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

Table 3 Adverse events of EFV-based regimens in eligible HIV-1-infected patients (n = 559)

	EFV-based regimens
	Simultaneous Interruption^a	Staggered Interruption^b	Controls^c	p value^d
Total number, n	161	82	316
*Significant clinical adverse events* ^e
Lipoatrophy/Lipodystrophy, %	47.2	26.8	31.0	0.001
Mitochondrial toxicity^f, %	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 Mellitus^h, %	3.7	2.4	5.7	0.369
Hypertriglycerideⁱ, %	5.6	2.4	2.9	0.261
Hypercholesterolemia^j, %	8.1	2.4	4.1	0.088
Transaminitis^k, %	4.4	0.0	1.0	0.027

Note: CNS = Central nervous system; EFV = Efavirenz; NRTI = Nucleoside analogue reverse transcriptase inhibitor.
^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).
^e Significant clinical adverse events was defined as clinical events that caused doctors to change or modify antiretroviral therapy.
^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.
^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”).
^hDiabetes mellitus defined as a new onset with medication initiation is indicated OR uncontrolled DM despite medication modification.
ⁱTriglyceride >750 mg/dL.
^jCholesterol >300 mg/dL.
^keither AST or ALT ≥ 185 u/L.

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