Consider Real-World Challenges in Patients With HIV-1

The DHHS guidelines highlight complex treatment situations you may encounter, including adherence issues that increase patients’ risk of drug resistance, rapid initiation scenarios before resistance testing is available, or unknown resistance testing records. For each of these challenges, the DHHS guidelines recommend a regimen with a high genetic barrier to resistance, such as those containing darunavir.1

Intermittent, Suboptimal, or Poor Adherence1-7
Common real-world factors can lead to uncertain adherence

Personal Barriers

  • Complex regimen
  • Low levels of health literacy
  • Treatment-naïve
  • Busy or irregular lifestyle
  • Current substance abuse
  • Mental health issues (eg, stress, depression)
  • Psychosocial issues (eg, low social support, stigma of HIV)
  • Young age
  • Nondisclosure of HIV status
  • Nonadherence to clinical appointments
  • Difficulty with taking medication
  • Absence of HIV-1 symptoms
  • Transition from jail/prison
  • Lack of access to transportation
  • Fallen out of care

System Barriers

  • Cost and insurance issues
  • Co-pays and prior approval of medications
  • Maintaining pharmacy benefit

DHHS guidelines recommend a regimen with a high genetic barrier to resistance such as those containing darunavir when there is concern regarding a person’s adherence1

Rapid Initiation Has Been Shown to Improve Outcomes1,8-11
The benefits of engaging and rapidly treating people newly diagnosed with HIV into care may include:

Increased

  • Virologic suppression8
  • Retention in care9

Decreased

  • Time to achieve virologic suppression10
  • Mortality8

Safety data on rapid initiation, data on intermediate or long-term outcomes, and data from randomized, controlled trials conducted in high-resource settings are currently lacking1.

 

The WHO recommends rapid initiation for all people newly diagnosed with HIV-111

According to the DHHS guidelines, treatment can begin regardless of CD4+ cell count, and before resistance testing results are available for patients willing and ready to begin1.

  • Treatment may be deferred on a case-by-case basis, due to clinical and/or psychosocial factors1
  • The DHHS guidelines recommend a regimen with a high genetic barrier to resistance, such as those containing darunavir, in rapid initiation scenarios1
    • Data regarding resistance to INSTI-based regimens and the efficacy of DTG-based regimens in early HIV infection are more limited

Prior to or when initiating SYMTUZA®, test patients for hepatitis B (HBV) virus infection.

Prior to or when initiating SYMTUZA®, and during treatment with SYMTUZA®, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.

Unknown Resistance Testing Records
Some clinical situations where patients may present without HIV genotypic resistance testing records:

Treatment-naïve patients

  • Patient may have refused care at time of initial diagnosis
  • Resistance testing not performed at time of diagnosis
  • Unable to locate prior resistance records
  • Acute or recent HIV infection

Virologically suppressed patients

  • Known failure on previous regimens, but regimen type and resistance records not readily available
    • May not have been performed at time of failure
    • May not be able to locate previous genotypes if patient had transferred care
    • Viral load too low to conduct resistance testing at the time of failure

The DHHS guidelines recommend a regimen with a high genetic barrier to resistance, such as those containing darunavir, while awaiting resistance testing results or if no ARV history is available.1

ARV=antiretroviral; CD4+=cluster of differentiation 4; DHHS=Department of Health and Human Services; DTG=dolutegravir; INSTI=integrase strand transfer inhibitor; WHO=World Health Organization.

References: 1. Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents living with HIV. https://aidsinfo.nih.gov/guidelines/html/1/adult-andadolescent-arv/0. Updated October 25, 2018. Accessed January 11, 2019. 2. Schaecher K. The importance of treatment adherence in HIV. Am J Manag Care. 2013;19(12 suppl):S231-S237. 3. Sullivan PS. Campsmith ML, Nakamura GV, et al. Patient and regimen characteristics associated with self-reported nonadherence to antiretroviral therapy. PLoS ONE. 2007;2(6):e552. 4. Dunn K, Lafeuille MH, Jiao X, et al. Adherence to antiretrovirals in Medicaid insured patients living with HIV: predictors and economic consequences. Poster presented at the 9th International AIDS Society (IAS) Conference; July 23-26, 2017; Paris, France. 5. Solomon DA, Sax PE. Current state and limitations of daily oral therapy for treatment. Curr Opin HIV AIDS. 2015;10:219-225. 6. Syed ST. Gerber BS, Sharp LK. Traveling towards disease: transportation barriers to health care access. J Community Health. 2013;38(5):976-993. 7. Rozanova J, Brown S-E, Bhushan A, et al. Effect of social relationships on antiretroviral medication adherence for people living with HIV and substance use disorders and transitioning from prison. Health Justice. 2015;3(18):1-13. 8. Koenig SP, Dorvil N, Devieux JG, et al. Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial. PLoS Medicine. 2017;14(7):1-15. 9. Rosen S, Maskew M, Fox MP, et al. Initiating antiretroviral therapy for HIV at a patient’s first clinic visit: The RapIT randomized controlled trial. PLoS Medicine. 2016;13(5):1-19. 10. Pilcher CD, Ospina-Norvell C, Dasgupta A, et al. The effect of same-day observed initiation of antiretroviral therapy on HIV viral load and treatment outcomes in a U.S. public health setting. J Acquir Immune Defic Syndr. 2017; 74(1): 44–51. 11. World Health Organization. Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy. Published July 2017. https://www.who.int/hiv/pub/guidelines/advanced-HIV-disease/en/. Accessed January 11, 2019.

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