Amsterdam institute for Immunology and Infectious diseases

Two recent nationwide studies conducted in the Netherlands provide crucial insights into the real-world effectiveness of two new guideline-recommended HIV treatment options: long-acting injectable (LAI) cabotegravir plus rilpivirine, and the daily oral medication doravirine as part of a standard-of-care 3-drug regimen. While prior research has largely relied on clinical trials, these studies represent the first comprehensive real-world analyses of these therapies, offering valuable data on their effectiveness and tolerability.

Study 1: Long-Acting Injectables (LAI) – Cabotegravir and Rilpivirine

Led by Dr. Vita Jongen (Stichting hiv monitoring SHM, Public Health Services Amsterdam, and member of the Amsterdam institute for Immunology and Infectious diseases), the first study examined whether switching to LAI cabotegravir and rilpivirine provides a viable alternative to daily oral HIV treatments. Many people with HIV face adherence challenges due to stigma, daily pill burden, or forgetfulness, making an injectable option particularly appealing.

Switching to LAI cabotegravir and rilpivirine did not result in a higher risk of virological failure among individuals without prior HIV treatment failure. The real-world effectiveness aligns with clinical trial outcomes, confirming its potential as a switch option for individuals maintaining virological suppression with standard oral antiretroviral therapy (ART).

LAI treatments offer a promising alternative for individuals struggling with daily oral regimens, addressing issues related to stigma and pill fatigue. The findings reinforce the potential of LAI therapy in routine HIV care, expanding patient-centered treatment options.

Fig 1. Study 1. Estimated cumulative risk of loss of virological control among patients using LAI cabotegravir and rilpivirine and patients using a standard, oral, antiretroviral therapy. The table shows the number of patients still at risk of losing virological control at each time point—those who had not been censored or experienced loss of control earlier. Numbers in brackets indicate patients who lost virological control between two time points. Four cases occurring after two years of follow-up are not shown in the graph.

Study 2: Doravirine-Based Oral Treatment

The second study, led by Dr. Patrick Oomen (University Medical Center Utrecht) and Dr. Ferdinand Wit (Amsterdam UMC, Stichting HIV Monitoring, and member of the Amsterdam institute for Immunology and Infectious diseases), explored the effectiveness of doravirine-based daily oral ART. Doravirine is recognized for its favorable dosing schedule, flexibility of intake, absence of food restrictions, low drug-drug interaction potential, potent antiviral activity against HIV strains harboring common NNRTI-resistance associated mutations.

In a real-world settings, switching to doravirine-based treatment among virologically well-suppressed individuals with no history of virological failure was non-inferior in effectiveness and tolerability compared to continuing non-doravirine-containing regimens.

Doravirine provides a safe and effective switch option for individuals experiencing side effects, tolerability issues, or drug-drug interactions with other oral ART regimens. Its use can enhance treatment adherence and quality of life for people with HIV seeking a more convenient and flexible daily regimen.

Conclusion

These nationwide studies confirm the effectiveness of both long-acting injectable and doravirine-based oral HIV treatments in real-world settings. The findings support the expansion of treatment options for people with HIV, emphasizing the importance of personalized approaches to HIV management. LAI therapy offers a crucial alternative for those facing adherence challenges with daily oral pills, while doravirine provides a reliable option for individuals seeking improved tolerability and flexibility.

For more information contact Vita Jongen (v.w.jongen@amsterdamumc.nl) or Ferdinand Wit (f.w.wit@amsterdamumc.nl) or read the scientific publications below:

• Effectiveness of bi-monthly long-acting injectable cabotegravir and rilpivirine as maintenance treatment for HIV-1 in the Netherlands: results from the Dutch ATHENA national observational cohort.
• Real-world effectiveness and tolerability of switching to doravirine-based antiretroviral therapy in people with HIV: a nationwide, matched, prospective cohort study.

Text: Esmée Vesseur (AI&I) and Sacha Boucherie (SHM)

Amsterdam UMC researchers involved:

Study 1: Effectiveness of bi-monthly long-acting injectable cabotegravir and rilpivirine as maintenance treatment for HIV-1 in the Netherlands

Vita Jongen^1,2,3, PhD, Senior researcher

Ferdinand Wit^1,2, PhD, Senior researcher

Anders Boyd^1,2, PhD, Biostatistician and Postdoc resesarcher

Kim Sigaloff¹, PhD, Principle Investigator

Marc van der Valk^1,2, Professor of Internal Medicine

Study 2: Real-world effectiveness and tolerability of switching to doravirine-based antiretroviral therapy in people with HIV: a nationwide, matched, prospective cohort study

Ferdinand Wit^1,2, PhD, Senior researcher

Marc van der Valk^1,2, Professor of Internal Medicine

¹Amsterdam Institute for Immunology and Infectious diseases (AI&I), Amsterdam UMC, the Netherlands

²Stichting hiv monitoring, Amsterdam, the Netherlands

³Department of Infectious Diseases, Public Health Service Amsterdam (GGD), Amsterdam, The Netherlands

Funding

The ATHENA Cohort is managed by the Stichting hiv monitoring and is funded by the Dutch Ministry of Health, Welfare and Sport (VWS) through a grant from the Centre for Infectious Disease Control at the National Institute for Public Health and the Environment (RIVM).