Week 120 efficacy of tenofovir, lamivudine and lopinavir/r-based second-line antiretroviral therapy in treatment-experienced HIV patients

Abstract

Background: Tenofovir (TDF) and ritonavir-boosted lopinavir (LPV/r) were not introduced to China as second-line medications until 2009. The efficacy and safety of TDF/3TC/LPV/r based second-line regimen have not been evaluated in Chinese HIV patients who failed first-line regimens.

Methods: This was a multicenter cohort study recruiting patients from Beijing, Shanghai, Guangdong, and Henan provinces between November 2008 and January 2010. Eighty HIV infected patients failing first-line regimens with serum creatinine lower than 1.5 times the upper limit of normal received TDF+ lamivudine (3TC)+ LPV/r were followed up for 120 weeks. CD4 cell count, viral load, and estimated glomerular filtration rate (eGFR) were monitored at each visit.

Results: At baseline, 31.2% and 48.8% of patients had moderate/high-level resistance to TDF and 3TC, respectively; while 2.5% of patients had only low-level resistance to LPV/r. During 120 weeks of follow-up, virological suppression rate reached over 70% (<40 copies/ml) and 90% (<400 copies/ml), and median CD4 cell count increased from 157 cells/μL at baseline to 307 cells/μL at week 120. Baseline drug-resistance mutations had no impact on the efficacy of second-line antiretroviral therapy. Median eGFR dropped from 104.7 ml/min/1.73m2 at baseline to 95.6 ml/min/1.73m2 at week 24 and then recovered after week 96.

Conclusion: This study for the first time demonstrated that TDF+ 3TC+ LPV/r was efficacious as second-line regimen with acceptable nephrotoxicity profiles in patients who failed zidovudine or stavudine based first-line regimens in China.

Trial registration: ClinicalTrials.gov NCT00872417.

Fig 1. Efficacy and eGFR changes during 120-week treatment (ITT analyses).

(A) Viral suppression rate (%) during 120-week follow-up. (B) CD4 cell count recovery during 120-week follow-up. (C) and (D) Estimated glomerular filtration rate (eGFR) during 120 weeks. Asterisks in (C) indicated significant differences compared with baseline levels. Asterisks in (D) indicated significant differences between groups with baseline eGFR over and lower than 90 ml/min/1.73m².