Macleods: 3HP latent TB treatment
3HP preventive therapy protects people with latent TB from developing active TB, with a shorter treatment duration and fewer pills than previous regimens.
From 2021 to 2023, we provided Macleods with a volume guarantee to secure the availability of 3HP, supporting the work of the IMPAACT4TB partnership.
The challenge
Public health
Tuberculosis (TB) is a leading cause of death from an infectious disease. Latent TB infection occurs when someone is infected with TB-causing bacteria but is asymptomatic and non-infectious. About a quarter of the world’s population are estimated to have latent TB and, over a lifetime, 5-10% will develop active TB. The chance of latent TB becoming active is much higher in people living with HIV and household contacts of TB patients, particularly children under five.
The 3HP regimen effectively treats and cures latent TB in most patients. But access to preventive treatment was behind targets for the period 2018-2022. Addressing latent TB is essential to reducing the incidence and mortality of TB globally.
Market situation
The previous standard-of-care for latent TB, called isoniazid preventive therapy (IPT), was developed over 60 years ago and has seen limited uptake and poor patient adherence due to the treatment duration of six months or more. In 2018, the World Health Organization (WHO) updated its global guidance for latent TB management to include 3HP as a treatment option for both adults and children.
Historically, demand for 3HP has been limited by high prices and supply constraints. Prior to Macleods’ entry into the 3HP market, there were no suppliers of fixed-dose combinations and only one supplier of a 3HP co-pack with very limited production capacity.
Impact
By the end of the agreement:
661k
additional people living with HIV completed treatment with 3HP
166k
hospitalisations due to treatment side effects averted
1.3m
approximate cases of latent TB in household contacts averted
The product
3HP is a fixed-dose combination therapy that combines two antibiotics – isoniazid and rifapentine – for the treatment of latent TB. It is a short-course regimen, taken once a week for three months.
Because of its shorter treatment duration and reduced pill burden, 3HP is as effective as IPT, with fewer side effects and better completion rates (90% on 3HP versus 50% on IPT).
The partnership
MedAccess provided a volume guarantee to Macleods.
Macleods will continue to produce and supply 3HP, scaling up capacity to meet increasing demand. Our guarantee enabled Macleods to initially lower its price for 3HP to $15 per patient course, before a further reduction in August 2022 to $14.25 per patient course.
The volume guarantee agreement complemented a broader set of interventions provided by the Clinton Health Access Initiative (CHAI) and Unitaid, as part of the IMPAACT4TB programme led by The Aurum Institute, to support the commercialisation and roll-out of 3HP.
The new ceiling price was available in 138 low- and middle-income countries.
Impact
By the end of the agreement:
52
countries had accessed 3HP under the terms of our agreement
32%
average price reduction
$29m
in procurement savings
The impact
Our guarantee helped secure Macleods’ commitment to make 3HP available at $14.25 per patient course, setting a low-cost price benchmark for new competitors entering the market.
Since this volume guarantee was announced, a new supplier entered the market at the same price as Macleods, driving greater competition, improving supply sustainability, and increasing product choice.
As of 2024, we estimate the partnership had contributed to:
- an estimated additional 661,000 people living with HIV completing treatment, improving health outcomes and tackling onward transmission
- 166,000 fewer people hospitalised due to adverse effects from the medication when compared to the current standard-of-care,
- an estimated $29 million in procurement savings, through an average price reduction of 32%.
How we calculated the impact of this agreement
Lives changed
Downstream patient outcomes were estimated based on the pooled risk analysis developed for the 2020 update of the WHO Latent Tuberculosis Infection Guidelines, and represent relative risk for people living with HIV when comparing 3HP to the current standard-of-care, isoniazid preventive therapy.
Money saved
Impact was estimated based on actual price reductions for 3HP over the course of the volume guarantee.