Paper # 584 
Second-line LPV/r Monotherapy Was Inferior to TDF/3TC/LPV/r in Patients who Failed NNRTI Regimen: HIV STAR Study
Torsak Bunupuradah*1, P Chetchotisakd2, W Munsakul3, S Jirajariyavet4, P Kantipong5, W Prasithsirikul6, S Sungkanuparph7, C Bowonwatanuwong8, V Klinbuayaem9, K Ruxrungtham10, and HIV STAR Study Team
1HIVNAT Res Collaboration, Thai Red Cross AIDS Res Ctr, Bangkok; 2Faculty of Med, Khon Kaen Univ, Thailand; 3Bangkok Metropolitan Admin Med Coll and Vajira Hosp, Thailand; 4Taksin Hosp, Bangkok, Thailand; 5Chiangrai Prachanukroh Hosp, Thailand; 6Bamrasnaradura Inst, Nonthaburi, Thailand; 7Ramathibodi Hosp, Bangkok, Thailand; 8Chonburi Hosp, Thailand; 9Sanpatong Hosp, Chiang Mai, Thailand; and 10Faculty of Med, Chulalongkorn Univ, Bangkok, Thailand
Background: Antiretroviral monotherapy aims to reduce
side effects and cost. We report the first randomized study of
lopinavir/ritonavir monotherapy (mono-LPV/r) as second-line therapy in
HIV-infected adults failing NNRTI-based HAART.
Methods: We switched 200 Thais with HIV RNA ≥1000
copies/mL while using NNRTI + 2 NRTI, and naïve to protease inhibitors (PI), to
LPV/r 400/100 mg twice daily or tenofovir (TDF)/lamivudine (3TC) /LPV/r.
Protocol-defined treatment failure was HIV RNA >400 copies/mL at ≥24
weeks confirmed by a second measurement. TDF + 3TC were added in patients in
the monotherapy arm who met these criteria.
Results: Subjects were 58% male, with median (IQR)
age of 37.1 (32.7 to 41.7) years, CD4 count of 188 (106 to 284) cells/mm3,
and HIV- RNA of 4.1 (3.6 to 4.5) log10 copies/mL. At screening
visit, 92% used 3TC, 63% used stavudine, 23% used zidovudine, and 5% used TDF.
Nevirapine and efavirenz were used in 86% and 14%, respectively. Without
significant differences between study arms, 15% of subjects had ≥3 TAMS,
82% had M184V/I, 6% had Q151M, and 7% had K65R. By intent-to-treat analyses at
48 weeks, the proportion of patients with HIV RNA <400 copies/mL in the mono-LPV/r
arm was 83% vs 86% in the TDF/3TC/LPV/r arm (95% confidence
interval, 13.1 to 7.3; p = 0.58). However, only 64% of the mono-LPV/r
arm vs 82% in TDF/3TC/LPV/r arm had a viral load <50 copies/mL (p <0.01).
Major PI mutations were detected in 1 of 2 mono-LPV/r- and 0 of 3 TDF/3TC/LPV/r-treated
subjects who underwent genotyping following treatment failure. There was no
significant difference in CD4 count between arms. One death (unrelated to study
drugs) was reported in each arm. Serious adverse events were reported in 2
patients in mLPV/r arm and 7 patients in LPV/r-based HAART arm.
Conclusions: In patients who failed NNRTI regimens
and who were PI-naive, mono-LPV/r and TDF/3TC/LPV/r regimen produced similar
proportions of patients with HIV RNA < 400 copies/mL, but not for <50
copies/mL. Mono-LPV/r should be used with caution as a second-line option,
particularly in settings where close viral load monitoring is not available.
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