Health Highlights: Nov. 5, 2015
New HIV Therapy Approved by FDA Prescription Painkillers, Heroin the Top Drug Threats in U.S. Senate Committee to Investigate Huge Drug Price Hikes
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
New HIV Therapy Approved by FDA
A new treatment for HIV has been approved by the U.S. Food and Drug Administration.
Genvoya -- a tablet containing the drugs elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide -- can be used to treat HIV-1 infection in adults and children 12 and older weighing at least 77 pounds.
The approval is based on four clinical trials that included a total of 3,171 patients. They showed Genvoya was effective in reducing viral loads and comparable to other treatments, the FDA said.
Genvoya -- made by California-based Gilead Sciences Inc. -- contains a new form of tenofovir not previously approved by the FDA. This new form of tenofovir places lower amounts of drug in the bloodstream, but higher amounts within cells where HIV-1 replicates.
"Today's approval of a fixed dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
The most common side effect associated with Genvoya is nausea. The product carries a Boxed Warning about the possible risk of a buildup of lactic acid in the blood and severe liver problems, both of which can be fatal.
The warning also states that Genvoya is not approved to treat chronic hepatitis B infection.
Prescription Painkillers, Heroin the Top Drug Threats in U.S.
Prescription painkillers and heroin are among the major drug threats in the United States, the federal government says.
Of the more than 46,000 drug overdoses in 2013, about half were from prescription drugs and more than 8,000 from heroin, according to a Drug Enforcement Administration drug threat assessment released Wednesday, the Associated Press reported.
Heroin is most popular among drug users in the Northeast and Midwest, but the drug has become more available nationwide and its use increased about 50 percent between 2013 and 2014, the DEA said.
Between 2010 and 2014, seizures of heroin rose from 2,761 kilos to 5,013 kilos, the AP reported.
Methamphetamine is another major drug threat, according to the DEA.
One positive note is the falling availability and use of cocaine, said Chuck Rosenberg, the DEA's acting administrator, the AP reported.
Senate Committee to Investigate Huge Drug Price Hikes
Drug pricing by four companies will be investigated by the U.S. Senate's Special Committee on Aging.
The four companies -- Valeant Pharmaceuticals International Inc., Turing Pharmaceuticals AG, Retrophin Inc. and Rodelis Therapeutics -- were sent letters asking why they introduced huge price increases for drugs, Bloomberg News reported.
The committee is particularly interested in why Turing boosted the cost of the anti-infection drug Daraprim from $13.50 to $750 a tablet.
A hearing on the issue is scheduled for Dec. 9. The use of subpoenas if the drug companies don't cooperate is supported by panel leader Senator Susan Collins of Maine, according to a committee spokesman, Bloomberg reported.