hand through STAR,” states Dr. Karin Hatzold, Project Director STAR. “The successful scale-up of HIVST in initial STAR countries and its rapid introduction in new countries under the Initiative will provide a model for adoption in other regions.”

Despite these positive developments, successful implementation of HIV self-testing faces several challenges, including the level of government and donor support, uncertain and non-transparent regulatory pathways at the country-level, the need for product innovation, and low and unpredictable demand. Country governments, manufacturers, and partners, must continue to work together to address these challenges and support the development of an HIV self-test market. Doing so could expand HIV testing coverage and help countries meet key global targets, namely diagnosing 90 per cent of all people with HIV by 2020.

Read the full report: “Landscape for HIV rapid diagnostic tests for HIV self-testing – 3rd edition” – July 2016.

The report was prepared by Population Services International (PSI) and the World Health Organization (WHO) with funding from Unitaid and the Bill & Melinda Gates Foundation.

For more information, please contact:

Andrew Hurst, Unitaid, +41795616807, hursta@unitaid.who.org

Tunga Namjilsuren, WHO, +41 79 203 31 76, namjilsurent@who.int

Sandy Garçon, Population Services International (PSI), +1- 202.790.3162, sgarcon@psi.org

About Unitaid

Unitaid invests in new ways to prevent, diagnose and treat HIV/AIDS, hepatitis C, tuberculosis and malaria more quickly, affordably and effectively. It brings the power of new medical discoveries to the people who most need them. And it helps sets the stage for the large-scale introduction of new health products by collaborating with Governments and funding partners such as PEPFAR and the Global Fund. Learn more at www.unitaid.org.

About the World Health Organization

The World Health Organization (WHO) is the United Nations specialized agency for global health. WHO’s Department of HIV works to provide leading normative and technical guidance and support to the Member States to accelerate their responses to HIV towards achieving the universal coverage of prevention, treatment, care and support of services for every person in need.

About Population Services International

PSI is a leading global health organization working in HIV, reproductive health, child survival, non-communicable diseases and sanitation. Partnering with the public sector and harnessing the power of markets, PSI provides lifesaving products, services and communications that empower vulnerable populations to lead healthier lives. Learn more at www.psi.org.

Landscape for HIV rapid diagnostic tests for HIV self-testing – 3rd edition – July 2016

World’s largest HIV self-testing initiative expands in critical new phase

Paris – Three out of 10 people living with HIV do not know they are infected with the virus. The HIV Self-Testing Africa (STAR) Initiative, funded by Unitaid, has amassed compelling evidence that self-testing can reach more people than traditional diagnostics, enabling individuals to learn their HIV status when and where they chose, and seek the treatment they need.

This bold new approach to diagnostics can help meet the United Nation’s ambitious 90-90-90 treatment targets, which call for 90 per cent of people living with HIV to be diagnosed, 90 per cent of those diagnosed to be on treatment and 90 per cent of those on treatment to be virally suppressed by 2020.

Today at the 9th IAS Conference on HIV Science (IAS 2017), the STAR consortium announced the expansion of the HIV Self-Testing Africa project to South Africa, Lesotho and Swaziland, making it the largest effort to date to create a thriving market for HIV self-testing in Africa.

Poor testing coverage among men, young people and other vulnerable populations in sub-Saharan Africa remains a challenge facing the HIV response. HIV self-testing (HIVST), which allows individuals to test themselves in complete privacy, has proven a critical tool to increase the adoption of HIV prevention and treatment services.

The first phase of the STAR project (2015-2017) established that HIVST can be used accurately by almost anyone; is widely accepted when offered through community- and health facility-based distribution models; and can satisfy demand among vulnerable and key populations that do not otherwise use conventional testing services.

“Preliminary results from STAR indicate that self-tests are helping to close knowledge-of-status gaps for groups that have traditionally been hard to reach with other HIV testing services, particularly young people and men,” said STAR Initiative Director Karin Hatzold. “More than a quarter of these populations using self-test kits have never tested before.”

OraQuick HIV self-test kits, manufactured by OraSure Technologies, were used for the first phase of the STAR project. The test allows an individual, using an oral swab, to get a result in as little as 20 minutes. OraQuick is the first HIV rapid diagnostic test prequalified by WHO, a status that indicates it complies with international standards. In addition, the Bill and Melinda Gates Foundation recently announced an agreement to support the affordable sale of OraQuick tests in 50 countries in Africa and Asia.

HIVST volumes generated by the Initiative will improve the health of the global market. HIVST demand will be increasingly predictable, lowering prices and encouraging introduction and scale-up of all available oral- and blood-based tests. This will advance efforts to build a sustainable supply of multiple, quality-assured and affordable HIV self-test products.

Across the three initial STAR countries – Malawi, Zambia and Zimbabwe – 60 to 90 per cent of individuals offered HIVST in rural communities took up the test. Those testing HIV-positive were referred successfully to care and treatment services. In Zimbabwe, 80 per cent of HIV-positive male self-testers reported that they had been referred to care services after self-testing. HIVST also increased the likelihood for HIV-negative men to take up prevention services such as voluntary medical male circumcision (VMMC).

“Thanks to the emerging evidence from STAR and research conducted in other countries, WHO released updated guidelines on HIV self-testing and partner notification in December 2016,” said WHO Technical Officer Cheryl Johnson. “The guidelines strongly recommend that HIVST should be offered as an additional approach to conventional HIV testing services.”

The second phase of the five-year STAR Initiative will build on this success, and aim to demonstrate increased efficiency and potential cost savings of HIVST. About 4.8 million HIV self-test kits will be distributed by 2020. Scaling up HIVST to meet growing demand will increase testing coverage among men, young people and vulnerable groups not currently accessing testing services. As a result, the initiative will directly feed into reaching the UN’s 2020 treatment target. The successful scale-up of HIVST in initial STAR countries and its rapid introduction in new countries under the Initiative will provide a model for adoption in other regions.

“If we are to achieve the first AIDS-free generation, more countries need access to this simple technology, including effective strategies for bringing it to scale,” said PSI President and CEO Karl Hofmann. “Innovative solutions like HIV self-testing helps bring care closer to the people who need it most. When we give consumers simple and cost-effective tools that allow them to take control of their own health we see better outcomes.”

“There is an urgent need to accelerate access to HIV self-testing and increase diagnosis among first-time testers who would not otherwise access testing services,” said Unitaid Executive Director Lelio Marmora. “By overcoming HIVST market constraints and increasing the number of people who know their HIV status, STAR has the potential to turn the course of the epidemic.”

The new five-year STAR project is being implemented by Population Services International (PSI) and Society for Family Health (SFH) South Africa, in collaboration with the World Health Organization (WHO), and consortium partners London School of Hygiene & Tropical Medicine and Wits Reproductive Health & HIV Institute.

CONTACT

For all press inquiries, please contact

Andrew Hurst, Unitaid, +41795616807, hursta@unitaid.who.int

Sandy Garçon, Population Services International (PSI), +1 (202) 469-6680, sgarcon@psi.org

ABOUT THE STAR CONSORTIUM

PSI and SFH South Africa head the STAR Initiative, in collaboration with the World Health Organization and MOHs in the six STAR countries. Research activities are led by the London School of Hygiene and Tropical Medicine and their partners Liverpool School of Tropical Medicine, and University College London. PSI leads the consortium Malawi, Zambia, Zimbabwe, Lesotho and Swaziland; in-country research activities are implemented by local research institutions: Malawi-Liverpool-Wellcome Trust Clinical Research Programme, ZAMBART, the Centre for Sexual Health and HIV/AIDS Research Zimbabwe and Africa Health Research Institute. SFH will lead implementation in South Africa with consortium partner University of Witwatersrand-Reproductive Health and HIV Institute. Learn more at www.psiimpact.com/star-hiv-self-testing-africa and www.hivstar.lshtm.ac.uk.

ABOUT UNITAID

Unitaid invests in new ways to prevent, diagnose and treat HIV/AIDS, hepatitis C, tuberculosis and malaria more quickly, affordably and effectively. It brings the power of new medical discoveries to the people who most need them. And it helps sets the stage for the large-scale introduction of new health products by collaborating with Governments and funding partners such as PEPFAR and the Global Fund. Learn more at www.unitaid.org.

ABOUT POPULATION SERVICES INTERNATIONAL (PSI)

PSI is a leading global health organization working in HIV, reproductive health, child survival, non-communicable diseases and sanitation. Partnering with the public sector and harnessing the power of markets, PSI provides lifesaving products, services and communications that empower vulnerable populations to lead healthier lives. Learn more at www.psi.org.

Unitaid welcomes data showing big rise in people on HIV treatment

Geneva – Unitaid welcomes the announcement by UNAIDS that for the first time, more than half of all people living with HIV have access to lifesaving treatment, and that AIDS-related deaths have almost halved since 2005.

UNAIDS said the new figures reflect a “tipping point” in the fight against the epidemic and noted that with a sustained scale-up in effort, the global health community is on track to reach the target of having 30 million people on treatment by 2020.

The Global Fund has published new results this week showing an increase of nearly one-fifth in the number of people receiving antiretroviral therapy through Global Fund-supported programmes.

“The results published by UNAIDS are highly positive, showing that 19.5 million of the 36.7 million people living with HIV now have access to treatment,” said Unitaid Executive Director Lelio Marmora. “However, the pace of innovation has to accelerate if we are to meet ambitious global goals and close the gap.”

Success brings new challenges. For example, with fewer children becoming infected, innovative strategies are needed to find and treat the ones who are being left behind.

To that end, Unitaid is funding $149.3 million in projects to bring state-of-the-art point-of-care diagnostics to promptly learn the HIV status of infants in Cameroon, Democratic Republic of Congo, Ethiopia, Kenya, Malawi, Mozambique, Senegal, Tanzania, Uganda and Zimbabwe.

For adults and adolescents, the HIV Self-Testing Africa (STAR) initiative, funded by Unitaid, is expanding into the largest effort to date to create a thriving market for HIV self-testing in Africa. The initiative has produced evidence that more people learn their HIV status when they can test themselves in private.

In addition, there is a growing need for more robust, simpler treatment regimes to allow HIV treatment to be maintained over a lifetime.

With that goal in mind, Unitaid and the Government of Kenya in June announced the introduction of dolutegravir, a less-toxic, easy-to-take drug for people living with HIV, making Kenya the first African country to introduce the generic version of this new drug for routine use.

HIV self-testing kits assessed for eligibility for procurement by the Expert Review Panel

Unitaid and Global Fund have concluded round 6 of the World Health Organization Expert Review Panel for Diagnostics, reviewing rapid diagnostic tests for HIV self-testing. See our original invitation to manufacturers more information:

  • Invitation to Manufacturers to Submit an Expression of Interest for Product Evaluation by the Global Fund Expert Review Panel for Rapid Diagnostics Products: Rapid Diagnostic Tests for HIV Self-testing
    download in English

Several blood-based HIV self-testing kits have been identified that may be considered for procurement, upon request by countries, and under a specific process determined by the Global Fund and Unitaid respectively. The conclusion of the quality risk assessment review is that the product has been categorized by the Expert Review Panel for Diagnostics as category 3, meaning that procurement with Global Fund and/or Unitad resources of this product will be permitted in exceptional circumstances. Because of the exceptional nature of this categorization, the referenced product will not be included in the procurement list dedicated to this type of products, published by the Global Fund on its website.

One oral fluid HIV self-testing kit has also been identified as eligible for procurement as a result of the Expert Review Panel for Diagnostics round 4 in February 2017 and is now reflected in the Global Fund list of eligible products for procurement with grant funds:

  • List of HIV Diagnostic Test Kits and Equipments Classified according to the Global Fund Quality Assurance Policy
    download in English

All information related to the procurement with Global Fund grants of products reviewed by the WHO Expert Review Panel, including instructions for Global Fund recipients, is available on our Diagnostic Products page.

Any grantee should seek authorization from Unitaid, when using Unitaid grants, before engaging in procurement of a product reviewed by the WHO Expert Review Panel.