Durability of first-line antiretroviral treatment in the Russian Federation: retrospective study

Objective. To assess durability of antiretroviral therapy in first line in HIV-infected patients in real clinical practice in the Russian Federation and determine association between basic clinical and demographic characteristics and durability of treatment.

Materials and methods. A non-interventional retrospective study was conducted collecting data from primary medical records of HIV-infected patients who signed informed consent form and had started antiretroviral therapy in first line. Patients were enrolled if the third component was a non-nucleoside reverse transcriptase inhibitor (NNRTI) or ritonavir boosted protease inhibitor (PI/r) plus two nucleoside reverse transcriptase inhibitors (NRTIs). Also, patients must have been followed up for at least 96 since start of treatment. Durability of therapy was retrospectively assessed at 48±8 and 96±8.

Results. 536 patients were enrolled. Percentage of patients without change of therapy was approximately 76% and 60%, and the mean duration of therapy without changes was approximately 47 and 79 weeks at 48±8 and 96±8 weeks,  correspondingly. Durability of treatment was not different for NNRTI+2NRTIs and PI/r+2NRTIs. Only age ≥ 40 years as a basic characteristic was associated with ART change prior to 96 weeks: OR=1.391, 95% CI 1.005-1.925.

Conclusions. In real clinical practice in Russia, durability of first-line antiretroviral therapy corresponds published scientific data (in terms of percentage of patients without change of treatment and its duration without change). Durability of treatment and factors associated with its early switch or stop should be investigated in prospective studies further.

1. Spravka «VICH-infekciya v Rossijskoj Federacii na 31 dekabrya 2021 g. http://www.hivrussia.info/wp-content/uploads/2022/03/Spravka-VICH-v-Rossii-na-31.12.2021-g.pdf

2. Michaels S.H., Clark R., Kissinger P. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. New England Journal of Medicine 1998 339:6 (405-406). https://doi.org/10.1056/NEJM199808063390612

3. De La Torre-Lima J. et al. Durability of the first antiretroviral treatment regimen and reasons for change in patients with HIV infection. HIV Clinical Trials 2014 15:1 (27-35) https://doi.org/10.1310/hct1501-27

4. Alema N.M. et al. Magnitude and predictors of first-line antiretroviral therapy regimen change among HIV infected adults: A retrospective cross-sectional study. Annals of Medicine and Surgery 81 (2022) 104303. https://doi.org/10.1016/j.amsu.2022.104303

5. Fahrni M.L. et al. Clinical predictors of efavirenz-based regimen treatment durability: A two-year case-control study of antiretroviral-naïve patients. Journal of Infection and Public Health 16 (2023) 96–103 https://doi.org/10.1016/j.jiph.2022.12.001

6. Chang H.-M. et al. Durability of single tablet regimen for patients with HIV infection in Southern Taiwan: data from a real-world setting. Chang et al. BMC Infectious Diseases (2022) 22:2. https://doi.org/10.1186/s12879-021-06919-6

7. Perez-Cordon L. et al. Durability of oral dual antiretroviral therapy in HIV patients. Eur J Hosp Pharm 2022;29(Suppl 1): A1–A218; 4CPS-164. https://doi.org/10.1136/ejhpharm-2022-eahp.400

8. Taramasso L. et al. Durability of Dolutegravir-Based Regimens: A 5-Year Prospective Observational Study. AIDS PATIENT CARE and STDs, Volume 35, Number 9, 2021; 342-353. https://doi.org/10.1089/apc.2021.0089

9. Lumu I., Musaazi J., Castelnuovo B. Durability of second-line anti-retroviral therapy in a к resource-limited setting: an 11-year analytical cohort. AIDS 2022, 36:1791–1800. http://dx.doi.org/10.1097/QAD.0000000000003340

10. Nacional’nye rekomendacii po dispansernomu nablyudeniyu i lecheniyu bol’nyh VICH-infekciej. Epidemiologiya i infekcionnye bolezni. Aktual’nye voprosy №6 (prilozhenie) / 2017.

11. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach – 2nd ed. World Health Organization 2016.

12. Sizova N. et al. Durability of first-line antiretroviral treatment in Russia: retrospective study. Journal of the International AIDS Society 2022, 25(S6): e26009. Abstract P100. https://doi.org/10.1002/jia2.26009