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Table 2 Results of treatment outcomes with EFV-based regimens in eligible HIV-1-infected patients (n = 559)

From: Virological failure of staggered and simultaneous treatment interruption in HIV patients who began Efavirenz-based regimens after allergic reactions to nevirapine

   EFV-based regimens  
  Available data (n) Simultaneous Interruptiona Staggered Interruptionb Controlsc p valued
Total number, n 559 161 82 316  
Median duration of EFV-based regimens, months (IQR) 559 57 (27–73) 31 (18–52) 40 (23–65) <0.001
Once-daily regimen at end of study, % 378 66.0 53.7 69.2 0.097
Documented EFV-based regimen interruption, % e 559 9.3 3.7 2.8 0.007
Frequency of plasma HIV-RNA assays 559     
> 2 times/year, %   14.9 32.9 22.2 0.030
1–2 times/year, %   57.1 48.8 60.4  
< 1 time/year, %   28.0 18.3 17.4  
Primary outcome      
Incidence of virological failure, cases per 1,000 person-years 559 12.9 5.4 6.6  
Relative risk of having virological failure when compared to Control group, (95% CI) 559 1.97 (0.62–6.38) 0.83 (0.02–6.43)   
Secondary outcomes      
Virological suppressiong at 24 (±3) months, % (Per-protocol-analysis) 440 66.9 76.9 68.9 0.411
Median CD4 cell counts at 24 (±3) months, cells/μL (IQR) 327 352 (258–524) 387 (309–458) 340 (237–473) 0.483
Median increase from baseline in CD4 cell counts at 24 (±3) months, cells/μL (IQR) 317 264 (184–374) 292 (220–384) 273 (178–383) 0.647
Major opportunistic infections, % 556 6.83 4.88 5.75 0.812
Paradoxical immune recovery syndrome, % 541 4.55 2.60 2.90 0.603
Malignancy, % 559 1.24 0.00 1.27 0.736
Non-AIDS defining conditions h, % 559 0.62 0.00 0.32 1.000
Death, % 559 3.10 0.00 1.58 0.206
  1. Note: AZT = Zidovudine; CI = Confidence interval; D4T = Stavudine; EFV = Efavirenz; IQR = Interquartile range; NVP = Nevirapine; OBRs = Optimized background regimens; SD = Standard deviation; TDF = Tenofovir; 3TC = Lamivudine.
  2. aHIV-1-infected patients who simultaneously discontinued all drugs in NVP-based regimens when they experienced allergic reactions to NVP-based regimens.
  3. bHIV-1-infected patients who discontinued NVP first but continued use of the other NRTIs for a few days when they experienced allergic reactions to NVP-based regimens.
  4. cHIV-1-infected patients who were naïve to antiretroviral therapy and were never exposed to NVP before beginning EFV-based regimens.
  5. dp-value represents the difference between the three groups (Simultaneous interruption, Staggered interruption, and Control).
  6. ePatients who halted EFV-based regimens for fewer than 3 months were classified as having an EFV-based regimen interruption and remained in the study.
  7. fVirological failure was defined as either (1) having two consecutive results of plasma HIV-1 RNA >400 copies/ml after 6 month of a EFV-based regimen or (2) having plasma HIV-1 RNA >1,000 copies/ml plus having any genotypic resistance mutation to EFV-based regimen.
  8. gVirological suppression was defined as having plasma HIV-1 RNA either: (1) having plasma HIV-1 RNA <50 copies/ml (based on RT-PCR using the COBAS Amplicor HIV-1 Monitor Test Ver 1.5, Roche Molecular Systems Inc., Branchburg, NJ, USA),or (2) having plasma HIV-1 RNA <40 copies/ml (based on RT-PCR using the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 test, Roche Molecular Systems Inc., Branchburg, NJ, USA).
  9. hNon-AIDS defining conditions included major cardiovascular, renal and hepatic disease outcomes as defined by the Strategies for Management of Antiretroviral Therapy (SMART) Study Group [16].