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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 3 of 4)




                                  Adverse Effects                                    NRTIs                                              NNRTIs                          PIs           INSTI                EI


                                Hypersensitivity reaction  ABC:                                                        NVP:                                                        RAL            MVC: reported as
                                (HSR) (excluding rash      • HLA-B*5701 screening should be performed prior to         • Hypersensitivity syndrome of hepatic                                     part of a syndrome
                                alone or Stevens             initiation of ABC and ABC should not be started if HLA-     toxicity and rash that may be                                            related to
                                Johnson syndrome[SJS])       B*5701 is positive.                                         accompanied by fever, general malaise,                                   hepatotoxicity
                                                                                                                         fatigue, myalgias, arthralgias, blisters,
                                                           • Symptoms of HSR include (in descending frequency):          oral lesions, conjunctivitis, facial edema,
                                                             fever, skin rash, malaise, nausea, headache, myalgia,
                                                                                                                         eosinophilia, granulocytopenia,
                                                             chills, diarrhea, vomiting, abdominal pain, dyspnea,
                                                                                                                         lymphadenopathy, or renal dysfunction.
                                                             arthralgia, and respiratory symptoms.
                                                                                                                       • In ARV-naive patients, risk is greater for
                                                           • Symptoms worsen with continuation of ABC
                                                                                                                         women with pre-NVP CD4 count
                                                                                                                                       3
                                                           • Median onset of reactions is 9 days; ~ 90% of reactions     >250 cells/mm and men with pre-NVP
                                                                                                                                                  3
                                                             within first 6 weeks                                        CD4 count >400 cells/mm . Overall, risk
                                                                                                                         is higher for women than men.
                                                           • Onset of rechallenge reactions is within hours of
                                                             rechallenge dose                                          • 2-week dose escalation of NVP reduces
                                                                                                                         risk.
                                                           • Patients, regardless of HLA-B*5701 status, should not be
                                                             rechallenged with ABC if HSR suspected.

                                Lactic acidosis            NRTIs, especially d4T, ZDV, and ddI
                                                           • Insidious onset with GI prodrome, weight loss, and
                                                             fatigue. May be rapidly progressive, with tachycardia,
                                                             tachypnea, jaundice, muscular weakness, mental status
                                                             changes, respiratory distress, pancreatitis, and organ
                                                             failure.

                                                           • Mortality up to 50% in some case series, especially in
                                                             patients with serum lactate >10 mmol/L

                                                           • Females and obese patients at increased risk.

                                                           Laboratory findings:
                                                           • ↑ lactate (often >5 mmol/L), anion gap, AST, ALT, PT,
                                                             bilirubin

                                                           • ↑ amylase and lipase in patients with pancreatitis

                                                           •  arterial pH, serum bicarbonate, serum albumin








                              Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents                                                                                                              K-10
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