Table 2.
Results of treatment outcomes with EFV-based regimens in eligible HIV-1-infected patients (n = 559)
| |
|
EFV-based regimens |
|
||
|---|---|---|---|---|---|
| Available data (n) | Simultaneous Interruptiona | Staggered Interruptionb | Controlsc | pvalued | |
| 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 |
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.
aHIV-1-infected patients who simultaneously discontinued all drugs in NVP-based regimens when they experienced allergic reactions to NVP-based regimens.
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.
cHIV-1-infected patients who were naïve to antiretroviral therapy and were never exposed to NVP before beginning EFV-based regimens.
dp-value represents the difference between the three groups (Simultaneous interruption, Staggered interruption, and Control).
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.
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.
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).
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].