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Single Tablet Regimens
As the category name suggests, this drug grouping combines the drugs necessary for the "cocktail" which lessens the pill burden and can help with adherence.

GENVOYA

(Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide)


DHHS Status: Recommended

Manufacturer: Gilead Sciences (www.gilead.com) Genvoya (www.genvoya.com)

FDA approval date: November 5, 2015

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

Each Genvoya tablet contains 150mg elvitegravir, 150mg cobicistat, 200mg emtricitabine, 10mg tenofovir alafenamide. A standard dose is one pill, once daily with food, in adults and children 12 years of age and older weighing at least 77 lbs.

Review: Genvoya was approved by the FDA in November of 2015 so it is a relatively new and advanced STR. Genvoya is a DHHS “Recommended” drug for first line use. It is basically a new and improved version of Stribild which is also a DHHS recommended drug for first line use. The difference between Genvoya and Stribild is Genvoya is formulated with Tenofovir Alafenamide (TAF) while Stribild is furmulated using Tenofovir Disoproxil Fumarate (TDF). This new form of Tenofovir, TAF, provides lower levels of drug in the bloodstream, but higher levels within the cells where HIV-1 replicates. It was developed to help reduce some drug side effects. Genvoya appears to be associated with less kidney toxicity (It is the only single-tablet regimen that can be given to people with impaired kidney function) and decreases in bone density than previously approved tenofovir containing regimens based on laboratory measures. Patients receiving Genvoya experienced greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in studies. The use of TAF in Genvoya also allows it to be used with the Gilead hepatitis C medication Harvoni, which is not recommended with Stribild.

Genvoya’s safety and efficacy in adults were evaluated in 3,171 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Genvoya or another FDA approved HIV treatment. Results showed Genvoya was effective in reducing viral loads and comparable to the other treatment regimens.


STRIBILD

(Elvitegravir/Cobicistat/Emtricitabine/Tenofovir)

DHHS Status: Recommended

Manufacturer: Gilead Sciences (www.gilead.com) Stribild (www.stribild.com)

FDA approval date: August 27, 2012

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

Each Stribild tablet contains 150mg of elvitegravir, 150mg of cobicistat, 200mg of Emtriva (emtricitabine) and 300mg of Viread (tenofovir). Standard dose is one pill, once a day and should be taken with food.

Review: Stribild is a single tablet, once a day HIV regimen and was approved by the FDA in August of 2012. It’s been prescribed as a regimen for initial treatment and as regimen change from Atripla, since the side effects that some experience with Atripla are not present with Stribild. Current DHHS guidelines list Stribild as a “Recommended” therapy for treatment naive patients (those starting HIV treatment).

Stribild was known prior to FDA approval as the “Quad” because of the combination of four drugs. The two points of differentiation from both Atripla and Complera in the one pill, once a day treatment category are two of the drugs in this combination. First, a differing component is Viteka (Elvitegravir), which is an integrase inhibitor. Viteka was actually approved for use in Stribild before it was approved as a stand alone drug although it was approved itself in September of 2014. Another differing component is Tybost (Cobicistat), which is not an antiviral HIV medication but a Pharmacokinetic (PK) Enhancer boosting agent used to boost the levels of other medications – it’s an alternative to Norvir, another boosting agent. Tybost was also approved for use in Stribild before it acquired stand alone status in September, 2014.

Stribild is a very strong and fantastic member of the single tablet regimen market and many find it more tolerable than Atripla.


COMPLERA

(Rilpivirine/Emtricitabine/Tenofovir)

DHHS Status: Alternative

Manufacturer: Gilead Sciences/Janssen Therapeutics (www.gilead.com),
Complera (www.complera.com)

FDA approval date: August 10, 2011

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

Each Complera tablet contains 25mg of Edurant (rilpivirine) 200mg of Emtriva (emtricitabine) and 300mg of Viread (tenofovir). Standard dose is one pill, once a day and should be taken with a meal.

Review:The current DHHS Guidelines lists Complera as an alternative therapy for those starting HIV treatment. Complera was the second single tablet once a day HIV regimen, having been approved by the FDA in August of 2011. It was downgraded from Recommended to Alternative in 2015 mostly due to it’s food requirement and viral load ceiling.

Complera is approved for use in new patients with viral loads up to 100,000 copies/mL and CD4 count higher than 200/mL also for treatment-experienced patients with undetectable viral loads that are changing regimens. It may also be considered as an alternative to Atripla by those people who experience the continued side effects of Sustiva (Efavirenz) the Non-Nuke component in Atripla.

Complera uses Janssen Therapeutics Non-Nuke Edurant (rilpivirine) which was approved by the FDA in May of 2011, rather than Sustiva which is the Non-Nuke used in Atripla. In testing, Edurant was seen to be as effective as Sustiva and may have fewer side effects in some patients.

Complera must be taken with a full, solid meal to allow for proper absorption - meal replacement shakes or protein drinks are not adequate substitutes and only allow for partial absorption so make sure you can plan a meal during the day.

The Complera tablet is smaller in size than Atripla, which can help people who have a tough time swallowing pills and obviously, being a single tablet once-a-day regimen, it cuts the pill burden.

Because of the fixed-dosing, people with kidney disease who may need a dosing adjustment shouldn’t take Complera.

A newer formulation of Complera, exchanging Viread (Tenofivir) for TAF which may lower kidney toxicity is now available in Odefsey.


ODEFSEY

(Emtricitabine/Rilpivirine/ Tenofovir Alafenamide)

DHHS Status: Alternative

Manufacturer: Gilead Sciences/Janssen Therapeutics (www.gilead.com),
Odefsey (www.odefsey.com)

FDA approval date: March 1, 2016

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

Each Odefsey tablet contains 25mg rilpivirine, 200mg emtricitabine, 25mg tenofovir alafenamide). A standard dose is one tablet taken once daily, with a standard, solid meal.

Review: Odefsey is the newest addition to the STR group having just been approved last year. As Genvoya is to Stribild, Odefsey is to Complera. Odefsey is a reformulation of Complera switching Tenofovir Disoproxil Fumarate (TDF) with Tenofovir Alafenamide (TAF). Because of the formulation with TAF, it is associated with less kidney toxicity and decreases in bone density than previously approved tenofovir (TDF) containing regimens based on laboratory testing. Odefsey is Gilead’s second TAF-based regimen to receive FDA approval and is the smallest pill of any single tablet regimen for the treatment of HIV.

Odefsey can be used by patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. Odefsey is also indicated as replacement for a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey. No dosage adjustment of Odefsey is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.


TRIUMEQ

(Dolutegravir/Abacavir/Lamivudine)

DHHS Status: Recommended

Manufacturer: ViiV Healthcare (www.viivhealthcare.com),
Triumeq (www.triumeq.com)

FDA approval date: August 22, 2014

Financial Assistance: https://www.mysupportcard.com/get-savings-card.html

A standard dose of Triumeq is one tablet (50mg dolutegravir/600mg abacavir/300 mg lamivudine) once a day, with or without food, for people with no evidence of Integrase Inhibitor resistance. An additional 50mg dose of Tivicay (dolutegravir) 12 hours apart from Triumeq is needed for people who have resistance to Isentress (raltegravir) or Viteka (elvitegravir).

Review:Triumeq was approved in August of 2014 and was formerly known as “572-Trii.” It is a single pill, once a day regimen for treatment of HIV and is “Recommended” by the DHHS in the current guidelines. Abacavir and Lamivudine are the combination that forms Epzicom, a Nucleoside Reverse Transcriptase Inhibitor. The third addition is Tivicay (Dolutegravir) which is an Integrase Inhibitor and was approved as a stand alone 2013. The addition of Tivicay (Dolutegravir) is exciting though because it is what is known as a second generation Integrase Inhibitor which means it can be an effective treatment for individuals who have shown resistance to Isentress and Elvitegravir. Tivicay also doesn’t require a booster. Because it contains abacavir, potential patients should be screened for B*5701 to decrease the risk of developing abacavir hypersensitivity before beginning Triumeq.

Since Triumeq is still relatively new, it remains to be seen how popular it will be as compared to the older, more established drugs in the category and with some of the other new entries but it’s always good to have new additions and alternatives.


ATRIPLA

(Efavirenz/Tenofovir/Emtricitabine)

DHHS Status: Alternative

Manufacturer: Bristol-myers squibb/Gilead sciences (www.bms.com),
Atripla (www.atripla.com)

FDA approval date: July 12, 2006

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

Each Atripla tablet contains 600mg of Sustiva (efavirenz), 300mg of Viread (tenofovir) and 200mg of Emtriva (emtricitabine). Standard dose is one pill, once a day, usually taken before bedtime.

Review: Atripla was downgraded from “Recommended” to “Alternative” by the Department of Health and Human Services (DHHS) in their guidelines since 2015. Atripla was the first drug that did not need to be taken with at least one other HIV medication. For years it was considered the “gold standard” and while still prescribed, newer regimens with equal potency and fewer side effects like Stribild and Complera are taking some market share away.

For the treatment-experienced, Atripla may not be an option due to drug resistance issues. Resistance can occur when medications aren’t taken as prescribed or infection can be resistant to a component in Atripla.

Some people experience psychiatric events and vivid dreams as side effects while using Atripla, which is its most common problem and for most, these diminish in severity within 4-weeks.

Atripla combines the three drugs in the standard HIV “cocktail” into one pill taken once a day and cuts the pill burden, which was of course tremendously popular from the beginning in 2006.

Atripla is recommended for adults and pediatric patients 12-years old and older with a body weight of at least 88-pounds. It is not recommended for women that are pregnant or breastfeeding. Also, because Atripla is a fixed-dose combination drug, it shouldn’t be taken by people who may need dosage adjustments such as those with kidney disease.



Single Tablet Regimens

Protease Inhibitors

Nucleoside Reverse Transcriptase Inhibitors

Non-Nucleoside Reverse Transcriptase Inhibitors

Fusion Inhibitor

Entry Inhibitor

Integrase Inhibitor

Pharmacokinetic Enhancer





Copyright 2017, Positive Health Publications, Inc.

This magazine is intended to enhance your relationship with your doctor - not replace it! Medical treatments and products should always be discussed with a licensed physician who has experience treating HIV and AIDS!