Standard DoseLong-acting antiretroviral administered 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. An IV push formulation is being studied and would decrease administration time. Trogarzo must be given with an optimized background regimen (OBR). An OBR consists of the best antiretroviral therapy that can be made for a 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$2,969.00 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%). Select lab abnormalities noted to occur in at least 5% of studied patients were increased bilirubin by greater than 2.6 times ULN (upper limit of normal), 5%; increased creatinine (greater than 1.8 times ULN or 1.5x baseline), 10%; increased lipase (greater than 3 times ULN), 5%; decreased leukocytes, 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 Trogarzo. Renal impairment is not anticipated to affect the pharmacokinetics of Trogarzo.
Potential Drug Interactions
Based on Trogarzo’s mechanism of action and pharmacokinetic profile, drug-drug interactions are not expected. No formal 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. DHHS 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.” Trogarzo is a newer option, but it does come with some rules. 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. It is expensive because the cost of the drug will be added to other expenses such as the time at the infusion center and cost for qualified individuals to administer and handle the medication, although there may be an option for patients to receive their infusion at home. Infusions can also be done at clinics and at IV centers.
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. Trogarzo 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 there are fewer than 25,000. These are heavily treatment-experienced people who have multi-drug resistance, and have, therefore, limited treatment options. Trogarzo 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. For the study, as part of the OBR, investigational antivirals, including fostemsavir (see Rukobia page), were allowed. Trogarzo also demonstrated CD4 improvements in its clinical studies.
As a biologic, IBA is the first HIV medication made from cells rather than from chemicals. This does not make Trogarzo 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. Trogarzo 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. Trogarzo works against both CCR5 and CXCR4 virus, and may be synergistic with some other classes of antiretrovirals. Resistance test results revealed no evidence of cross-resistance between Trogarzo and any of the approved classes of HIV drugs. Trogarzo 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, Trogarzo has the potential to be exposed to the developing fetus.
Thera Patient Support can assist with private or government insurance coverage, including AIDS Drug Assistance Program (ADAP), and will also assist in applying any eligible co‑pay assistance. Commercially insured patients may be eligible for co-pay assistance and may pay as little as $0. Call (833) 23-THERA (833-238-4372), or go to therapatientsupport.com.
Dr. Melanie Thompson:
The only approved monoclonal antibody for HIV treatment, ibalizumab blocks the CD4 receptor and prevents the virus from infecting these crucial cells. It is not dependent on CCR5 or CXCR4, and is active against virus resistant to all other HIV drugs. It is only approved for people with highly resistant virus, and at least one other active drug is needed to get durable benefit. The more active drugs, the better.
It is administered intravenously every two weeks, so it is complicated to receive, and is generally administered at infusion centers but can also be arranged through home health in some situations.
A nice feature is that there are no concerns about drug interactions with Trogarzo.
It carries an astronomical price tag of over $100K per year, not counting administration costs, but there is a patient assistance program for drug costs through Theratechnologies.
With better treatments like INSTIs, the number of people with highly resistant virus is relatively small and, hopefully, will continue to decrease if people get the support they need to stay in care and on medication. Therefore, Trogarzo is a little used treatment, but very important for those who need it while waiting for new drug options.
Activist Bridgette Picou:
Another newer drug in the HIV fight is Trogarzo. It’s fascinating to me the way it fights HIV. It binds to the cell, preventing virus entry by acting like the body’s own immune system. The use of this therapy is intended for someone with multi-drug resistance across drug classes. You will continue your current regimen while taking Trogarzo. Getting an infusion every two weeks is a commitment, so you will need to work with your health care team to figure out how best it works for you. Consider your tolerability to needles and infusions before starting.