Antiretroviral Agents in HIV-1 (trial)

DHHS Adult HIV 2013

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5 Table 3. Antiretroviral Regimens for Antiretroviral Therapy– Naive Patients (Updated October 2013) (cont'd) Regimens That May Be Acceptable But More Definitive Data Are Needed NNRTI-Based Regimens Î NVP i,l + ABC d /3TC b (CIII) Î RPV g +ZDV e /3TC b (CIII) CCR5 Antagonist-Based Regimen Î MVC k + (TDF/FTC b or ABC d /3TC b ) (CIII) INSTI-Based Regimen Î RAL + ZDV e /3TC b (CIII) PI-Based Regimen Î DRV/r + ZDV e /3TC b (CIII) Regimens That May Be Acceptable But Should Be Used With Caution (Regimens that have demonstrated virologic efficacy in some studies, but have safety, resistance, or efficacy concerns.) PI-Based Regimens Î SQV/r m + TDF/FTC b (CI) Î SQV/r m + (ABC d or ZDV e )/3TC b (CIII) a EFV should NOT be used during the first trimester of pregnancy or in women trying to conceive or not using effective and consistent contraception. b 3TC may substitute for FTC or vice versa. c ATV/r should NOT be used in patients who require > 20 mg omeprazole equivalent per day. d ABC should NOT be used in patients who test positive for HLA-B*5701. Use with caution in patients with high risk of cardiovascular disease or with pretreatment HIV-RNA >100,000 copies/mL. e ZDV can cause bone marrow suppression, lipoatrophy, and rarely lactic acidosis with hepatic steatosis. f If CrCl ≥70 mL/min. g RPV must be taken with a meal. It is contraindicated in patients taking proton-pump inhibitors (PPIs); use with caution with H 2 -receptor antagonists and antacids. Recommended only in patients with viral load ≤100,000 copies/mL. h Once-daily LPV/r is NOT recommended in pregnant women. i NVP should NOT be used in patients with moderate to severe hepatic impairment (Child-Pugh B or C). NVP should NOT be used in women with pre-ARV CD4 > 250 cells/mm 3 or men with pre-ARV CD4 >400 cells/mm 3 . j ATV/r is generally preferred over ATV. Unboosted ATV may be used when ritonavir boosting is not possible. k With MVC, tropism testing is required before treatment. Only patients found to have only CCR5- tropic virus are candidates for MVC. l Use NVP and ABC together with caution because both can cause hypersensitivity reactions within first few weeks aer initiation of therapy. m • SQV/r was associated with PR and QT prolongation in a healthy volunteer study. • 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 n In patients who test negative for HLA-B*5701.

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