Standard DoseAdministered once every two weeks via intravenous infusion. Treatment begins with an IV loading (starting) dose of 2,000 mg, followed by an 800 mg IV infusion maintenance dose given every two weeks thereafter. Must be taken in combination with another antiretroviral(s).
The first infusion takes at least 30 minutes. If no infusion-related adverse events occur, subsequent infusions take 15 minutes. Doses may be administered every two weeks at an inpatient and/or outpatient setting, including at-home infusion, if desired. All patients should be observed for 1 hour after completing first infusion. If no infusion-associated adverse reaction is noted, the post-infusion observation time can be reduced to 15 minutes. Must be given with an optimized background regimen (OBR). An OBR consists of the best antiretroviral therapy that can be made for each patient based on the patterns of HIV drug resistance in their virus. Dose modifications of Trogarzo are not required when administered with any other antiretroviral or any other treatments.
If a maintenance dose of Trogarzo is missed by 3 days or longer beyond the scheduled dosing day, a loading dose (2,000 mg) should be administered as early as possible. Then resume maintenance dosing (800 mg) every 14 days thereafter.
AWP$2,724.00 per vial; 10 vials for loading dose and two vials for continuing dose (every two weeks)
Potential Side Effects and Toxicity
- See package insert for more complete information on potential side effects and interactions.
The most common adverse reactions observed in clinical studies were diarrhea (8%), dizziness (8%), nausea (5%), and rash (5%). Additionally, selected lab abnormalities noted to occur in at least 5% of studied patients were increased bilirubin (greater than 2.6 times ULN—upper limit of normal) (5%), increased creatinine (greater than1.8 times ULN or 1.5x baseline) (10%), increased lipase (greater than 3 times ULN) (5%), decreased leucocytes (5%), and decreased neutrophils (5%). Most (90%) of the adverse reactions reported were mild or moderate in severity. No formal studies were conducted to examine the effects of either renal or hepatic impairment on the pharmacokinetics of ibalizumab. Renal impairment is not anticipated to impact the pharmacokinetics of ibalizumab.
Potential Drug Interactions
Based on Trogarzo’s mechanism of action and pharmacokinetic profile, drug-drug interactions are not expected. No drug interaction studies have been conducted with Trogarzo. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.
Essentially, this drug’s niche is deep salvage therapy for heavily treatment-experienced people with multi-drug resistance, along with an optimized background regimen (OBR). A key point is that people must still take other HIV medications that have some activity—there has to be at least one HIV drug to which their virus is sensitive included in their OBR. U.S. HIV treatment guidelines list Trogarzo this way: “Patients with ongoing detectable viremia [detectable viral load] who lack sufficient treatment options to construct a fully suppressive regimen [get to undetectable viral load] may be candidates for the recently approved CD4 post-attachment inhibitor ibalizumab.” Ibalizumab is a shiny brand new option, but it doesn’t come without some rules. It is expensive because the cost of the drug will be added to other expenses such as the time at the infusion center and qualified individuals to administer and handle the medication, although there may be an option for patients to receive their infusion at home. Non-adherence won’t be an option—people won’t be able to just show up whenever they want or be late to appointments when going to an infusion center. It will be like chemotherapy or dialysis. Patients must be on time.
Trogarzo is new and works differently than any other available HIV medication. Ibalizumab is the first HIV drug that is not taken every day. Still, because it must be used with other HIV medications, antiviral treatment will still be required to be taken daily. Ibalizumab is also the first HIV orphan drug—one that is produced for a relatively small population of patients (fewer than 200,000). It was produced for people with multi-drug resistant HIV, estimated to be fewer than 40,000 in the U.S.; the company estimates that there are fewer than 25,000. These are heavily treatment-experienced people who have multi-drug resistance, and have therefore, usually, limited treatment options. Ibalizumab has been shown to work against highly drug-resistant virus, when combined with an OBR.
Ibalizumab was studied in a relatively small (only 40 patients!) Phase 3 study. Individuals with advanced disease and limited treatment options receiving Trogarzo noted significant improvements in viral load reduction and T cell increases. After the initial loading dose, 83% of participants achieved a clinically significant decrease in viral load.
As a biologic, IBA is the first HIV medication made from cells rather than from chemicals. This does not make ibalizumab better, just different. All monoclonal antibodies (or mAbs, hence the last syllable of “ibalizumab”), are made this way, including biologics used to treat rheumatoid arthritis and psoriasis. Ibalizumab works differently from any other HIV drug currently on the market. It binds to a domain (location) of the CD4 receptor (in this case, domain 2), blocking viral entry into the CD4 cell. Ibalizumab works against both CCR5 and CXCR4 virus, and appears to be synergistic with all other classes of antiretrovirals. Resistance test results revealed no evidence of cross-resistance between Trogarzo and any of the approved classes of HIV drugs. Ibalizumab is widely considered to be an HIV entry inhibitor medication. IBA is neither metabolized in the liver nor eliminated by the kidneys. No adequate human data are available to establish whether or not Trogarzo poses a risk to pregnancy outcomes. Monoclonal antibodies such as ibalizumab are transported across the placenta as pregnancy progresses; therefore, ibalizumab has the potential to be transmitted from the mother to the developing fetus. The safety and effectiveness of Trogarzo in pediatric patients have not been established.
Dr. David Hardy says:
Trogarzo was approved by the FDA in March 2018 and is the first antiretroviral given exclusively as an intravenous (IV) infusion. Trogarzo is the first monoclonal (synthetically produced) antibody that prevents HIV from attaching to the CD4+ receptor on the surface of CD4+ T cells. Due to this specific inhibition process, HIV cannot grab onto and get inside of a PLWH’s CD4+ T cells and cause infection of that cell. A small but conclusive study showed that Trogarzo significantly dropped viral loads in PLWH with highly drug-resistant HIV when the drug was infused by vein into these persons every 2 to 4 weeks along with other antiretrovirals. The side effects of this monoclonal antibody treatment are minimal and well tolerated. It is notable that in this study, 43% (17 of 40) of PLWH also received fostemsavir as one of the active agents in an optimized treatment regimen. Also notable is the cost of Trogarzo; its monthly wholesale acquisition cost (WAC) is $9,089, or $108,960 per year.
Activist Moisés Agosto-Rosario says:
Ibalizumab is a new drug in the entry inhibitor drug class. The way it works is different from all the other antivirals. It blocks viral entry into cells by attaching to a different domain on CD4 cells. Ibalizumab works against both CCR5 and CXCR4 virus. It is not metabolized in the liver or eliminated by the kidneys. Ibalizumab is what is known as a humanized monoclonal antibody. It is the first medication to treat HIV that is not taken daily. It must be used in combination with other HIV medicines. This is what we know as a salvage therapy, meaning it is for people with multi-drug resistant HIV who cannot achieve undetectable levels of HIV. It is administrated by IV infusion.