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Table 5b. Acceptable Antiretroviral Regimens for Treatment-Naive Patients


            Acceptable Regimens (CI) (Regimens that may be selected for some patients but are less satisfactory than preferred or alternative
            regimens) and Regimens that may be acceptable but more definitive data are needed (CIII)
             NNRTI-Based Regimen                               Comments
                         a
             • EFV + ZDV/3TC (CI)                              • NVP should not be used in patients with moderate to severe
                                   a
                          a
             • NVP + (TDF/FTC or ZDV/3TC ) (CI)                 hepatic impairment (Child-Pugh B or C). b
                         a
            • NVP + ABC/3TC (CIII)                             • NVP should not be used in women with pre-ART
                                                                                    3
                         a
             • RPV + ZDV/3TC (CIII)                             CD4 count >250 cells/mm or in men with pre-ART
                                                                                    3
                                                                CD4 count >400 cells/mm .
             PI-Based Regimens
                                a
             • ATV + (ABC or ZDV)/3TC (CI)                     Use NVP and ABC together with caution because both can cause
                          a
             • ATV/r + ZDV/3TC (CI)                            HSRs within the first few weeks after initiation of therapy.
                           a
             • DRV/r + ZDV/3TC (CIII)
                          a
             • FPV/r + ZDV/3TC (CI)                            ZDV can cause bone marrow suppression, lipoatrophy, and
                          a
             • LPV/r + ZDV/3TC (CIII)                          rarely lactic acidosis with hepatic steatosis.
                                                               LPV/r (twice daily) + ZDV/3TC is the preferred regimen for use
             INSTI-Based Regimen
                         a
             • RAL + ZDV/3TC (CIII)                            in pregnant women.
                                                               ATV/r is generally preferred over unboosted ATV. Unboosted ATV
             CCR5 Antagonist-Based Regimens
                          a
             • MVC + ZDV/3TC (CI)                              may be used when RTV boosting is not possible.
                                   a
                         a
             • MVC + TDF/FTC or ABC/3TC (CIII)                 Perform tropism testing before initiation of therapy with MVC.
                                                               MVC may be considered in patients who have only CCR5-tropic
                                                               virus.
             Regimens that may be acceptable but should be used with caution (Regimens that have demonstrated virologic efficacy in
             some studies but are associated with concerns about safety, resistance, or efficacy. See comments below.)
             PI-Based Regimens                                 Comments
                          a
             • SQV/r + TDF/FTC (CI)                            • SQV/r was associated with PR and QT prolongation in a healthy
                                                                volunteer study.
                                  a
             • SQV/r + (ABC or ZDV)/3TC (CIII)                 • Baseline ECG is recommended before initiation of SQV/r.
                                                               • SQV/r is not recommended in patients with any of the
                                                                following:
                                                                   1. pretreatment QT interval >450 msec
                                                                   2. refractory hypokalemia or hypomagnesemia
                                                                   3. concomitant therapy with other drugs that prolong QT
                                                                     interval
                                                                   4. complete AV block without implanted pacemaker
                                                                   5. risk of complete AV block
            a 3TC may substitute for FTC or vice versa.
            b Refer to Appendix B, Table 7 for the criteria for Child-Pugh classification
            Key to Abbreviations: 3TC = lamivudine, ABC = abacavir, ART = antiretroviral therapy, ATV = atazanavir, ATV/r = atazanavir/ritonavir,
            AV = atrioventricular, DRV/r = darunavir/ritonavir, ECG = electrocardiogram, EFV = efavirenz, FPV/r = fosamprenavir/ ritonavir, FTC = emtricitabine,
            HSR = hypersensitivity reaction, INSTI = integrase strand transfer inhibitor, LPV/r = lopinavir/ ritonavir, msec = millisecond, MVC = maraviroc,
            NNRTI = non-nucleoside reverse transcriptase inhibitor, NVP = nevirapine, PI = protease inhibitor, RAL = raltegravir, RPV = rilpivirine, RTV = ritonavir,
            SQV/r = saquinavir/ritonavir, TDF = tenofovir, ZDV = zidovudine

            Rating of Recommendations: A = Strong; B = Moderate; C = Optional
            Rating of Evidence: I = data from randomized controlled trials; II = data from well-designed nonrandomized trials or observational cohort
            studies with long-term clinical outcomes; III = expert opinion











            Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents          F-4

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