ARV Market Report: The state of antiretroviral drug market in low- and middle-income countries, 2016-2021

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The HIV/AIDS community received good news ahead of the 2017 International AIDS Society (IAS) meeting in Paris: for the first time ever, more than 50 percent of people living with HIV were receiving antiretroviral therapy (ART) at the end of 2016 and AIDS-related deaths have halved since 2005. If this trend continues, the world will be on track to meet the UNAIDS Fast-Track targets of 30 million people receiving ART by 2020 –an ambitious, but now attainable, goal.

Two years after the World Health Organization (WHO) recommended that all people living with HIV be treated with antiretrovirals (ARVs), regardless of their clinical or immunological status, over 100 nations have incorporated “Test and Treat” policies into their national treatment guidelines – a key step in meeting the Fast-Track goals.

As the number of patients on ART continues to increase, ensuring that patients are on optimal regimens and formulations will be important to improve adherence and meet the “Third 90” goal of 90 patients of patients on treatment being virally suppressed. Dolutegravir (DTG), the standard-of-care drug in many developed nations, is poised to transform the ARV market in low- and middle-income countries (LMICs) in the coming years due to its improved clinical profile and lower costs when compared to current drugs. As of July 2017, over 20 LMICs had initiated procurement of generic DTG singles. In addition, two generic fixed-dose combinations of TDF/3TC/DTG (TLD) were approved by the United States Food and Drug Administration (FDA) in August 2017, with the first orders expected to arrive in countries in Q1 2018. While regulatory approval of TLD represents a significant milestone in the fight to ensure access to the best treatment for all people living with HIV, the announcement at the 2017 United Nations General Assembly of a ceiling price agreement negotiated with manufacturers by the Bill & Melinda Gates Foundation and CHAI ensures that TLD will be available in LMICs at an affordable price.

The pediatric market has seen a flurry of activity around bringing optimal ARVs, such as additional heat-stable LPV/r formulations and fixed-dose combinations of WHO-recommended regimens, to the market. Collaborations between partner organizations, such as the Global Accelerator for Pediatric Formulations (GAP-f), focus on upstream product prioritization and development as well as downstream product introduction and roll-out. Careful consideration will need to be given to long-term sustainability of the pediatric ARV market in light of decreasing need, as prevention of mother-to-child transmission (PMTCT) efforts continue to succeed in reducing new pediatric infections.

Beyond treatment, scaling up prevention efforts is critical to further decreasing the rate of new HIV infections and reaching the Fast-Track goal of 500,000 annual new infections by 2020 (compared to 1.8 million in 2016). Products such as oral pre-exposure prophylaxis (PrEP) continue to generate interest with over 10 LMICs incorporating oral PrEP into their national treatment guidelines as of this report’s publication. South Africa became the first LMIC to roll out oral PrEP into their national program in mid-2016, with over 2,300 individuals having been initiated on oral PrEP as of July 2017.

Whereas tremendous progress has been made in reducing the spread of HIV, it has not been equitable. The typical HIV “hot spots” in Eastern and Southern Africa have seen great progress in reducing the rates of new infections, but regions that have received relatively less international attention, such as Central Asia and Eastern Europe, have seen new infections increase by an alarming 60 percent. Additionally, key populations such as adolescent girls and young women, female sex workers, people who inject drugs, and men who have sex with men are still seeing disproportionally high rates of HIV infections.

Much work remains to end the AIDS epidemic as a public health threat. CHAI is focused on meeting this goal by working with Ministries of Health, suppliers and partners to ensure that all patients have access to the best drugs at affordable and sustainable prices, no matter where they live.