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DHHS Status: Recommended in Combination as Initial Regimen in Certain Clinical Situations

Manufacturer: Janssen Therapeutics (www.janssentherapeutics.com)
Prezista (www.prezista.com)

FDA approval date: June 23, 2006

Financial Assistance: www.prezista.com/patients/ assistance-and-support/patient-assistance-program

The standard dose of Prezista for people just starting treatment and the treatment-experienced without Prezista-related resistance is one 800mg tablet plus one 100mg Norvir or 150mg Tybost capsule once-a-day. For treatment experienced patients who have had Prezista-related resistance or women who are pregnant, it is one 600mg tablet and one 100mg Norvir capsule twice a day. Prezista should be taken with food and should always be taken with Norvir. 75mg and 150mg tablets are available for children 3-years old and older, dosage is based in the child’s weight.

Review: Prezista boosted with Norvir is listed as “Recommended as Initial Regimen in Certain Clinical Situations” in the latest DHHS guidelines. Unlike, Reyataz, Prezista should not be taken without Norvir or Tybost as a booster. Prezista, on January 29th of 2015, was approved in combination with Gilead Science’s pharmacokinetic enhancer drug, Tybost (cobicistat) as Prezcobix (see next). This formulation reduces the pill burden, some co-pay expenses and also help people who don’t tolerate Norvir well. A single-tablet, once-daily regimen containing darunavir/cobicistat/emtricitabine/tenofovir alafenamide is expected to be approved this year. Prezista boosted with Norvir is a preferred component in the DHHS perinatal guidelines.

Prezista is available in an oral solution which can be preferable for children and people who have problems swallowing pills but it must also be boosted with Norvir or Tybost and also taken with food.

DHHS Status: Recommended in Combination as Initial Regimen in Certain Clinical Situations

Manufacturer: Janssen Therapeutics (www.janssentherapeutics.com)
Prezcobix (www.prezcobix.com)

FDA approval date: January 29, 2015

Financial Assistance: https://www.prezcobix.com/patient-support/janssen-carepath

A standard dose of Prezcobix is one tablet (800mg darunavir/150mg cobicistat), once daily with food, in patients with no darunavir drug resistance.

Review: Prezcobix was approved by the FDA on January 29th of 2015 and is rated by the DHHS in their current guidelines as “ Recommended in Combination as Initial Regimen in Certain Clinical Situations.”

The key component of Prezcobix, Prezista (darunavir) holds the same DHHS status and Tybost (cobicistat) received approval as a pharmacokinetic (PK) enhancer in 2015.

Tybost has been formulated as a single pill with both Reyataz to form EvoTaz and with Prezista in this case to form Prezcobix. In both, it will help people who do not tolerate Norvir well (especially with Prezista since the addition of Norvir is a must), help with pill burden by reducing down to just one pill (although a larger one) and will help with the co-pay and expense of eliminating Norvir. A single-tablet, once-daily regimen containing darunavir/cobicistat in combination with emtricitabine/tenofovir alafenamide is expected to be approved this year.

DHHS Status: Recommended in Combination as Initial Regimen in Certain Clinical Situations

Manufacturer:Bristol-Myers Squibb (www.bms.com) Reyataz (www.reyataz.com)

FDA approval date: June 20, 2003

Financial Assistance: https://www.bms3assist.com/bms3assist/

A standard dose of Reyataz is one 300mg capsule and one 100mg Norvir capsule or 150mg of Tybost, taken with food once a day. Those who cannot tolerate Norvir can take two 200mg capsules of Reyataz with food once a day, as an alternative.

Review: Reyataz was downgraded to an “Alternative” regimen by the DHHS in their previous guidelines mostly due to some side effect problems with mild jaundice and tolerability issues. It is now listed as “ Recommended in Combination as Initial Regimen in Certain Clinical Situations.” Reyataz is usually boosted with Norvir (ritonavir). If the boosting agent, Norvir, is hard to tolerate by some, Reyataz can be used by itself in higher doses or with Tybost. Reyataz received FDA approval on January 29th of 2015 in combination with a newer, approved PK Enhancer, Tybost (cobicistat) which is a built-in booster. The newly formulated and approved drug is Evotaz (see next). This formulation lessen the pill burden and also eliminates the need for Norvir.

The pluses for Reyataz are that it has a very convenient dosing, there is less diarrhea associated with it and Reyataz doesn’t seem to raise your cholesterol and triglyceride levels the way most other protease inhibitors do. In fact, one study suggests that Reyataz may actually increase your HDL (good) cholesterol, which helps protect you from heart disease.
Reyataz can be taken by women who are pregnant and is recommended for use during pregnancy according to the DHHS guidelines. Reyataz can also be taken in combination with Norvir by children aged 6 and older.

DHHS Status: Recommended in Combination as Initial Regimen in Certain Clinical Situations

Manufacturer: Bristol-Myers Squibb (www.bms.com)

Evotaz (www.evotaz.com)

FDA approval date: January 29, 2015

Financial Assistance: https://www.evotaz.bmscustomerconnect.com/patients-caregivers/assistance-program

A standard dose of EvoTaz is one tablet (300mg atazanavir/150 mg cobicistat) once daily with food.

Review: EvoTaz was approved by the FDA January 29th of 2015 and is listed as “Recommended in Combination as Initial Regimen in Certain Clinical Situations” for HIV therapy in the current DHHS guidelines. Atazanavir, it’s key component, has been recommended for years and holds the same DHHS status and Tybost (cobicistat) has been approved since 2014.

EvoTaz uses the PK Enhancer, Tybost (cobicistat) as a built-in booster. This eliminates the need for the stand alone booster Norvir. The built-in booster, Tybost, is a more tolerable formulation for those who have trouble with Norvir plus it lowers pill burden and lessens co-pays.

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