Reach 95-95-95: Global use of HIV generics would lead to sharp cuts in spending, new infections and deaths

Generic combination HIV drugs, such as tenofovir / lamivudine / dolutegravir (TDF / 3TC / DTG), could be produced for as little as $ 59 per person per year. Achieving the 95-95-95 targets based on this cost could save $ 26 billion each year, 630,000 fewer new HIV infections and 240,000 fewer deaths, according to a recent study by Dr Katherine Heath and of his colleagues published before printing in AIDS.

Updated UNAIDS targets for 2025 aim to ensure that 95% of people living with HIV know their status, 95% of those who know their status are on treatment, and 95% of those on treatment are virally suppressed . While the previous 90-90-90 targets for 2020 were met by some countries, they were not met globally. The targets of less than 500,000 new infections annually and 500,000 AIDS-related deaths were also not in sight in 2019, with around 1.7 million new infections and 600,000 AIDS-related deaths.

Access to affordable antiretroviral therapy (ART) is essential to prevent transmission and AIDS-related deaths. However, the cost of treatment remains a barrier in many countries, especially when drug patents are enforced. While UNAIDS urged increased funding to meet the targets, the opposite has happened: funding for the global HIV response fell 7% between 2017 and 2019, income countries low or intermediate seeing cuts or stable funding from international donors.

Glossary

generic

With respect to drugs, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as brand name drugs and have comparable strength, safety, efficacy, and quality.

middle income countries

The World Bank ranks countries according to their income: low, lower-middle, upper-middle, and high. There are around 50 lower-middle-income countries (mainly in Africa and Asia) and around 60 upper-middle-income countries (in Africa, Eastern Europe, Asia, Latin America and the Caribbean).

vertical transmission

Transmission of infection from mother to baby, during pregnancy, childbirth or breastfeeding.

low income countries

The World Bank ranks countries according to their income: low, lower-middle, upper-middle, and high. While the majority of the roughly 30 countries classified as low income are in sub-Saharan Africa, many African countries, including Kenya, Nigeria, South Africa and Zambia, are in the middle income bracket.

equivalence test

A clinical trial that aims to demonstrate that a new treatment is neither better nor worse than an existing treatment. While the two drugs may have similar results in terms of virological response, the new drug may have fewer side effects, be cheaper, or have other benefits.

The cost of HIV treatment varies widely from country to country – in the United States, the minimum cost of ART per person per year was $ 36,080 in 2018 compared to a country like Georgia, where the cost of dolutegravir (DTG) was $ 27 and efavirenz (EFV) $ 39 per person per year. Widespread access to generic drugs in low- and middle-income countries helps lower costs, compared to middle- and high-income countries, where ART tends to be much more expensive.

The researchers aimed to estimate the lowest possible cost to meet the 95-95-95 targets, as well as subsequent reductions in new infections and deaths in 164 countries. This analysis was based on 2019 and 2020 data on HIV prevalence, new infections, vertical transmission and AIDS-related deaths in these countries and the cost of generic drugs. These estimates were based on the current cost of generic exports from India, including the cost of the active pharmaceutical ingredient, a 10% profit margin and tax.

Substantial cost reduction with generics

Combinations such as TDF / 3TC / DTG (recommended by the World Health Organization for first-line treatment) could be produced for as little as $ 59 per person per year, abacavir / lamivudine / dolutegravir (ABC / 3TC / DTG) costing $ 75 and more expensive formulations, such as efavirenz / emtricitabine / tenofovir (EFV / FTC / TDF) estimated at $ 101. In contrast, ABC / 3TC / DTG sold for $ 38,628 per person per year in the United States in 2020.

Based on these estimates, it would cost $ 2 billion per year to meet the 95-95-95 targets in the 164 countries in the analysis, using TDF / 3TC / DTG. In contrast, $ 28 billion was spent on HIV drugs in 2019 globally. Even the most expensive generics, such as EFV / FTC / TDF, would account for a fraction of that price at around $ 3.4 billion per year to meet targets in 164 countries.

For comparison, global spending for a single patented combination drug, Biktarvy (TAF / FTC / BIC, Gilead), was $ 4.7 billion in 2019 alone.

Reduction of new infections and deaths

Currently, countries with high HIV prevalence (such as South Africa and Eswatini) have higher ART coverage rates than those with low to medium prevalence. Thus, the number of new infections and deaths is higher in low to medium prevalence countries, with medium prevalence countries having the highest number of new infections and deaths. This is in part because more resources have been directed to HIV in high prevalence countries, with more concerted efforts to increase public awareness of HIV, and a focus on testing and starting HIV. immediate treatment.

If the 95-95-95 targets were met in the 164 countries analyzed, 631,398 new HIV infections, 66,308 cases of vertical transmission and 241,811 AIDS-related deaths could be prevented each year.

Conclusion

“The annual cost of 95-95-95 treatment coverage for the 164 countries in this study equates to just four weeks of global sales at current prices,” the authors conclude. “Significant savings could be made by switching to quality-assured generics. Access to generic drugs is key to reducing HIV infections and deaths, and ART must be made available at cost to all who need it.


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