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DHHS Status: Recommended in Combination as Initial Regimen for Most People with HIV

Manufacturer: Gilead Sciences (www.gilead.com) Truvada (www.truvada.com)

FDA approval date: August 2, 2004

Financial Assistance: https://www.truvada.com/truvada-patient-assistance

Each Truvada tablet contains 200mg of Emtriva (emtricitabine) and 300mg of Viread (tenofovir). Standard dose is one capsule a day and can be taken with or without food.

Review: Truvada is an outstanding combination drug that allows you to take two-thirds of your drug regimen in one pill, taken once a day. Truvada is the NRTI (Nuke) component in both Atripla (where it is combined with Sustiva) and Complera (where it is combined with Edurant). Truvada is also the NRTI component of Striblid. As a stand-alone drug, it is considered “Recommended as component of initial regimen for most people with HIV” by the latest DHHS guidelines. A new, reformulated version of Truvada, substituting tenofovir alafenamide (TAF) for tenofovir disoproxil fumarate (TDF), was approved in 2016 and is Descovy (see next) it is also DHHS “Recommended as component of initial regimen for most people with HIV” for use in first line therapy. Less kidney and bone issues are present with TAF than TDF in clinical trials. The Truvada to Descovy reformulation is Gilead Science’s third reformulation using TAF in place of TDF.

Truvada For PrEP
Truvada was approved by the FDA in July of 2012 for HIV prevention – Pre-exposure Prophylaxis (PrEP) used by people who are currently HIV-negative. Clinical studies showed that HIV-negative individuals who took Truvada for PrEP everyday and who combined it with condoms (and other HIV prevention methods) can see their HIV risk cut considerably. This is true for both women and men for both vaginal and anal sex. The reformulated, Descovy has not been approved for PrEP use. Unlike using Truvada for HIV treatment, using Truvada for PrEP can be used for short periods of time when a HIV-negative individual might be at risk for exposure. Truvada for PrEP takes about 7-days to reach protective levels in the rectal tract and about 21-days to reach protective levels in the vaginal tissue. For more information on Pre-exposure Prophylaxis (PrEP) consult your physician and go to www.truvadapreprems.com. Lactic Acidosis (a build-up of acid in the blood) is a potential side effect and persons with kidney disease may not be candidates to use Truvada.

Truvada is a fantastic and multifaceted drug.

DHHS Status: Recommended in Combination as Initial Regimen for Most People with HIV

Manufacturer: Gilead Sciences (www.gilead.com)

Descovy (www.descovy.com)

FDA approval date: April 4, 2016

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

Each Descovy tablet contains 200mg emtricitabine and 25mg tenofovir alafenamide. Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV infection in adults and pediatric patients 12 years of age and older. Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults at high risk.

Review: Descovy is Recommended in combination as initial regimen for most people with HIV in current DHHS guidelines. One of the newer of all the approved drugs, being approved in April, 2016, and as the first new HIV treatment backbone that had been approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care. As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer a simple and effective combination with a safety profile that has the potential to improve health.

Descovy was the third drug that Gilead Sciences offered that is reformulated using Tenofovir Alafenamide (TAF) rather than Tenofovir Disoproxil Fumarate. Basically, it is a reformulation of the extremely successful drug Truvada. A clinical trial is currently in progress comparing Descovy to Truvada for PrEP. Descovy is also recommended by DHHS for individuals co-infected with both HIV and hepatitis B.

TAF has demonstrated improvement in surrogate laboratory markers of kidney and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.

DHHS Status: Recommended in Combination as Initial Regimen for Most People with HIV

Manufacturer: Gilead Sciences (www.gilead.com) Emtriva (www.gilead.com)

FDA approval date: July 2, 2003

Financial Assistance: https://www.gilead.com/responsibility/us-patient-access/us-advancing-access

The standard dose of Emtriva is one 200mg pill once a day. With or without food.

Review: Emtriva is an extremely popular and effective drug. It is also very easy to tolerate. It is usually not prescribed for use by itself however, Emtriva is combined with Viread to form the combination drug Truvada and is also combined to form Descovy (see prior). Truvada is a DHHS “Recommended in combination as initial regimen for most people with HIV” NRTI for first time therapy and was also approved in July of 2012 for HIV prevention Pre-exposure Prophylaxis (PrEP) for HIV negative individuals. For more information on PrEP, go online to www.truvadapreprems.com. Descovy is also DHHS “Recommended in combination as initial regimen for most people with HIV” for first time therapy although is not approved for PrEP.

Emtriva is a component of single-tablet regimens (see STRs section) Atripla, Complera, Genvoya, Stribild, Biktarvy and in combination with darunavir, cobicistat and tenofovir alafenamide for a drug currently awaiting FDA approval.

Emtriva is also effective against Hepatitis B although should not be used for treatment of Hepatitis B alone only in combination of HIV treatment.

DHHS Status: Recommended in Combination as Initial Regimen for Most People with HIV

Manufacturer: Gilead Sciences (www.gilead.com) Viread (www.viread.com)

FDA approval date: October 26, 2001

Financial Assistance: https://www.gilead.com/responsibility/us-patient-access/us-advancing-access

Viread comes in 300mg tablets. Standard dose is one tablet, once a day. It can be taken with or without food.

Review:Viread is considered “Recommended in combination as initial regimen for most people with HIV” in the current DHHS guidelines. It is a very popular drug and, as with Emtriva, is used as a combination in Truvada, Atripla, Complera, and Stribild. The combination with Emtriva in Truvada was approved by the FDA in July of 2012 for HIV prevention Pre-exposure Prophylaxis also known as PrEP in HIV negative individuals. For more information on PrEP, go online to www.truvadapreprems.com.

Viread is also approved by the FDA for Hepatitis B therapy.

Viread is technically a Nucleotide Reverse Transcriptase Inhibitor but it is similar to the Nucleoside Reverse Transcriptase Inhibitors so we have grouped it in (as most do) here.

Gilead Sciences has been replacing Viread (tenofovir disoproxil fumarate- or-TDF) with Tenofovir Alafenamide Fumarate-or-TAF which is shown to have lower rates of kidney and bone disease when compared to Viread. Genvoya was the first single-tablet regimen to contain TAF rather than TDF, and Odefsey is the second (see both in STR section). The third is a reformulation of Truvada that is Descovy (see previous). TAF is also present in the newest STR, Biktarvy and is awaiting FDA approval in combination with darunavir, cobicistat and emtricitabine.

DHHS Status:Recommended in Combination as Initial Regimen for Most People with HIV *In combination with dolutegravir as Triumeq*

Manufacturer: ViiV Healthcare (www.viivhealthcare.com)
Epzicom (www.epzicom.com)

FDA approval date: August 2, 2004

Financial Assistance: https://www.epzicom.com/hcp/patient- assistance.html

Each Epzicom tablet contains 300mg of Epivir (lamivudine) and 600mg of Ziagen (abacavir). The standard dose is one tablet a day.

Review: Epzicom is a combination drug, which like Truvada, allows you to take two-thirds of your three-drug regimen in one pill and is a Nucleoside Reverse Transcriptase Inhibitor or “Nuke.”

The current DHHS guidelines list Epzicom as “Recommended in combination as initial regimen for most people with HIV,” when in combination with dolutegravir as Triumeq otherwise the DHHS recommends Truvada or Descovy as a NRTI backbone because of concerns of cardiovascular risks in studies and because in another study persons did not do as well when they started at a higher viral load – greater than 100,000 copies/mL. Epzicom is a good alternative to Truvada currently however, because it is very useful to persons who have kidney problems.

Epzicom was given FDA approval on August 22, 2014 in combination with Tivicay (dolutegravir) - which is an Integrase Inhibitor approved by the FDA in August of 2013 as a stand alone drug - as the single tablet regimen drug, Triumeq.

Before using Epzicom, there is a test that must be taken that predicts who may be allergic to Ziagen. The test is called HLA-B*5701. Epzicom is considered a good drug for those who test negative for HLA-B*5701. Those who test positive for HLA-B*5701 should not take Epzicom.

DHHS Status: Recommended in Combination as Initial Regimen for Most People with HIV *In combination with dolutegravir and abacavir as Triumeq*

Manufacturer: ViiV Healthcare (www.viivhealthcare.com)
Epivir (www.viivhealthcare.com)

FDA approval date: November 17, 1995

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

Recommended dose is one 300mg tablet once a day or one 150mg tablet twice a day. You can take it without regard to meals.

Review: Epivir is an older yet still important part of combination therapy today although it is not considered to be quite as good as its newer rivals Emtriva and Viread. It is very tolerable. Epivir is one of the ingredients in Combivir, Trizivir and Epzicom. Epivir has been combined with Ziagen and Tivicay in the single tablet regimen Triumeq that was approved in August of 2014 year and is a “Recommended Initial Regimen for Most People with HIV “ therapy in the current DHHS guidelines. Epivir is available in generic form and also approved by the FDA for Hepatitis B therapy.

DHHS Status: Recommended in Combination as Initial Regimen for Most People with HIV *In combination with dolutegravir and lamivudine as Triumeq*

Manufacturer: ViiV Healthcare (www.viivhealthcare.com)
Ziagen (www.viivhealthcare.com)

FDA approval date: December 17, 1988

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

Comes in 300mg tablets and 20mg/mL oral solution. Recommended dose is 300mg (one tablet) twice a day. You can take it without regard to meals.

Review: Ziagen carries with it the risk of hypersensitivity reaction, which occurs in about 5% - 8% of people. This can include fever, rash, fatigue, nausea, vomiting, diarrhea and abdominal pain. A simple blood test, however, HLA-B*5701 can screen for this potential to see if you may or may not be at risk. Ziagen is one of the ingredients in both Trizivir and Epzicom. Ziagen is also an ingredient (along with Epivir and Tivicay) in the single tablet regimen drug Triumeq, that was approved by the FDA in August of 2014 and is considered “Recommended Initial Regimen for Most People with HIV “ in the current DHHS guidelines.

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