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 of 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.
See package insert for more complete information on potential side effects and interactions.
AWP$2,724.00 per box (2 vials); 10 vials for loading dose and four vials for continuing dose (every two weeks)
Potential Side Effects and Toxicity
The most common adverse reactions observed in clinical studies were diarrhea (8%), dizziness (8%), nausea (5%), and rash (5%). Additionally, select 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.
Essentially, this drug is 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 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. Patients must be on time.
Although given once every two weeks, 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, limited treatment options. Ibalizumab has been shown to work against highly drug-resistant virus, when combined with an OBR. A poster presentation at CROI 2019 showed long-term (96 week) data whereby the safety and efficacy observed at 24 weeks were maintained at Week 96. Fifteen of the 27 participants who continued in the long-term study had achieved undetectable viral load (less than 50 copies) at Week 24, and 16 were undetectable at Week 96. Furthermore, twelve patients who rolled over from a previous Phase 2 study have been on treatment with ibalizumab for an average of 8.8 years (7.8–9.5 years). For the study, as part of the OBR, investigational antivirals, including fostemsavir (see fostemsavir page), were allowed.
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. Monoclonal antibodies such as ibalizumab are transported across the placenta as pregnancy progresses; therefore, ibalizumab has the potential to be exposed to the developing fetus.
TheraPatientSupport can assist with your private or government insurance coverage, including AIDS Drug Assistance Program (ADAP) and will also assist in applying any eligible co‑pay assistance. Thera Patient Support: (833) 23-THERA (833-238-4372), therapatientsupport.com.
Dr. Ross Slotten says:
We should be thankful that a drug like Trogarzo exists. It has a novel mode of action—a monoclonal antibody, it prevents HIV from entering the CD4+ (T helper) cells, regardless of tropism (whether CCR5, CXCR4, or dual tropic). It is given as an intravenous infusion every two weeks. Except for that inconvenience, it has few side effects. If you think the wholesale cost of Biktarvy is high, don’t be surprised by this drug’s stratospheric cost—more than $100,000 per year. Alone, it will not stop HIV from advancing. For long-term benefit, it must be co-administered with at least one other drug that the person is susceptible to.
Activist Bridgette Picou says:
Ibalizumab, better known as Trogarzo, is an entry inhibitor medication for people who have tried and failed multiple classes of HIV medication and cannot achieve viral suppression. It is a monoclonal antibody, which basically means it's engineered to mimic your body’s immune system. It is not metabolized in the liver or excreted by the kidney, cutting down on those side effects. Trogarzo binds to a different CD4 cell receptor than other entry inhibitors and interferes with cell-to-cell fusion preventing virus entry. This medication is delivered via intravenous (IV) infusion every two weeks. You will continue to take your current ART regimen as it is not intended to be used alone or to replace it, but to enhance it. The infusions are usually done in office but may be arranged at home as well. Discuss scheduling with your provider as adherence is important to success.