Similar Safety and Efficacy of Once- and Twice-Daily Lopinavir/Ritonavir Tablets in Treatment-Experienced HIV-1–Infected Subjects at 48 Weeks

• DOI: 10.1097/qai.0b013e3181cbd21e
• Publication Date: 2010-03-18T09:34:33Z
• Authors: Roberto Zajdenverg; Thomas J Podsadecki; Sharlaa Badal-Faesen; Jaime Andrade-Vil...; Joseph Gathe; Horacio Mingrone; Linda M Fredrick; Isabelle A Gaultier; W Chris Woodward; Barry M Bernstein
• Keywords: Adult; Male; Ritonavir; Anti-HIV Agents; HIV Infections; Nausea; HIV Protease Inhibitors; Pyrimidinones; Middle Aged; Viral Load; Lopinavir; CD4 Lymphocyte Count; Medication Adherence; 3. Good health; Young Adult; 03 medical and health sciences; 0302 clinical medicine; Antiretroviral Therapy, Highly Active; Drug Resistance, Viral; HIV-1; Humans; Female; Aged

To compare the safety and antiviral activity of once (QD) or twice (BID) daily lopinavir/ritonavir (LPV/r) in combination with investigator-selected nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in treatment-experienced subjects.Subjects failing treatment with HIV-1 RNA > 1000 copies per milliliter received LPV/r tablets 800/200 mg QD (n = 300) or 400/100 mg BID (n = 299) with investigator-chosen nucleoside/nucleotide reverse transcriptase inhibitors. Efficacy was determined by the intent-to-treat time to loss of virologic response (ITT-TLOVR) algorithm. Safety, tolerability, adherence, impact of baseline protease mutations on virologic response, and emergence of resistance on therapy were assessed.Demographics were comparable across groups. By intent-to-treat time to loss of virologic response, 166 QD subjects (55.3%) and 155 BID subjects (51.8%) were responders at week 48 (P = 0.413), with similar mean increases in CD4 T-cell count. QD subjects demonstrated better adherence than BID subjects. The occurrence of treatment-related moderate/severe adverse events was comparable for all events except nausea, which was reported more frequently among BID-treated subjects. Emergence of new protease resistance mutations on treatment was similarly infrequent in both groups.LPV/r dosed QD resulted in increased treatment adherence and was as efficacious as BID LPV/r while providing similar safety, tolerability, and limited resistance evolution.