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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].