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Selzentry

maraviroc MVC (EI)
For heavily treatment-experienced people who have CCR5-TROPIC virus
Standard Dose
The recommended dose varies depending on other medications being taken but will be either 150, 300 or 600 mg twice daily (available in 150 mg and 300 mg tablets). Can be taken with or without food. Must be taken in combination with another antiretroviral(s).

Approved for adults and children weighing at least 4.4 pounds (2 kg) and having a creatinine clearance of at least 30 mL/min (measure of kidney function). Available in a 20 mg/mL oral solution. Selzentry for children is dosed based on body weight. See the package insert or HHS guidelines for weight-based dosing. The oral solution should be administered using the included press-in bottle adapter and oral dosing syringe.

Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose. Before starting Selzentry, a specific blood test called a Trofile is required to determine if this medication will work.
  • Generic and brand name available for 50 mg and 300 mg tablets. Only brand name available for oral solution 20 mg/mL.
  • See package insert for more complete information on potential side effects and interactions.
Manufacturer
ViiV Healthcare
viivhealthcare.com; selzentry.com
(877) 844-8872
AWP
150 mg, 60 tablets: $2,076.10/month
300 mg, 60 tablets: $2,076.10/month
generic: price not available at press time
Activist Comments

JUAN MICHAEL PORTER II:

Selzentry (maraviroc) is an oral pill for people who’ve developed drug resistance to other treatment options. However, it has two massive limitations: It only works for people whose HIV uses the CCR5 receptor, and it must be taken twice a day. It can be taken with or without food, but it has to be taken with other drugs and it has a number of interactions with other drugs. It’s really reserved for special cases.

Doctor Comments

JO-ANN JOSE, MD, MPH:

Maraviroc is the only approved CCR5 entry inhibitor. It is not used for initial therapy, and it’s, in fact, very rarely used. HIV needs a way to enter the cell. Think of the CCR5 receptor as the key in the lock. Using CCR5 the virus is able to attach itself and then enter the cell and spread from cell to cell. What Selzentry does is inhibit entry through CCR5. That suggests the drug only works on viruses that are CCR5 viruses; if they if they have a different tropism—or way that they enter the cell—they would not be stopped by Selzentry. A viral tropism test is required before using the drug. Selzentry requires twice-daily dosing, which can make adherence more difficult. It has many drug interactions that have to be carefully considered, some of which may require dose adjustments of Selzentry or the other drug. Because of that, it’s especially important to review with your care provider all the medications, drugs and supplements you take.

Potential Drug Interactions

Dose adjustments with other medications and anti-HIV drugs include: 150 mg twice daily if taken with medications that increase levels of Selzentry, such as boosted protease inhibitors, Stribild, Genvoya, Tybost, clarithromycin and itraconazole; 300 mg twice daily if taken with Viramune, Isentress, Tivicay, Triumeq, Fuzeon and all of the NRTIs and medications that do not affect the levels of Selzentry and 600 mg twice daily if taken with medications that decrease levels of Selzentry, such as Atripla, Sustiva, Intelence, rifampin and some anti-convulsants such as carbamazepine (Tegretol), phenobarbital and phenytoin (Dilantin). Not recommended with eslicarbazepine, oxcarbazepine, rifapentine or St. John’s wort. Selzentry may be co-administered with the hepatitis C medication Harvoni at a dose of 300 mg twice daily; however, ledipasvir (in Harvoni) may have potential to increase Selzentry levels. 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.

Potential Side Effects and Toxicity

The most common side effects occurring in greater than 8% of studied people include cough, pyrexia (fever), upper respiratory tract infections, rash, musculoskeletal symptoms, abdominal pain and dizziness. Other less common side effects may include allergic reactions, liver toxicity and heart problems in people with a history of heart disease. Rarely, Selzentry can cause dizziness or fainting when standing up due to low blood pressure. Caution should be used when administering Selzentry in people with a history of or risk factors for postural hypotension, cardiovascular comorbidities or taking concomitant medication known to lower blood pressure. Stop taking Selzentry and contact your provider right away if you develop a rash, yellowing of your eyes or skin, dark urine, vomiting or upper stomach pain. Selzentry should not be used by people with severe or end-stage kidney disease who are taking medications that can affect the level of Selzentry (check with your provider).

More Information

Not recommended by HHS as a component of an initial regimen due to requirement of CCR5 tropism testing prior to initiation of therapy, lack of virologic benefit when compared to other recommended regimens and because it requires twice-daily dosing.

Selzentry is generally recommended only when HIV medications from other classes cannot be used or when a new class of medication is needed to construct a complete and durable treatment regimen for people who have drug resistance. Complex dosing, the need for a tropism test and competition from newer drugs have dimmed some of the initial enthusiasm for this drug. In research bringing Trogarzo to market, Selzentry was often chosen to help create an optimized background regimen. Research participants had extensive HIV drug resistance. A tropism assay (Trofile, Trofile DNA or HIV-1 Coreceptor Tropism with Reflex to UDS) is needed to determine if this medication will work. Results of a phenotypic tropism test (Trofile or Trofile DNA) may take up to a month to complete. Genotypic tests are also available and may provide a faster and less expensive alternative. Learn about Selzentry’s mechanism of action at youtube.com/watch?v=oneYI0fhGa0. Selzentry only works for people with CCR5-tropic virus. Viral tropism refers to the types of HIV that a person can have, CCR5 (R5), CXCR4 (X4) or Dual-Mix Tropic (R5 and X4). Selzentry blocks CCR5, a co-receptor on the outside of a CD4 cell, and shuts down this point of entry for the virus. Most people have acquired R5 virus initially, and then over time, X4 and mixed viruses may predominate. The tropism test needed is now generally paid for by public health departments, Medicare and private insurances. ViiV may cover the payment for the Trofile test under certain circumstances.

Selzentry seems to have minimal impact on lipid levels. HHS guidelines do not recommend the use of maraviroc for treatment-naïve individuals who are pregnant. Anyone who becomes pregnant while taking maraviroc may continue if viral suppression is effective and the regimen is well tolerated. The pharmacokinetics of maraviroc are not significantly altered during pregnancy and no dosage adjustment is necessary. Maraviroc is known to have a moderate level of transfer across the human placenta, although insufficient data exist to evaluate the effects on a fetus. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; GO TO apregistry.com.