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Long-acting ART may be cost-effective for patients with poor adherence
Long-acting ART could be beneficial for patients with HIV, particularly those with poor adherence to daily medication, according to a model created by researchers at Massachusetts General Hospital.
Such treatment would be cost-effective as a second-line therapy or in patients with multiple treatment failures, they found, but the cost would have to decrease to the cost of current medications for it to be cost-effective as a first-line therapy. Long-acting (LA) ART formulations are currently in development and could potentially allow ART dosing via a 3-month injections if effective, the researchers wrote in Clinical Infectious Diseases.
“LA-ART produced appreciable survival gains in the overall population, but the benefits were greatest among those with low adherence,” the researchers wrote. “LA-ART could add almost 1 full year to the life expectancy of patients with poor adherence. While these patients represent less than 25% of the population receiving ART in the US, these substantial survival gains remain clinically meaningful even when averaged across all patients, the majority of whom are unlikely to benefit directly from LA-ART.”
The researchers constructed a mathematical model to evaluate the clinical impact and cost-effectiveness of LA-ART. They predicted quality-adjusted survival, cumulative health care costs and the maximum annual cost at which an LA-ART strategy would be cost-effective. They evaluated three different LA-ART strategies: LA-ART for patients with multiple virologic failures, LA-ART as a second-line therapy for patients who failed first-line therapy, and LA-ART as a first-line therapy.
Among the overall cohort, LA-ART increased the life expectancy from 23.72 years with daily ART only, to 23.87 years with LA-ART after multiple failures, 23.9 years with second-line LA-ART and 23.96 years with first-line LA-ART. Among patients with adherence in the lowest 20% of the cohort, LA-ART increased the life expectancy from 13.53 years with daily ART only, to 14.04 years with LA-ART after multiple failures, 14.17 years with second-line LA-ART and 14.42 years with first-line LA-ART.
LA-ART was cost-effective after multiple failures at a cost of $48,000 or less per patient-year. In a sensitivity analysis, the threshold ranged from $40,000 to $70,000.Second-line ART was cost-effective if the price reduced to $27,000 or less per patient-year, at which point it would be cost-saving for patients with multiple failures. The sensitivity analysis threshold ranged from $26,000 to $31,000. To be cost-effective as a first-line treatment, the cost would need to be no more than $24,000 per patient-year, at which point it would be cost-saving as a second-line treatment. The threshold in the sensitivity analysis was $24,000 to $27,000.
“The cost of future LA-ART regimens will play a substantial role in determining their role,” the researchers wrote. “At annual costs in the $40,000-$70,000 range, LA-ART will offer good value in patients with multiple prior ART failures. At an annual cost approaching that of currently available regimens, it will also be cost-effective as first-line or second-line therapy.”
Disclosure: The researchers report no relevant financial disclosures.
Perspective
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Long-acting antiretroviral agents have been in development for several years. Two examples are a long-acting version of cabotegravir, an investigational integrase inhibitor, and a long-acting version of rilpivirine, both of which are now in clinical trials with the intention that they would be given together as a long-activing drug regimen.
Long-activing therapy could offer advantages certain patient populations. We can now treat HIV with a single daily pill in many patients, and this will continue to be preferred for the majority. But there are settings in which long-acting ART would be attractive, such as prisons and methadone clinics. Long-acting ART is also a potential option for the treatment of nonadherent patients. However, patients who are nonadherent to treatment are often nonadherent with clinic visits as well. Missing a dose of a long-acting regimen would lead to prolonged subtherapeutic drug levels, increasing the risk of resistance.
Long-acting ART is also being studied for pre-exposure prophylaxis (PrEP). Ongoing trials are looking at injections of cabotegravir given every 3 months for prevention of HIV. This is an attractive concept. Patients who have no chronic medical conditions are not used to taking a daily pill for prevention, whereas infrequent injections, similar to injectable contraceptives, may be more acceptable to many PrEP candidates.
We’re enthusiastic about the development of long-activing antiretroviral agents and regimens, but we all recognize that it is not a panacea, and will be useful in selected patient populations.