Prezista

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AIDS virusPrezista belongs to a class of anti-HIV drugs called Protease Inhibitors (PIs). For a description of the life-cycle of the AIDS virus, and the targets of each class of drugs, click here.

Prezista is marketed by Janssen Therapeutics. They have a useful web site that includes additional information about this drug: Click here.

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Prezista (darunavir)

Pronunciation(s): pre-ZIS-ta; da-ROO-nuh-veer



What is Prezista?
  • Prezista is an HIV medication. It is in a category of HIV medicines called protease inhibitors. Prezista prevents cells infected by HIV from producing new virus. This reduces the amount of virus in your body.
     
  • Prezista must be used with low-dose Norvir (ritonavir) and in combination with other HIV drugs.
     
  • Prezista, manufactured by Janssen Therapeutics, was initially approved by the U.S. Food and Drug Administration (FDA) on June 23, 2006, for treatment-experienced HIV-positive adults. It was approved for HIV-positive people beginning treatment for the first time on October 22, 2008.
     
  • Janssen Therapeutics has established a patient assistance program (PAP) for people living with HIV who do not have private or public health insurance and are unable to afford Prezista. To learn more about the PAP for Prezista, call 866-836-0114 or refer to Tibotec's website for more information. For those with private health insurance, Tibotec has established a program to help cover up to 80 percent of the amount of each Prezista co-payment, up to $100 every month. To learn more about this co-pay program, call 866-961-7169.

What is known about Prezista?
  • There are two approved adult doses for Prezista:

    Once-Daily Dose: One 800 mg Prezista tablet (or two 400 mg Prezista tablets) plus one 100 mg Norvir tablet once a day for people who have never taken antiretroviral drugs and for treatment experienced individuals who do not carry any Prezista resistance HIV mutations.

    Twice-Daily Dose: One 600 mg Prezista tablet plus one 100 mg Norvir tablet twice a day for treatment experienced individuals who carry one or more Prezista resistance HIV mutations.
     
  • Prezista, combined with Norvir, should be taken with food. The type and amount of food is not important. In other words, Prezista/Norvir can be taken with a full meal or a light snack.
     
  • For HIV-positive adults beginning HIV drug therapy for the first time, Prezista is listed as a "preferred" protease inhibitor option by the United States Department of Health and Human Services in its treatment guidelines. To learn more about these recommendations and options, click here.
     
  • Prezista is recommended by the U.S. Department of Health and Human Services (DHHS) for HIV-positive people who have tried and failed other protease inhibitors in the past.
     
  • Clinical trials have demonstrated that Prezista is an effective option for patients who are not likely to respond to older protease inhibitors, especially when it is combined with other HIV medications that a patient's virus is still at least partially sensitive to.
     
  • Prezista works best when it is combined with HIV drugs that the virus is still sensitive to. However, this can be challenging for HIV-positive people who have tried several HIV drug regimens in the past. Drug resistance tests, such as genotypic assays and phenotypic assays, and treatment history, can be very useful in figuring out which HIV drugs the virus is still likely to respond to.
     
  • Prezista is not approved for use in HIV-positive children under 3 years of age. A liquid formulation of the drug is available, for children and adults who cannot swallow Prezista pills. To learn more about treatment options for children, click here.

What about drug interactions?
  • Because of the ways Prezista and Norvir are metabolized (broken down) in the body, they can interact with many other medications used to treat HIV, AIDS-related complications, and other diseases. Prezista/Norvir may cause blood levels of other medications to be become too low (which can decrease their effectiveness) or high (which can increase the risk of side effects). Similarly, other medications may cause blood levels of Prezista and/or Norvir to become too low or high.
     
  • Tell your doctors and pharmacists about all medicines you take. This includes those you buy over-the-counter and herbal or natural remedies, such as St. John's wort. Bring all your medicines when you see a doctor, or make a list of their names, how much you take, and how often you take them. Your doctor can then tell you if you need to change the dosages of any of your medications.
     
  • The following medications should not be taken while you are being treated with Prezista/Norvir (this list includes medications that are contraindicated—should not be taken together—according to both the Prezista and Norvir packaging information):
    Antifungals: Vfend (voriconazole)
    Anti-seizure medications:
    Tegretol (carbamazepine), Luminal (phenobarbital), Dilantin ( phenytoin)
    Acid reflux/heartburn medications: Propulsid (cisapride)
    Antibiotics: Rifadin (rifampin)
    Antimigraine medications: Methergine, Methylergometrine (methylergonovine); Ergostat, Cafergot, Ercaf, Wigraine (ergotamine); Ergotrate, Methergine (ergonovine); or D.H.E. 45, Migranal (dihydroergotamine)
    Antihistamines: Hismanal (astemizole) or Seldane (terfenadine)
    Cholesterol-lowering drugs (statins): Zocor (simvastatin) and Mevacor (lovastatin)
    Heart medications: Cordarone (amiodarone), Vascor (bepridil), Tambocor (flecainide), Rythmol (propafenone), or Quinaglute/Quinidex (quinidine)
    Antipsychotics: Orap (pimozide)
    Sedatives: Versed (midazolam) and Halcion (triazolam)
    Enlarged prostate: Uroxatral (alfuzosin)
    Pulmonary Hypertension: sildenafil, used as Revatio
    Herbal products:
    St. John's wort
     
  • HIV protease inhibitors can interact with Prezista/Norvir. Kaletra (lopinavir/ritonavir) and Invirase (saquinavir) can significantly decrease blood levels of Prezista, hence it is not recommended that Prezista be combined with Kaletra or Invirase. Taking Prezista and Crixivan together can cause the levels of both drugs to increase in the bloodstream. Prezista/Norvir does not appear to increase or decrease blood levels of Reyataz (atazanavir), nor does Reyataz appear to increase or decrease blood levels of Prezista/Norvir. In turn, it may be possible to combine these two PIs.
     
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs) can also interact with Prezista/Norvir. Prezista/Norvir can increase levels of Sustiva (efavirenz) [and to a lesser extent Viramune (nevirapine)] in the blood. Combining Prezista/Norvir with Sustiva should be done with caution.
     
  • Prezista/Norvir can increase levels of Viread (tenofovir), a nucleotide reverse transcriptase inhibitor, in the blood. However, these two drugs can be combined without any dose adjustments (although it may be necessary to watch carefully for kidney damage, a potential side effect of Viread). Videx/Videx EC (didanosine) must be taken on an empty stomach. In turn, if Videx/Videx EC is used in the same regimen as Prezista/Norvir, it should be taken one hour before or two hours after Prezista/Norvir (which should be taken with food).
     
  • Prezista/Norvir can interact with some medications used to treat thrush (candidiasis) and other fungal infections. Prezista/Norvir increases Nizoral (ketoconazole) and may increase Sporanox (itraconazole) levels in the bloodstream. For people taking Prezista/Norvir who also need to take Sporanox or Nizoral, the daily dose of Sporanox or Nizoral should not exceed 200mg. It is also possible that Prezista/Norvir decreases Vfend (voriconazole) levels in the blood (Vfend should not be taken if you are on an HIV drug regimen that contains Norvir).
     
  • Prezista/Norvir can interact with some medications used to treat TB, MAC, and other bacterial infections. Prezista/Norvir raises Biaxin (clarithromycin) levels in the bloodstream. The dose of Biaxin does not need to be decreased, although this is recommended in people with altered kidney function. Prezista/Norvir can also increase Mycobutin (rifabutin) levels in the bloodstream (Mycobutin can also increase Prezista levels in the bloodstream). If Mycobutin is taken at the same time as Prezista/Norvir, it is recommended that the Mycobutin dose be reduced to 150mg every other day. Prezista/Norvir should not be used with Rifadin (rifampin), a common antibiotic used to treat TB.
     
  • Prezista/Norvir may interact with calcium channel blockers, medications used to treat heart disease. Studies of Prezista/Norvir combined with calcium channel blockers have not yet been conducted. Healthcare providers should be cautious when prescribing Prezista/Norvir with either Cardizem (diltiazem), Plendil/Lexxel (felodipine), Cardene (nicardipine), Sular (nisoldipine), or Calan/Verelan (verapamil). Prezista/Norvir can increase the blood levels of the heart medications Vascor (bepridil), lidocaine, Quinidex (quinidine) and Cardarone (amiodarone). These medications should be used with caution if taken with Prezista/Norvir and monitoring blood levels of these drugs is recommended, if available. Prezista/Norvir can also significantly increase blood levels of Lanoxin (digoxin). The lowest dose of Lanoxin should initially be used and monitoring Lanoxin blood levels is recommended.
     
  • Prezista/Norvir can decrease levels of the blood thinner Coumadin (warfarin) in the bloodstream. Conducting blood coagulation (clotting) testing may be necessary.
     
  • Prezista/Norvir may increase blood levels of Norpramin (desipramine), a drug used to treat depression. The dose of Norpramin may need to be decreased. Prezista/Norvir may also decrease levels of Zoloft (sertraline) and Paxil (paroxetine). It may be necessary to increase Zoloft of Paxil dosing if also using Prezista/Norvir.
     
  • Cholesterol-lowering drugs, also known as "statins," can interact with Prezista/Norvir. There are two statins that should not be used with Prezista/Norvir: Zocor (simvastatin) and Mevacor (lovastatin). Levels of these two drugs can become significantly increased in the bloodstream if they are combined with Prezista/Norvir, which increases the risk of side effects. The statin believed to be the safest in combination with Prezista/Norvir is Lescol (fluvastatin). It is also possible to take Prezista/Norvir with Lipitor (atorvastatin), or Crestor (rosuvastatin) although Prezista/Norvir can increase the level of these drugs in the bloodstream (if Lipitor or Crestor are prescribed, it's best to begin treatment with the lowest possible dose of the drug and then increase the dose if necessary or else use a different drug.) While the FDA-approved packaging information for Prezista suggests that Pravachol (pravastatin) can also be used, Tibotec does not recommend combining Pravachol with Prezista/Norvir.
     
  • Prezista can increase blood levels of cochicine, which is used to treat gout. Lower doses of colchicine are recommended, and the two drugs should not be used together in people with liver or kidney impairment.
     
  • Neoral, Sandimmune, Gengraf (cyclosporine), Prograf (tacrolimus), Rapamune (sirolimus) are all examples of immune-suppressants, often prescribed for patients who have undergone an organ/tissue transplant. Prezista/Norvir can increase levels of these drugs in the blood. In turn, it is necessary to carefully monitor blood levels of these drugs if they are combined with Prezista/Norvir.
     
  • Prezista/Norvir can increase blood levels of Advair, Flovent, or Flonase (fluticasone), the inhalable medications that are used to treat allergies and asthma. In turn, these drugs may decrease blood levels of Prezista/Norvir. Alternatives to these drugs should be considered, especially for long-term use. Prezista can increase blood levels of an asthma medication called Serevent (salmeterol), a drug that is used to open the air passages in the lungs during an asthma attack. This can result in heart rhythm problems. Use of the two drugs together is not recommended.
     
  • Another painkiller, methadone, commonly used to treat drug heroin addiction, can interact with Prezista/Norvir. Methadone levels in the bloodstream can decrease when combined with Prezista/Norvir. Because of this, it might be necessary to increase the dose of methadone.
     
  • Desyrel (trazodone) is used to treat depression. Prezista/Norvir can increase blood levels of this drug, leading to an increase risk of Desyrel side effects. Using a lower dose of Desyrel may be necessary.
     
  • Prezista/Norvir decreases the amount of oral contraceptives (taken by women to help avoid pregnancy) in the bloodstream. This means that there may be a higher risk of becoming pregnant if Prezista/Norvir and oral contraceptives are taken at the same time. To reduce the risk of pregnancy, barrier protection (e.g., condoms) should be used.
     
  • There is a class of drugs, known as PDE-5 inhibitors that are used to treat both erectile dysfunction and pulmonary arterial hypertension. Their brand names differ, depending on their use. Prezista/Norvir can significantly increase blood levels of these drugs.

    When used to treat erectile dysfunction, it is best to use a lower dose of Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil) in order to reduce the risk of side effects. When used to treat pulmonary arterial hypertension, the dose of tadalafil (Adcirca) must be reduced if combined with Prezista/Norvir. Revatio (sildenafil) and Prezista/Norvir should not be used together.

  • Tracleer (bosenstan) is another type of drug used to treat pulmonary arterial hypertension, called an endothelin receptor antagonist. Prezista/Norvir can increase Tracleer blood levels, so the dose of Tracleer should be reduced. 


What is known about side effects?
  • The most common side effects reported by patients taking Prezista and Norvir in clinical trials included diarrhea, nausea, headache, and abdominal pain. Some patients receiving Prezista/Norvir experienced skin rashes; most were mild-to-moderate. If a severe rash occurs while taking Prezista/Norvir, patients should contact their healthcare providers immediately.
     
  • Prezista, a sulfa-containing drug, should be used with caution in patients with a known sulfa allergy.
     
  • Some people may experience large increases in their lipid levels (triglycerides and cholesterol) while being treated with protease inhibitors. However, it is not yet known what effect, if any, Prezista will have on lipids. Click here for more information on HIV treatment and lipid increases.
     
  • Diabetes and high blood sugar may occur in people who take Prezista or other protease inhibitors.
     
  • HIV drug regimens containing protease inhibitors, including Prezista/Norvir, may cause abnormal body-shape changes (lipodystrophy; including increased fat around the abdomen, breasts, and back of the neck, as well as decreased fat in the face, arms, and legs). These side effects of HIV drug therapy are reviewed in our lesson on lipodystrophy.
     
  • HIV medications, such as Prezista, can increase the risk of bleeding in hemophiliacs.
     
  • Drug-induced hepatitis (liver injury) has been reported in people taking Prezista. This usually occurred in people who had extremely low CD4 cells, were taking multiple other medications and who were also infected with hepatitis B virus (HBV) and/or hepatitis C virus (HCV). People taking Prezista who are coinfected with HBV or HCV, or who have a history of liver damage, should have their liver function closely monitored by their healthcare providers. Stopping Prezista treatment may be necessary, in consultation with a healthcare provider, in the case of abnormal liver enzymes or symptoms of liver damage (i.e. fatigue, nausea, yellow eyes and skin, dark urine and liver tenderness).

Who should not take Prezista?
  • People with mild to moderate liver damage (hepatic impairment) may use Prezista without changing the dose. Prezista has not been studied in people with severe hepatic impairment and it is not recommended in people with severe hepatic impairment. 

Can pregnant women take Prezista?
  • Prezista is classified by the FDA as a pregnancy category B drug. Pregnancy category B means that animal studies have failed to demonstrate a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. HIV-positive women who become pregnant should discuss the benefits and possible side effects of HIV treatment to help protect their babies from HIV (see our lesson called Family Planning, Pregnancy & HIV).
     
  • It is not known whether Prezista passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.

Where can I learn more about clinical trials of Prezista?
  • If you would like to find out if you are eligible for any clinical trials that include Prezista, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email contactus@aidsinfo.nih.gov.

Last Revised: November 14, 2012

This content is written by the POZ and AIDSmeds editorial team. For more information, please visit our "About Us" page.


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