Getting to 95-95-95: global use of HIV generics would result in large reductions in spending, new infections and deaths

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Generic HIV combination medications, 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 result each year in $26 billion being saved, 630,000 fewer new HIV infections and 240,000 fewer deaths, according to a recent study by Dr Katherine Heath and colleagues published ahead of print in AIDS.

The updated UNAIDS targets for 2025 aim for 95% of those living with HIV to know their status, 95% of those who know their status to be on treatment and 95% of those on treatment to be virally suppressed. While the previous 90-90-90 targets for 2020 were met by some countries, they were not met globally. The goals of fewer than 500,000 annual new infections and 500,000 AIDS-related deaths was also not in sight in 2019, with an estimated 1.7 million new infections and 600,000 AIDS-related deaths.

Access to affordable antiretroviral treatment (ART) is crucial to preventing onward transmission and AIDS-related deaths. However, the cost of treatment remains a barrier in many countries, especially where drug patents are enforced. While UNAIDS has been urging for increases in funding to meet targets, the opposite has been happening – funding for the global HIV response fell by 7% between 2017 and 2019, with low- and middle-income countries seeing reductions or flat funding from international donors.

Glossary

generic

In relation to medicines, 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 branded drugs, and have comparable strength, safety, efficacy and quality.

middle income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. There are around 50 lower-middle income countries (mostly 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 an infection from mother-to-baby, during pregnancy, childbirth, or breastfeeding.

 

low income countries

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

equivalence trial

A clinical trial which aims to demonstrate that a new treatment is no better or 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 advantages. 

The cost of HIV treatment varies greatly from country to country – in the US, the minimum cost of ART per person per year was $36,080 in 2018 compared to a country such as Georgia, where the cost of dolutegravir (DTG) was $27 and efavirenz (EFV) $39 per person per year. Widespread access to generic medications in low- and middle-income countries helps with lowering the 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 the 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 profit margin of 10% 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, with abacavir/lamivudine/dolutegravir (ABC/3TC/DTG) costing $75 and more expensive formulations, such as efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF) estimated to be $101. In contrast, ABC/3TC/DTG sold for $38,628 per person per year in the US in 2020.

Based on these estimates, it would cost $2 billion annually to reach the 95-95-95 targets in all 164 countries in the analysis, using TDF/3TC/DTG. In contrast, $28 billion was spent on HIV medication in 2019 globally. Even the more expensive generics, such as EFV/FTC/TDF, would be a fraction of this price at around $3.4 billion annually to reach the targets in all 164 countries.

As a comparison, global expenditure on just one patented combination drug, Biktarvy (TAF/FTC/BIC, Gilead), amounted to $4.7 billion in 2019 alone.

Reductions in 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 countries with low to medium prevalence, with medium prevalence countries having the highest number of new infections and deaths. This is partly because more resources have been dedicated to HIV in high prevalence countries, with more concerted efforts at increasing public awareness of HIV, and a focus on getting tested and starting immediate treatment.

If the 95-95-95 targets were reached in the 164 countries analysed, 631,398 new HIV infections, 66,308 instances of vertical transmission and 241,811 AIDS-related deaths could be prevented every year.

Conclusion

“The annual cost of 95-95-95 treatment coverage for the 164 countries in this study is equivalent to only four weeks of global sales at current prices,” the authors conclude. “Significant savings could be made by switching to quality-assured generics. Generic drug access is paramount to reduce HIV infections and deaths and ART must be made accessible at cost price to all who need it.”