Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIV

Abstract

Two-drug regimens (2DRs) are emerging in clinical practice guidelines as treatment option for both naive and treatment-experienced people living with HIV (PLHIV). Objectives: To determine the real-life effectiveness of 2DR with 25 mg RPV plus 50 mg DTG in a single-tablet regimen (RPV/DTGSTR) and its impact on viral and immune status, lipid profile, and inflammatory markers. Methods: This observational study included 291 treatment-experienced PLHIV, starting 2DR with RPV/DTGSTR between 29 January 2019 and 2 February 2022, who were followed up for at least six months. Participants gave verbal informed consent for the switch in antiretroviral therapy (ART) to RPV/DTGSTR. Results: The mean age of the 291 participants was 51.3 years; 77.7% were male; and 42.9% were in the AIDS stage with a CD4 nadir of 283.5 ± 204.6 cells/uL. The median time since HIV diagnosis was 19.7 years (IQR: 10.6–27). Before 2DR, patients received a median of five ART lines (IQR: 3–7) for 22.2 years (IQR: 14–26), with 34.4% (n = 100) receiving a three-drug regimen (3DR), 31.3% (n = 91) receiving monotherapy, and 34.4% (n = 100) receiving 2DR. The median time on RPV/DTGSTR was 14 months (IQR: 9.5–21); 1.4% were lost to the follow-up. Effectiveness was 96.2% by intention-to-treat (ITT) analysis, 97.5% by modified ITT, and 99.3% by per-protocol analysis. Virological failure was observed in 0.69%, blips in 3.5%, and switch to another ART in 1.4%. The mean lipid profile improved, with reductions in TC/HDLc ratio (3.9 ± 0.9 vs. 3.6 ± 0.9; p = 0.0001), LDLc (118.3 ± 32.2 mg/dL vs. 106.2 ± 29.8 mg/dL, p = 0.0001), TG (130.9 ± 73.9 mg/dL vs. 115.9 ± 68.5 mg/dL, p = 0.0001), and CD4/CD8 ratio increase (0.99 ± 0.58 vs. 1.01 ± 0.54; p = 0.0001). The cost-effectiveness of 2DR with RPV/DTGSTR was similar to that of DTG/3TC and superior to those of BIC/TAF/FTC and DRV/c/TAF/FTC, with higher virological suppression and lower annual costs. Conclusions: The switch to RPV plus DTG in STR is a cost-effective, long-lasting, and robust strategy for PLHIV, with a very long experience of treatment, which improves the lipid profile without affecting inflammatory markers.

Efficacy and Safety of Two-Drug Regimens with Dolutegravir plus Rilpivirine or Lamivudine in HIV-1 Virologically Suppressed People Living with HIV

“…Although sub-optimal adherence cannot be excluded, it is reassuring that the future treatment options for those participants were not compromised. Furthermore, these findings correlate with clinical and real-world trials [6][7][8][23][24][25][26][27][28][29][30][31]33] and show that loss of virological control with DTG-based 2DRs is extremely rare and that the development of resistance to either DTG, 3TC, or RPV is rare. In this sense, our findings are attractive because we can demonstrate high rates of viral suppression despite including long-term diagnosed and pretreated PLWHIV and multimorbidity.…”

DOLAMA 200: Effectiveness and Safety of a Dual Therapy with Dolutegravir Plus Lamivudine in Treatment-Experienced HIV-1 Infected Real World Participants in Spain

“…The data obtained in this real-life study confirm that simplification to dual therapy with DTG + 3TC is an effective and safe as alternative to the standard triple therapy in pretreated and virologically stable HIV-infected patients, as shown in several clinical trials and other observational studies [ 14 , 15 , 16 ] along other dual therapies such as atazanavir/ritonavir plus lamivudine [ 5 ], dolutegravir plus boosted darunavir [ 22 ], rilpivirine plus boosted darunavir [ 23 ] or rilpivirne plus dolutegravir [ 19 , 24 ].…”

“…A pharmacoeconomic analysis was performed comparing DTG + 3TC therapy versus BIC/TAF/FTC, DRV/c/TAF/FTC and RPV/DTG as the most widely used reference treatments in the current HIV panorama. To perform this analysis, we retrieved data from studies with patients with similar characteristics using the results obtained from this study in mITT patients for DTG + 3TC treatment and those from the systematic review performed by Mazzitelli et al [ 17 ] for BIC/TAF/FTC, the EMERALD study for DRV/c/TAF/FTC [ 18 ] and the recent Rildo Study for RPV/DTG [ 19 ].…”

Special Issue “Efficacy and Safety of Antiviral Therapy”

“…Furthermore, they explore the effects of these treatments on lipid profiles, providing crucial insights into the potential metabolic implications for HIV patients. Hidalgo-Tenorio et al and Lee et al focused on the efficacy and safety of dual regimens—rilpivirine/dolutegravir and lamivudine/dolutegravir, respectively [ 12 , 13 ]. Hidalgo-Tenorio et al found a very low percentage of virological failure and excellent durability.…”