Randomized Controlled Trial of Once-Daily Tenofovir,Lamivudine, and Lopinavir/Ritonavir Versus Remaining on the Same Regimen in Virologically Suppressed HIV-Infected Patients on Their First PI-Containing HAART Regimen

Abstract

Purpose: To assess the effects of switching to once-daily (QD) lopinavir/ritonavir (LPV/r)-based combination therapy in HIV-infected patients who are virologically suppressed (HIV viral load <50 copies/mL) on their first protease inhibitor (PI)-containing regimen. Method: In this 48-week, prospective, open-label, randomized study, patients were either switched to once-daily LPV/r, tenofovir (TDF), and lamivudine (3TC) (QD arm) or remained on their existing regimen (control arm). The primary endpoint of the study was the proportion of patients maintaining virologic suppression following 48 weeks of treatment. Results: Fifty and 22 patients were randomized to the QD and control arms, respectively. At week 48, there was no significant difference in virological suppression between the QD and control arms using intent-to-treat (missing = failure) analysis (p = .44). There was no significant difference in discontinuation rates between the two arms (p = .66). Significantly more patients randomized to the QD arm reported gastrointestinal adverse events compared with the control arm (p = .009). There were no study drug-related serious adverse events. Conclusion: For patients who are already virologically suppressed on their first PI-containing regimen, switching to a QD regimen of TDF+3TC+LPV/r resulted in similar rates of virologic suppression when compared with staying on existing therapy.     

Changes in Hematological Parameters After Switching Treatment of HIV-Infected Patients from Zidovudine to Abacavir or Tenofovir DF

Abstract

OBJECTIVE: To evaluate the safety profile and efficacy of salvage regimens containing amprenavir (APV) 600 mg twice daily and ritonavir (RTV) 200 mg twice daily. DESIGN: Prospective, single-center study. METHOD: The patient database of the department of infectious diseases was screened for patients who had failed at least two successive three-drug combinations. These patients were proposed to take APV and RTV in association with two to four other drugs. They were followed monthly for 6 months. RESULTS: Seventeen patients were included. They had been previously treated for 70 ± 23 months. At baseline, viral load (VL) was 4.86 ± 0.98 log₁₀ copies/mL and CD4 187 ± 145 10⁶/L. On week 24, using intent-to-treat analysis, VL decreased to 2.95 ± 1.59 log₁₀ copies/mL and CD4 increased to 365 ± 210 10⁶/L. Nine patients (53%) had a VL < 2.3 log₁₀ copies/mL. The most common adverse events were grade 1 or 2 diarrhea and an increase of cholesterol and triglyceride levels. Mean APV trough concentration was 1727 ± 1749 ng/mL on week 24. CONCLUSION: These data show that the combination of low-dose RTV and reduced doses of APV is safe. This combination can be added to nonnucleoside analogs.     

Dual Therapy with Lopinavir/Ritonavir plus Lamivudine could be a Viable Alternative for Antiretroviral-Therapy-Naive Adults with HIV-1 Infection Regardless of HIV Viral Load or Subgenotype in Resource-Limited Settings: A Randomised,Open-Label and Non-Inferiority Study from China

Backgrounds: This randomised controlled, open-label, non-inferiority trial was conducted in antiretroviral-naïve HIV-1-infected patients to assess the efficacy and safety of 48-week dual therapy of LPV/r plus 3TC (DT group) compared with Chinese first-line triple-therapy regimen (TT group). Methods: 198 were randomised to DT (n = 100) or TT (n = 98). Results: Ninety-two DT patients (92%) and 88 TT patients (89.8%) achieved HIV-1 RNA <50 copies/ml at week 48 (P = 0.629). Moreover, the safety profile was similar between two groups, and no secondary HIV resistance was observed. Conclusion: The results suggest that dual therapy of LPV/r plus 3TC is non-inferior to the first-line triple-therapy regimen in China.