Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV

• Published in: AIDS (London) Vol. 22; no. 2; pp. F1 - F9
• Main Authors: PULIDO, Federico, ARRIBAS, José R, RUBIO, Rafael, NORTON, Michael, DELGADO, Rafael, CABRERO, Esther, GONZALEZ-GARCIA, Juan, PEREZ-ELIAS, Maria J, ARRANZ, Alberto, PORTILLA, Joaquin, PASQUAU, Juan, IRIBARREN, José A
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 11.01.2008
• Subjects: Adult; Aged; AIDS/HIV; Anti-HIV Agents - administration & dosage; Anti-HIV Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiretroviral Therapy, Highly Active; Antiviral agents; Biological and medical sciences; Drug Administration Schedule; Female; HIV Infections - drug therapy; HIV Infections - virology; HIV Protease Inhibitors - therapeutic use; HIV-1 - classification; HIV-1 - genetics; HIV-1 - isolation & purification; Human immunodeficiency virus; Human viral diseases; Humans; Immunodeficiencies; Immunodeficiencies. Immunoglobulinopathies; Immunopathology; Infectious diseases; Lopinavir; Male; Medical sciences; Middle Aged; Nucleosides - adverse effects; Nucleosides - therapeutic use; Pharmacology. Drug treatments; Pyrimidinones - administration & dosage; Pyrimidinones - therapeutic use; Ritonavir - administration & dosage; Ritonavir - therapeutic use; RNA, Viral - genetics; Spain; Treatment Outcome; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Viral Load; Spain; Immunopathology; Antiretroviral agent; Enzyme; Ritonavir; Lopinavir; Enzyme inhibitor; Retroviridae; AIDS; Immune deficiency; Lentivirus; Infection; Virus; Peptidases; Viral disease; Maintenance treatment; Hydrolases; Antiviral; Nucleoside; Human immunodeficiency virus; Protease inhibitor; Comparative study
• ISSN: 0269-9370; 1473-5571
• DOI: 10.1097/QAD.0b013e3282f4243b

Prior attempts to reduce the number of drugs needed to maintain viral suppression in patients with suppressed HIV replication while receiving three antiretroviral drugs have been unsuccessful. In 205 patients with suppressed HIV replication on lopinavir-ritonavir and two nucleosides, this randomized, open-label, non-inferiority clinical trial compared the strategies of continuation of triple therapy versus lopinavir-ritonavir monotherapy followed by reinduction with two nucleosides if virological rebound occurred without genotypic resistance to lopinavir-ritonavir. The primary endpoint was proportion of patients without therapeutic failure, defined as confirmed HIV RNA higher than 500 copies/mL (with exclusion of patients receiving monotherapy who resuppressed to < 50 copies/mL after resuming baseline nucleosides), or loss to follow-up, or change of randomized therapy other than reinduction. At week 48, the percentage of patients without therapeutic failure was 94% in the monotherapy group versus 90% in the triple therapy group (difference,-4%; upper limit of 95% confidence interval for difference, 3.4%). The percentage of patients with HIV RNA 50 copies/mL at 48 weeks by intention-to-treat, missing data or reinductions considered as failures, were 85% in the monotherapy group versus 90% in the triple therapy group (P = 0.31; 95% upper limit of 95% confidence interval for difference, 14%). In this trial, 48 weeks of lopinavir-ritonavir monotherapy with reintroduction of nucleosides as needed was non-inferior to continuation of two nucleosides and lopinavir-ritonavir in patients with prior stable suppression. However, episodes of low level viremia were more common in patients receiving monotherapy.