The U.S. Food and Drug Administration approved a new HIV medication that only needs to be taken once a day. The drug, called Stribild, is a combination of four different medicines and will be prescribed to people undergoing treatment for an HIV infection for the first time.
“Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” Dr. Edward Cox, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research, said in the agency statement. “New combination HIV drugs like Stribild help simplify treatment regimens.”
Stribild is a combination of two previously approved medicines and two new HIV combating compounds. One of the new medicines, Elvitegravir, interferes with the production of the enzyme HIV uses to multiply. The other new chemical, Cobicistate, helps the HIV drugs stay in the system longer to prolong the effects of Elvitegravir. Stribild also uses the two drugs that are used in Truvada, which is already on the market, that work together to block the enzyme HIV needs for replication.
The safety and effectiveness of Stribild was evaluated in 1,408 adult patients not previously treated for HIV in two double-blind clinical trials. Patients were randomly assigned to receive Stribild or Atripla, an HIV drug that contains Truvada and efavirenz, once daily in the first trial; and Stribild or Truvada plus atazanavir and ritonavir once daily in the second trial.
According to the clinical trials conducted by Gilead Sciences, the drug’s maker, Stribild has the equivalent effectiveness of Altripla (an HIV drug by Gilead that was approved in 2006) but avoids some of the associated psychiatric effects. In two trials, after 48 weeks of treatment about 88 to 90 percent of the test subjects had undetectable amounts of HIV in their blood.
Like other HIV medications, Stribild will come with a warning that a buildup of lactic acid in the blood could lead to severe, potentially fatal, liver problems. Other serious side effects observed in the clinical trials were related to kidney problems, decreased bone mineral density, weight changes and changes in the patient’s immune system. Giliead Science also placed a warning on the box stating that Stribild is not intended to treat people with chronic hepatitis B virus infection.
Gilead, which is based in Foster City, Calif., must conduct more research to further determine the drug’s safety in women and children, how resistance develops to Stribild and possible interactions with other drugs, the FDA said.
The approval of Stribild is the latest action in an eventful year of for HIV/AIDS treatment. Earlier this year, the FDA approved the first over-the-counter home HIV test, then there was the approval of a drug to treat pre-exposure to HIV, and the government announced new drugs being added to the President’s Emergency Plan for AIDS Relief which works to fight the spread of AIDS in developing nations.
According to the Guardian Express, Gilead is making efforts to keep the costs low for certain parties. The paper reports, “Gilead says it would provide discounts to state AIDS Drug Assistance Programs, and would also offer various programs to help privately insured patients obtain the drug. Gilead further added that it had also granted rights to certain companies in India to make generic versions of Stribild for distribution in poor countries.”
Truvada Dose for HIV Drug
Benefits of Truvada’s use as a pre exposure prophylactic with Professor Salim Abdool-Karim and a prerecorded telephone interview with Dr. Debbie Birnkrant from the FDA.
New HIV Drugs
The drug Truvada has been approved for HIV prevention by the Food and Drug Administration. The news brings hope to those in high risk categories, but there are also concerns that it could lead to a return of risky behaviors.
Rates of Injection Drug Users with HIV Drops
Elton John and “Cured” Patients at International Aids Conference
Free Birth Control Pills Starting Today Under New Health Law
Gonorrhea Antibiotics May Not Be So Effective in Treatment, According to CDC