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Investigational
Investigational

This section deals with four new investigational drugs that have yet to be fully approved. Note: These drugs have not been approved for use by the FDA and do not have specific brand names at this time.


ELVITEGRAVIR

Manufacturer: Gilead Sciences (www.gilead.com)
FDA approval date: TBD
Drug category: Integrase Inhibitor

In phase 3 trials one 150mg or one 85mg tablet once-a-day boosted with Norvir or cobicistat.

REVIEW:

Elvitegravir will be a new entry in the integrase inhibitor market which currently only has Isentress as approved in this class of HIV drug. Elvitegravir is also the integrase inhibitor included in the investigational “Quad.” Elvitegravir can be used by treatment-experienced patients however, if there is a resistance to Isentress, patients are likely to have a resistance to elvitegravir as well.


DOLUTEGRAVIR

Manufacturer: ViiV Healthcare (www.viivhealthcare.com) and Shionogi (www.shionogi-inc.com)
FDA approval date: TBD
Drug category: Integrase Inhibitor

In phase 3 trials one 50mg tablet, once-a-day.

REVIEW:

Dolutegravir is still in clinical trial stage but is available through expanded access programs. Unlike the other integrase inhibitor, elvitegravir, soon to be released in competition with Isentress, dolutegravir doesn’t require a booster, which is great news. Dolutegravir is also considered a “second generation” drug, and means that it can work for those who have developed a resistance to Isentress and elvitegravir.


COBICISTAT

Manuafacturer: Gilead Sciences (www.gilead.com)
FDA approval date: TBD
Drug category: Pharmacokinetic (PK) Enhancer

Cobicistat dosing is to be determined.

REVIEW:

Cobicistat is a drug used to boost the levels of other medications and is not in and of itself an HIV medication. It is an alternative to Norvir and while still having some of the same side effects as Norvir, it is scheduled to be co-formulated into one-pill dosing with Prezista and Reyataz so that will be an advantage over Norvir.


“QUAD ” (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir)

Manufacturer: Gilead Sciences (www.gilead.com)
FDA approval date: TBD
Drug category: Combination Drug

The standard dose for the “Quad” in phase 3 trials is one tablet (150mg elvitegravir/ 150mg cobicistat/ 200mg emtricitabine/ 300mg tenofovir) once daily.

REVIEW:

The “Quad” will be the third single-tablet HIV regimen and should be approved later this year. The fourth component in the “Quad,” which distinguishes it from both Atripla and Complera, is an integrase inhibitor. The integrase inhibitor included in the “Quad” is elvitegravir. Currently, the only integrase inhibitor on the market is Isentress.


 

Combination Drugs

Protease Inhibitors

Nucleoside Reverse Transcriptase Inhibitors

Non-Nucleoside Reverse Transcriptase Inhibitors

Fusion Inhibitor

Entry Inhibitor

Integrase Inhibitor

 



 

 

 

 

 

 

 

 

 



Copyright 2013, 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!