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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 1 of 4)




                                Adverse Effects                          NRTIs                                     NNRTIs                                             PIs                           INSTI         EI


                                Bleeding events                                                                                               All PIs: ↑ spontaneous bleeding, hematuria in
                                                                                                                                              patients with hemophilia

                                                                                                                                              TPV: Reports of intracranial hemorrhage. Risks
                                                                                                                                              include CNS lesions, trauma, surgery,
                                                                                                                                              hypertension, alcohol abuse, coagulopathy, and
                                                                                                                                              concomitant use of anti-coagulant or anti-platelet
                                                                                                                                              agents including vitamin E


                                Bone marrow            ZDV: Anemia, neutropenia
                                suppression


                                Cardiovascular         ABC and ddI: Associated with MI in some                                                PIs: Associated with MI and stroke in some cohort
                                disease (CVD)          but not all cohort studies. Absolute risk                                              studies. Data on newer PIs (ATV, DRV, and TPV) are
                                                       greatest among patients with traditional                                               limited.
                                                       CVD risk factors.
                                                                                                                                              SQV/r, ATV/r, and LPV/r: PR interval prolongation.
                                                                                                                                              Risks include structural heart disease, conduction
                                                                                                                                              system abnormalities, cardiomyopathy, ischemic
                                                                                                                                              heart disease, and coadministration with drugs that
                                                                                                                                              prolong PR interval.

                                                                                                                                              SQV/r: QT interval prolongation in a healthy
                                                                                                                                              volunteer study. Risks include underlying heart
                                                                                                                                              conditions, pre-existing prolonged QT or
                                                                                                                                              arrhythmia, or use with other QT-prolonging drugs.
                                                                                                                                              ECG prior to SQV initiation is recommended and
                                                                                                                                              should be considered during therapy.


                                Central nervous        d4T: Associated with rapidly progressive    EFV: Somnolence, insomnia, abnormal
                                system (CNS) effects   ascending neuromuscular weakness            dreams, dizziness, impaired
                                                       resembling Guillain-Barré syndrome (rare)   concentration, depression, psychosis,
                                                                                                   suicidal ideation. Symptoms usually
                                                                                                   subside or diminish after 2–4 weeks.
                                                                                                   Bedtime dosing may reduce symptoms.
                                                                                                   Risks include history of psychiatric
                                                                                                   illness, concomitant use of agents with
                                                                                                   neuropsychiatric effects, and increased
                                                                                                   plasma EFV concentrations due to genetic
                                                                                                   factors or increased absorption with food.



                              Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents                                                                                                                K-8
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