Selected Updates to the DHHS Guidelines: Rapid Initiation and Weight Gain1

Updated DHHS guidelines emphasize the importance of rapidly initiating ART after HIV diagnosis

ART REGIMENS RECOMMENDED FOR RAPID INITIATION*

Boosted DRV with FTC or 3TC plus TAF or TDF

  • Boosted DRV has a high barrier to resistance and a low rate of treatment-emergent resistance

DTG with FTC or 3TC plus TDF or TAF

  • For those of childbearing potential trying to conceive or who are not using contraception, DTG is an Alternative rather than a Preferred option, as recommended in the Perinatal Guidelines
  • DTG/3TC is not recommended in rapid initiation

BIC/TAF/FTC

  • Clinical data and experience defining the BIC barrier to resistance are relatively limited at this time
  • Similar to DTG, individuals of childbearing potential who are trying to conceive or who are not using contraception, BIC is an Alternative rather than a Preferred option, as recommended in the Perinatal Guidelines

WEIGHT GAIN CONSIDERATIONS ACCORDING TO UPDATED DHHS GUIDELINES

Greater weight gain has been associated with initiation of INSTI-containing regimens in ARV-naïve individuals than with boosted-PI regimens or NNRTIs

  • The mean increase in weight associated with BIC and DTG was similar, and greater than with EVG/c
  • Greater weight gain has also been observed after initiation of TAF or with a switch from TDF to TAF, especially in conjunction with INSTIs

INSTI-related weight gain appears to disproportionately affect female, black, and Hispanic patients

  • Black women showed the greatest increase in weight gain
  • Predictors and mechanism(s) for the weight gain are still unclear

The long-term consequences and reversibility of weight gain in ART remain unknown

  • Regional distribution of weight gain, whether the weight gain is associated with significant cardiometabolic risk, or whether it is reversible upon discontinuation of the offending agent are questions that require further clarification

*A sample for genotypic testing should be sent before initiation of ART.

DRV/c is not recommended for use in pregnancy.

Prior to use of DTG, a pregnancy test is still recommended, and providers should discuss risks versus benefits of using DTG in this specific population. Updated Botswana data showed the risk of NTDs in infants exposed to DTG at conception is higher than in those infants not exposed to DTG.

 

3TC=lamivudine; ART=antiretroviral therapy; ARV=antiretroviral; BIC= bictegravir; DHHS=Department of Health and Human Services; DRV=darunavir; DRV/c=darunavir/cobicistat; DTG=dolutegravir; EVG/c=elvitegravir/cobicistat; FTC=emtricitabine; INSTI=integrase strand transfer inhibitor; NNRTI=non-nucleoside reverse transcriptase inhibitor; NTD=neural tube defect; PI=protease inhibitor; QR=quick response; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate.

 

Reference: 1. Department of Health and Human Services. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/37/whats-new-in-the-guidelines. Updated December 18, 2019. Accessed January 16, 2020.

 

Please click here for full DHHS guidelines: https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/37/whats-new-in-the-guidelines-