Journal Article

Abacavir/Lamivudine plus Rilpivirine Is an Effective and Safe Strategy for HIV-1 Suppressed Patients: 48 Week Results of the SIMRIKI Retrospective Study

Knobel, Hernando, Boix, Vicente, Ryan, Pablo, Castaño, Manuel, Galindo, María José, Imaz, Arkaitz, Solís, Javier, Carrero, Ana, Raffo, Miguel, Berenguer, Juan, Troya, Jesús, Terrón, Jose Alberto, Hontañón, Victor, Esteban, Herminia, Moreno, Santiago, Suárez-Lozano, Ignacio, Podzamczer, Daniel, Yllescas, María, Barrufet, Pilar, Ribera, Esteban, González-García, Juan

2016

Overview

Based on data from clinical practice, we evaluated the effectiveness and safety of switching to abacavir/lamivudine plus rilpivirine (ABC/3TC+RPV) treatment in virologically suppressed HIV-1-infected patients. We performed a multicenter, non-controlled, retrospective study of HIV-1-infected patients who switched treatment to ABC/3TC+RPV. Patients had an HIV-RNA <50 copies/mL for at least 24 weeks prior to changing treatments. The primary objective was HIV-1 RNA <50 copies/mL at week 48. Effectiveness was analyzed by intention-to-treat (ITT), missing = failure and on-treatment (OT) analyses. The secondary objectives analyzed were adverse effects changes in renal, hepatic or lipid profiles, changes in CD4+ cell count and treatment discontinuations. Of the 205 patients included, 75.6% were men and the median age was 49. At baseline, before switching to ABC/3TC+RPV, median time since HIV diagnosis was 13.1 years, median time with undetectable HIV-1 RNA was 6.2 years and median time of previous antiretroviral regimen was 3.1 years (48.3% patients were taking efavirenz and ABC/3TC was the most frequent backbone coformulation in 69.7% of patients). The main reasons for switching were drug toxicity/poor tolerability (60.5%) and simplification (20%). At week 48, the primary objective was achieved by 187 out of 205 (91.2%) patients by ITT analysis, and 187 out of 192 (97.4%) patients by OT analysis. The CD4+ lymphocyte count and CD4+ percentage increased significantly from baseline to week 48 by a median of 48 cells/μL (-50 to 189) and 1.2% (-1.3% to 4.1%), respectively, P<0.001. Thirty-eight adverse events (AE) were detected in 32 patients. Of these, 25 had no clear association with treatment. Three patients interrupted therapy due to AE. We observed a decrease in all lipid parameters, P<0.001, and a slight improvement in the glomerular filtration rate, P<0.01. Therapy was considered to have failed in 18 patients owing to virological failure (5 [2.4%]), toxicity/poor tolerability (4 [2%]), clinical decision (3 [1.5%]), loss to follow-up (3 [1.5%]), death (1 [0.5%]), and no clinical data (2 [1%]). The results of this study confirms that ABC/3TC+RPV is an effective, safe, and cost-effective option for the treatment of patients with virologically stable HIV-1 infection.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Abacavir / Acquired immune deficiency syndrome / Adult / AIDS / Analysis / Anti-HIV Agents - adverse effects / Anti-HIV Agents - therapeutic use / Antiretroviral agents / Antiretroviral drugs / Biology and Life Sciences / CD4 antigen / CD4 Lymphocyte Count / Cell number / Clinical trials / Depression - etiology / Dideoxynucleosides - adverse effects / Dideoxynucleosides - therapeutic use / Drug Administration Schedule / Drug Combinations / Drug dosages / Drug therapy / Drug Therapy, Combination / Efavirenz / Ethics / Failure analysis / Female / Glomerular Filtration Rate / HIV / HIV Infections - drug therapy / HIV Infections - virology / HIV-1 - genetics / HIV-1 - isolation & purification / Hospitals / Human immunodeficiency virus / Humans / Infections / Kidney - metabolism / Kidneys / Lamivudine / Lamivudine - adverse effects / Lamivudine - therapeutic use / Lentivirus / Lipids / Lipids - blood / Liver - metabolism / Lymphocytes / Male / Medical diagnosis / Medicine and Health Sciences / Middle Aged / Motivation / Patients / Quality of life / Research and Analysis Methods / Retrospective Studies / Retroviridae / Ribonucleic acid / Rilpivirine - adverse effects / Rilpivirine - therapeutic use / RNA / RNA, Viral - blood / Studies / Substance abuse treatment / Switching / Therapy / Toxicity / Treatment Outcome