HIV treatment guidelines by the Department of Health and Human Services (DHHS) was last updated and reviewed March of 2018 and does not include guidance on the use of Trogarzo in patients with multi-drug resistant HIV.  

DHHS guideline recommended labs when assessing treatment failure of antiretroviral therapy (ART): 

• CD4 cell count
• HIV viral load
• Resistance testing 

“HIV RNA (viral load) and CD4 T lymphocyte (CD4) cell count are the two surrogate markers of antiretroviral treatment (ART) responses and HIV disease progression that have been used for decades to manage and monitor HIV infection.”

DHHS guidelines recommend HIV-1 RNA (viral load) be checked before initiation of therapy and within 2 – 4 weeks, but no more than 8 weeks after modification of therapy due to virologic failure.  Virologic failure is defined as confirmed viral load >200 copies/mL—a threshold that eliminates most cases of apparent viremia caused by viral load blips or assay variability.  When a patient experiences virologic failure the following should be assessed adherence, drug-drug or drug-food interactions, drug tolerability, HIV RNA (viral load) and CD4 T lymphocyte (CD4) cell count trends over time, ART history, and prior and current drug-resistance testing results.  DHHS guidelines specify that Drug-resistance testing should be performed while the patient is taking the failing antiretroviral (ARV) regimen or within 4 weeks of treatment discontinuation.  For patients who are highly ART-experienced with extensive drug resistance, maximal virologic suppression by not be possible.  ART should be continued in these patients with regimens designed to minimize toxicity, preserve CD4 cell counts and delay clinical progression. 

UpToDate: “On rare occasions, there are patients with extensive resistance to multiple classes, including boosted PIs, NRTIs, and even NNRTIs. These patients often have CXCR4-using viruses and may have only an INSTI as a fully active agent. When looking for an active drug in another class to use along with the INSTI and potentially recycled NRTIs, it may be reasonable to use the monoclonal antibody ibalizumab-uiyk. This agent should be used in combination with other antiretrovirals and is administered intravenously every two weeks. In one trial that evaluated 40 patients with multidrug-resistant virus, approximately 50 percent achieved a viral load <200 copies/mL at week 25.”

Initial approval:

Trogarzo (ibalizumab-uiyk) is considered to be medically necessary when patients meet all of the following criteria:

1. Diagnosis of multidrug resistant HIV- 1 infection AND
2. Prescribed by or in consultation with an infectious disease or HIV specialist AND
3. Age ≥ 18 years AND
4. Documented HIV RNA viral load > 1,000 copies/mL in the past 8 weeks AND
5. Patient has been adherent to current antiretroviral therapy for the past 6 months AND
6. Documented resistance to at least 1 antiretroviral agent from each of the 3 classes listed below (unless contraindicated or clinically significant adverse effects are experienced):
1. NRTI (Nucleoside reverse transcriptase inhibitors)¹
2. NNRTI (Non-nucleoside reverse transcriptase inhibitors)²
3. PI (Protease inhibitors)³ AND
7. Failure of Selzentry, if CCR5-tropic, unless resistant, contraindicated, or clinically significant adverse effects are experienced AND
8. Prescribed in combination with antiretroviral therapy including at least one agent to which the patient’s virus is susceptible, if available AND
9. Dose does not exceed 2,000 mg (10 vials) IV loading dose* and/or 800 mg (4 vials) IV every 14 days.
1. *A loading dose may be repeated if the member misses scheduled maintenance dose by 3 days or more
10. Approval for 6 months  

Renewal criteria: 

Trogarzo (ibalizumab-uiyk) is considered medically appropriate for renewal if ALL of the following criteria are met:

1. Disease response indicated by a clinically significant decrease in viral load AND
2. Absence of unacceptable toxicity from the agent  

Trogarzo (ibalizumab-uiyk) is considered investigation for all other indications.

¹Nucleoside Reverse Transcriptase Inhibitors (NRTIs) include: Emtriva® (emtricitabine), Epivir® (3TC, lamivudine), Retrovir® (AZT, zidovudine), Videx-EC® (ddI, didanosine), Viread® (tenofovir DF), Zerit® (d4T, stavudine), and Ziagen® (abacavir). Several of the NRTI drugs may be combined into one tablet to make it easier to take your medications. These drugs are known as fixed-dose combinations: Combivir® (zidovoudine + lamivudine), Descovy® (tenofovir alafenamide + emtricitabine), Epzicom® (lamivudine+ abacavir), Trizivir® (zidovudine+ lamivudine+ abacavir), and Truvada® (tenofovir DF+ emtricitabine)
²Non-nucleoside reverse transcriptase inhibitors (NNRTIs) include: Edurant® (rilpivirine), Intelence® (etravirine), Rescriptor® (delavirdine), Sustiva® (efavirenz), and Viramune® (nevirapine).
³Protease Inhibitors (PIs) include: Aptivus® (tipranavir), Crixivan® (indinavir), Invirase® (saquinavir), Kaletra® (lopinavir + ritonavir), Lexiva® (fosamprenavir), Norvir® (ritonavir), Prezista®(darunavir), Reyataz® (atazanavir), and Viracept® (nelfinavir).]