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In the News: FDA Approves New Combination Pill for HIV Treatment

I always get excited when I hear about new treatments for chronic illnesses because we all know someone impacted by at least one. Chronic illnesses such as Cancer, Diabetes, HIV, Alcoholism, and Hepatitis C all rank high on the national health agenda for research, funding and allocation of treatment. Preventing and treating chronic illnesses are necessary to preserve the health of our nation.

Today the U.S. Food and Drug Administration issued a press release today approving the Gilead produced drug – Stribild for treatment of HIV infection. Stribild is  a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.

“Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs and is used to prolong the effect of elvitegravir. The combination of emtricitabine and tenofovir disoproxil fumarate, approved in 2004 and marketed as Truvada, blocks the action of another enzyme that HIV needs to replicate in a person’s body. Together, these drugs provide a complete treatment regimen for HIV infection.

Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “New combination HIV drugs like Stribild help simplify treatment regimens.” [FDA, 2012]

The common HIV multi-pill treatment process has now been simplified and when you take a look at the long list of HIV medications that an HIV positive person must take, this is nothing short of a miracle. Anti-HIV Medicines

The main drug treatment for people with HIV is Highly Active Antiretroviral Therapy (HAART)which slows the growth of HIV in ones’ body. HAART is made up of different kinds of medicines: [FDA, 2012]

1. Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

2. Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)

3. Protease Inhibitors

4. Fusion Inhibitors

5. Integrase Inhibitors

6. Entry Inhibitors

7. Combination Drugs

The different types of medicines per category range anywhere from one drug to thirteen. For example, the “entry inhibitor” drug is Selzentry while the “Nucleoside Reverse Transcriptase Inhibitor drugs” are Emtriva, Epivir, Epzicom, Hivid, Retrovir, Truvada,Videx EC, Viread, Zerit, Ziagen.  That’s just for two of the different types of drugs needed to treat HIV. Everyone is different and depending on different factors (length of infection, progression of infection, sex, age, etc.) different types of medication and dosages are prescribed to combat HIV.

The safety and effectiveness of Stribild was evaluated in 1,408 adult patients not previously treated for HIV in two double-blind clinical trials. Results showed between 88 percent and 90 percent of patients treated with Stribild had an undetectable amount of HIV in their blood, compared with 84 percent treated with Atripla and 87 percent treated with Truvada plus atazanavir and ritonavir.

Although this new drug relieves HIV patients from the task of taking many pills it has some pretty severe side effects like fatal lactic acid build up or liver problems. Other Stribild side effects include nausea, diarrhea, kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system.

Read the full FDA press release here.



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