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Table 3 Adverse events of 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  
  Simultaneous Interruptiona Staggered Interruptionb Controlsc p valued
Total number, n 161 82 316  
Significant clinical adverse events e
Lipoatrophy/Lipodystrophy, % 47.2 26.8 31.0 0.001
Mitochondrial toxicityf, % 2.5 6.1 0.3 0.001
Severe anemia, % 3.1 2.4 2.9 0.957
Renal toxicity, n (%) 1 (0.6%) 0 0 0.435
CNS toxicity, n (%) 4 (2.5%) 2 (2.4%) 5 (1.6%) 0.6293
Allergic reactions to EFV, n (%) 3 (1.9%) 1 (1.2%) 4 (1.3%) 0.816
Allergic reactions to NRTIs, n (%) 1 (0.6%) 1 (1.2%) 5 (1.6%) 0.672
≥ Grade 3 laboratory adverse events g
Diabetes Mellitush, % 3.7 2.4 5.7 0.369
Hypertriglyceridei, % 5.6 2.4 2.9 0.261
Hypercholesterolemiaj, % 8.1 2.4 4.1 0.088
Transaminitisk, % 4.4 0.0 1.0 0.027
  1. Note: CNS = Central nervous system; EFV = Efavirenz; NRTI = Nucleoside analogue reverse transcriptase inhibitor.
  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. e Significant clinical adverse events was defined as clinical events that caused doctors to change or modify antiretroviral therapy.
  7. fMitochondrial toxicity was diagnosed if a patient had both (1) serum lactate ≥ 2 mmol/L, and (2) symptoms caused by NRTI toxicity such as lipoatrophy, peripheral neuropathy, and lactic acidosis.
  8. gThese events were diagnosed based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (“DAIDS AE grading table”).
  9. hDiabetes mellitus defined as a new onset with medication initiation is indicated OR uncontrolled DM despite medication modification.
  10. iTriglyceride >750 mg/dL.
  11. jCholesterol >300 mg/dL.
  12. keither AST or ALT ≥ 185 u/L.