Trizivir (Abacavir/Lamivudine/Zidovudine) plus Lopinavir/Ritonavir Induction Therapy Followed by Trizivir-Alone Maintenance for HIV-1-Infected Patients: A 96-Week Pilot Treatment Simplification Study

Joseph C. Gathe, Dean T. Martin, M. Keith Rawlings, Benjamin Daquioag, John E. Fuchs, Vanessa C. Williams, Katrina L. Oie, Gary E. Pakes

Cigna Healthcare Corp., Phoenix, USA.
Glaxo-SmithKline, Research Triangle Park, Durham, USA.
Peabody Clinic, Dallas, USA.
Therapeutic Concepts P.A., Houston, USA.

DOI: 10.4236/wja.2012.23032                

Abstract

Objective: The purpose of this study was to investigate whether switching HIV-infected patients stabilized on Trizivir (abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg) plus lopinavir/ritonavir 400 mg/100mg twice daily to Trizivir alone affects clinical efficacy and tolerability. Methods: This phase 4, open-label, pilot study was conducted over 96 weeks in 23 antiretroviral-naïve, HIV-infected patients. Initially, these patients received induction therapy with Trizivir plus lopinavir/ritonavir 400 mg/100mg twice daily. Patients who achieved a viral load < 50 copies/mL at week 36 or 44 started maintenance therapy with Trizivir alone at week 48 and continued this regimen through week 96. Results: The study population was a median of 37 years of age, predominantly male (78%) and African American (61%, with 39% Caucasians), and had a baseline mean viral load of 5.45 log10 copies/mL and CD4+ count of 232 cells/mm³. Nineteen patients completed induction; of the four who did not, three were lost to follow-up and one withdrew due to gastrointestinal adverse events. In 14 induction completers who had viral load measurements taken at week 48, intent-to-treat: observed analysis showed a week 48 viral load < 400 copies/mL attained in 100% (14/14) and <50 copies/mL attained in 71% (10/14). Median week 48 CD4+ cell count was 192 cells/mm³ higher than the baseline count. Twelve patients completed the subsequent 48-week Trizivir-alone maintenance phase, of whom 11 (92%) achieved viral loads of both <400 and <50 copies/mL at week 96. Median week 96 CD4+ cell count was 208 cells/mm³ above baseline. Trizivir-only maintenance was associated with fewer adverse events than the Trizivir-lopinavir/ritonavir induction phase and with improvement in total cholesterol, LDL-cholesterol, and triglycerides. Conclusions: Trizivir-alone maintenance after Trizivir-lopinavir/ritonavir induction maintained virologic and CD4+ cell response, and was associated with an improved adverse event and lipid profile.

Keywords

Abacavir/Lamivudine/Zidovudine; HIV-1 Infection; Induction-Maintenance Strategy; Kaletra; Lopinavir/Ritonavir; Trizivir

Conflicts of Interest

The authors declare no conflicts of interest.

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