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Table 13. Antiretroviral Therapy-Associated Common and/or Severe Adverse Effects

(See Appendix B for additional information listed by drug.) (Page 2 of 4)

Adverse Effects NRTIs NNRTIs PIs INSTI EI

Diabetes mellitus ZDV, d4T, and ddI • Reported for some PIs (IDV, LPV/r), but
(DM)/insulin not all PIs studied
resistance
• ATV +/- RTV not found to alter insulin
sensitivity of HIV-uninfected individuals in
short-term studies.

Dyslipidemia d4T > ZDV > ABC: EFV  LDL,  TG,  HDL: all RTV-boosted PIs
•  LDL and TG •  TG
•  LDL  TG:
LPV/r = FPV/r and LPV/r > DRV/r and ATV/r
•  HDL

Gastrointestinal Nausea and vomiting: GI intolerance (diarrhea, nausea, vomiting)
(GI) effects ddI and ZDV > other NRTIs
Diarrhea:
Pancreatitis: ddI common with NFV. LPV/r > DRV/r and ATV/r

Hepatic effects Reported for most NRTIs NVP > other NNRTIs All PIs: Drug-induced hepatitis and hepatic MVC:
NVP: decompensation (and rare cases of fatalities) Hepatotoxicity
ddI: Prolonged exposure linked to
have been reported with all PIs to varying with or without
noncirrhotic portal hypertension, • Severe hepatic toxicity with NVP is often associated degrees. The frequency of hepatic events is rash or HSRs
some cases with esophageal with skin rash or symptoms of hypersensitivity. higher with TPV/r than with other PIs. reported
varicees
• For ARV-naive patients, risk is greater for women IDV, ATV: Jaundice due to indirect
3
Steatosis: Most commonly seen with pre-NVP CD4 count >250 cells/mm and men
3 hyperbilirubinemia
with ZDV, d4T, or ddI with pre-NVP CD4 count >400 cells/mm . Overall
risk is higher for women than men. TPV/r: Contraindicated in patients with
Flares: HIV/HBV-coinfected moderate to severe hepatic insufficiency
patients may develop severe • Risk is greatest in the first few months of treatment. (Child-Pugh classification B or C)
hepatic flare when TDF, 3TC, and
• 2-week dose escalation of NVP reduces risk of rash
FTC are withdrawn or when HBV
resistance develops. and possibly hepatotoxicity if related to
hypersensitivity.

• NVP is contraindicated in patients with Child-Pugh
classification B or C.

• Liver failure observed in HIV-uninfected individuals
receiving NVP for post-exposure prophylaxis. NVP
should never be used for this indication.

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents K-9
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