Recommended initial regimen for most people with HIV are those with demonstrated durable virologic efficacy with good tolerability:
Please see notes below if childbearing potential
INSTI + 2 NRTI
INSTI + 1 NRTI (new update to 2019 guidelines on the basis of two large randomized controlled trials that showed that a two-drug regimen of DTG/3TC was noninferior to DTG+TDF/FTC, except for individuals with HIV RNA>500,000, known active HBV, or initiating before genotype results)
Guidelines have recently been updated to favor INSTI based regimens (with 2 NRTI) as the recommended initial regimen for most people with HIV. For most patients INSTI-anchored regimens are effective with infrequent adverse effects and few drug-drug interactions.
Guidelines have recently been updated to favor INSTI-based regimens (with 1 or 2 NRTI) as the recommended initial regimen for most people with HIV. For most patients INSTI-anchored regimens are effective with infrequent adverse effects and few drug-drug interactions.
All IAS-USA recommended regimens and DHHS recommended regimens are now InSTI-based, and many are single tablet regimens. EVG/c based regimens have moved to regimens to consider in some situations, but is not considered preferred for most individuals due to the potential for drug interactions.
Comment: 48-wk results of STARTMRK, a randomized trial comparing TDF/FTC + RAL vs. TDF/FTC/EFV in ART-naive pts. Results demonstrated non-inferiority of RAL with better tolerability and fewer lipid effects. Virologic suppression more rapid with RAL, but no difference at 48 wks.
Comment: Large (N ~1800) study comparing TDF/FTC vs. ABC/3TC and ATV/r vs. EFV in naive pts. Interim review by DSMB noted more rapid time to virologic failure and grade 3/4 toxicity with ABC/3TC arm in pts with baseline VL >100,000.
Comment: ACTG 5142: landmark study comparing EFV vs. LPV/r (both + 2 NRTIs) vs. EFV+LPV/r, demonstrating superior virologic efficacy with EFV + 2 NRTIs, but statistically better CD4 response and less resistance with failure with LPV/r.
Comment: ARTEMIS: Randomized trial comparing once-daily DRV/r (800/100 mg) vs. LPV/r (gel caps or tablets, once- or twice-daily) in combination with TDF/FTC in 689 ART-naive pts., demonstrating non-inferiority of DRV/r, and superiority in pts with baseline VL >100,000. GI side effects and AEs leading to discontinuation more common with LPV/r; rash more common with DRV/r.
Comment: Final 3-yr results of GS 934, confirming superior virologic efficacy and long-term safety of TDF/FTC over AZT/3TC, with progressive differences in limb fat (lipoatrophy) over time favoring TDF/FTC arm. Also less NRTI resistance with TDF/FTC (no K65R in either arm and more M184V with AZT/3TC).
Comment: Randomized clinical trial comparing ATV/r vs. LPV/r (+ TDF/FTC) in ART-naive pts, demonstrating non-inferiority of ATV/r, with fewer GI side effects and more favorable lipid effects but more hyperblirubinemia.
Comment: Analysis of data from D:A:D study indicating that current or recent use of either ABC or ddI associated with increased risk of MI. Effects not seen for past or cumulative use of these agents. Risk no longer observed after discontinuation of drug. Increased risk restricted to MI and other coronary heart disease (CHD) outcomes but not stroke. Greatest absolute risk in pts with multiple cardiac risk factors.
Comment: 96-week data from BMS-045, a comparison of ATV/r vs. LPV/r in treatment-experienced pts. Efficacy and safety comparable; ATV/r associated w/ better GI tolerability and lipid profiles than LPV/r. Although study did not enroll naive pts, results often extrapolated to support use of ATV/RTV in naives.
Comment: 48-wk data from GS934: large, randomized, controlled trial comparing AZT/3TC + EFV vs. TDF + FTC + EFV, demonstrating greater efficacy of TDF + FTC arm due to lower toxicity (esp. anemia). Subsequently presented 96-wk data: greater virologic rebound, more M184V, and subcutaneous fat loss in AZT/3TC arm. No K65R among TDF + FTC pts at 2 yrs.
Comment: PHS guidelines on prevention of maternal-to-child transmission and use of ART in pregnant women.
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