Antiretroviral Guidelines

US DHHS Guidelines with Autralian commentary


Transgender People with HIV


Last Updated: July 10, 2019; Last Reviewed: July 10, 2019

Panel’s Recommendations


  • Antiretroviral therapy (ART) is recommended for all transgender people with HIV to improve their health and to reduce the risk of HIV transmission to sexual partners (AI).
  • HIV care services should be provided within a gender-affirmative care model to reduce potential barriers to ART adherence and maximize the likelihood of achieving sustained viral suppression (AII).
  • Prior to ART initiation, a pregnancy test should be performed for transgender individuals of childbearing potential (AIII).
  • Some antiretroviral (ARV) drugs may have pharmacokinetic interactions with gender-affirming hormone therapy. Clinical effects and hormone levels should be monitored routinely with appropriate titrations of estradiol, testosterone, or androgen blockers, as needed (AIII).
  • Gender-affirming hormone therapies are associated with hyperlipidemia, elevated cardiovascular risk, and osteopenia; therefore, clinicians should choose an ART regimen that will not increase the risk of these adverse effects (AIII).
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

Potential Interactions Between the Drugs Used in Gender-Affirming Hormone Therapy and Antiretroviral Drugs


Potential Effect on GAHT Drugs ARV Drugs GAHT Drugs that may be Affected by ARV Drugs Clinical Recommendations for GAHT
ARV Drugs with the Least Potential to Impact GAHT Drugs All NRTIs 

Entry Inhibitors:
  • IBA
  • MVC
  • T-20
Unboosted INSTIs:
  • BIC
  • DTG
  • RAL
NNRTIs:
  • RPV
  • DOR
None No dose adjustments necessary. Titrate dose based on desired clinical effects and hormone concentrations.
ARV Drugs that may Increase Concentrations of Some GAHT Drugs EVG/c 

All boosted PIs
Dutasteride

Finasteride

Testosterone
Monitor patient for associated adverse effects; decrease the doses of GAHT drugs as needed to achieve the desired clinical effects and hormone concentrations.
ARV Drugs that may Decrease Concentrations of GAHT Drugs PI/r

NNRTIs:
  • EFV
  • ETR
  • NVP
Estradiol Increase the dose of estradiol as needed to achieve the desired clinical effects and hormone concentrations.
NNRTIs:
  • EFV
  • ETR
  • NVP
Dutasteride

Finasteride

Testosterone
Increase the doses of GAHT drugs as needed to achieve the desired clinical effects and hormone concentrations.
ARV Drugs with an Unclear Effect on GAHT Drugs EVG/c 

PI/c
Estradiol There is the potential for increased or decreased estradiol concentrations. Adjust the dose of estradiol to achieve the desired clinical effects and hormone concentrations.
Note: See Tables 21a, 21b, 21c, 21d, and 21e for additional information regarding drug-drug interactions between ARV drugs and gender-affirming medications. 

Key: ARV = antiretroviral; BIC = bictegravir; DOR = doravirine; DTG = dolutegravir; EFV = efavirenz; ETR = etravirine; EVG/c = elvitegravir/cobicistat; GAHT = gender-affirming hormone therapy; IBA = ibalizumab; INSTI = integrase strand transfer inhibitor; MVC = maraviroc; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NVP = nevirapine; PI = protease inhibitor; PI/c = protease inhibitor/cobicistat; PI/r = protease inhibitor/ritonavir; RAL = raltegravir; RPV = rilpivirine; T-20 = enfuvirtide