Landmark HIV diagnostic access program will save $150m and help achieve new global goals on HIV

By increasing access to viral load testing, this new deal will dramatically improve the quality of HIV treatment services and strengthen capacity to achieve the global goal of ensuring that 90% of all people receiving antiretroviral therapy achieve viral suppression. The high price of viral load testing – is an important reason why less than one in four people on antiretroviral therapy currently have access to viral load testing.

Increasing the affordability and availability of viral load testing is pivotal to hopes to end the AIDS epidemic. With the aim of laying the foundation to end the AIDS epidemic by 2030, the world has embraced a new treatment target for 2020: 90% of all people living with HIV know their HIV status; 90% of all people with diagnosed HIV infection receive antiretroviral therapy; and 90% of all people receiving HIV treatment are virally suppressed. More than 13 million people currently receive HIV treatment.

“We welcome this significant price breakthrough—the urgent call of people living with HIV is being answered. Now, with viral load testing, we can help ensure HIV treatment improves quality of life,” said UNAIDS Executive Director Michel Sidibé. “I congratulate all partners for this timely agreement. It is an excellent example of public-private partnership in action and the kind of innovation needed to accelerate ending the AIDS epidemic.”

With viral load testing, doctors and nurses in developing countries can help ensure that their patients are on the right drug regimens and keep the amount of the HIV virus in their patients at ‘undetectable’ levels. This helps ensure that patients stay healthy while also preventing HIV transmission.
The UNAIDS sponsored Diagnostics Access Initiative, launched at the International AIDS Conference in Australia in July 2014, issued a call to the global community to achieve more affordable pricing for viral load testing. Through the leadership of South Africa and in partnership with CHAI, UNAIDS, The Global Fund and the US President’s Emergency Plan for AIDS Relief (PEPFAR), suppliers were challenged to lower viral load prices, and Roche is the first company to step forward and offer the HIV community an access policy that will accomplish these goals. Other partners in the DAI include the World Health Organization, US Centers for Disease Control and Prevention, African Society for Laboratory Medicine, UNITAID, the Global Fund, PEPFAR, Clinton Health Access Initiative and UNICEF.

“We applaud all the global partners who came together to ensure that over 31 million people living with HIV/AIDS in low and middle-income countries will be able to access viral load testing at this reduced price,” said President Bill Clinton, Chairman of the Clinton Health Access Initiative. “The Clinton Health Access Initiative has partnered with South Africa in its fight against HIV for more than a decade. We are honored to work with a government that is committed to HIV treatment not only in its own borders, but around the world.”

South Africa is the largest purchaser of viral load tests in the world, and the National Health Laboratory Service (NHLS) has the largest viral load program on the continent. The NHLS worked closely with Roche and other partners to create a framework that would benefit not only the 2.5 million people on treatment in South Africa, but millions more receiving antiretroviral therapy across sub-Saharan Africa and beyond.

“To end the AIDS epidemic in South Africa, we will need to build on this record of success to deliver the very highest quality of HIV treatment services, as measured by the proportion of people living with HIV who have viral suppression,” said President Jacob Zuma of South Africa. “Thanks to our ongoing partnership with the Clinton Health Access Initiative and UNAIDS, South Africa has been able to significantly reduce the per-patient price of this essential diagnostic test.”

The Global Access Program continues the longstanding leadership of Roche, which has played an important role in the AIDS response.

“As the leader in HIV viral load testing, Roche supports the UNAIDS 90-90-90 goal and the Diagnostics Access Initiative by expanding access to quality HIV testing through affordable pricing to those countries hardest hit by the disease,” stated Roland Diggelmann, Chief Operating Officer of Roche Diagnostics. “With 70% of all people living with HIV residing in Sub-Saharan Africa, we believe our commitment can truly make a difference to UNAIDS’ goal for achieving control of the HIV/AIDS epidemic.”

Leading AIDS donors welcomed the Program and pledged to effectively leverage it to scale-up viral load testing. “PEPFAR is committed to moving forward to increase use of viral load to monitor patient outcomes for PEPFAR-supported clients with the ultimate goal that all patients remain undetectable for their own health and for increasing control of the HIV pandemic,” said Ambassador Deborah L. Birx, M.D., the US Global AIDS Coordinator. “We are working on roll-out plans in partnership with countries to ensure that over the next four years all PEPFAR-supported patients and clinicians have access to accurate quality viral load data.” PEPFAR currently supports antiretroviral therapy for more than four million patients, excluding South Africa.

“The Global Fund welcomes this new initiative,” said Global Fund Executive Director Mark Dybul. “Due in large part to the high price of available technologies, many treatment programs have yet to prioritize scale-up of viral load testing. The Roche Access Program offers an important incentive to rapidly expand access to viral load testing.”

The Clinton Health Access Initiative was founded in 2002 (then the Clinton HIV/AIDS Initiative) to support government partners and address the HIV/AIDS crisis in developing countries. CHAI began work in South Africa in 2003, where they supported the government in their first national HIV treatment scale-up plan. Since then, CHAI has helped South Africa save $900M on ARV costs over 4 years; supported a testing initiative that reached 15 million people over 15 months; and assisted in the scale-up of HIV treatment to more than 4,000 health facilities around the country.

The Clinton Health Access Initiative’s role in helping to structure the new viral load agreement was made possible by the UK Department for International Development (DFID), one of CHAI’s closest and most long-standing partners. DFID funds pioneering market shaping work for essential health commodities such as medicines, vaccines, diagnostics and contraceptives. This helps organizations and governments to allocate and spend their funding more efficiently and enhances access for those most in need. They also work closely with the government of South Africa and support their efforts to aggressively scale-up HIV treatment and achieve greater efficiency in HIV spending.