A new HIV drug has fewer side effects and will bolster the arsenal against the disease, a University of Nebraska Medical Center physician and his fellow researchers say.
A New England Journal of Medicine article published in November indicates that the new drug generally performs better than Atripla, which for several years has been the go-to drug for HIV.
Although medications to fight the virus have been available for years, regimens sometimes required patients to take many pills each day and endure harsh side effects such as nausea and stomach pain. But scientists have reduced many HIV patients' daily pill intake to one or two, diminished the side effects and minimized the amount of virus in the patient.
HIV patients who adhere to their treatment regimens now can enjoy a life expectancy similar those who don't have the virus, a UNMC physician said. Adherence also diminishes the likelihood that they will spread the virus.
The new drug, dolutegravir, was approved by the Food and Drug Administration in August. The drug's brand name is Tivicay.
“What it means is we're increasing our arsenal of drugs. I know it works well,” said Dr. Uriel Sandkovsky, a UNMC assistant professor of medicine and infectious disease who is one of 14 authors of the New England Journal article.
In the study, dolutegravir, combined with two other drugs, had fewer side effects than Atripla and did as good a job of lowering the amount of the virus in the bloodstream.
Side effects have been a major concern regarding HIV medications. Atripla's side effects typically diminish or go away with time, Sandkovsky and others said. But they can include weariness, vivid dreams, rashes and dizziness.
A 52-year-old Lincoln man who was diagnosed with HIV three years ago participated in the clinical trial for dolutegravir (pronounced DOUGH-lou-TEG-rah-veer).
The man, who asked that his name not be used because knowledge of his health status and sexual orientation could jeopardize his job, said he had heard of terrible side effects of HIV medications.
“I had no side effects that I noticed or that I could attribute to the drug,” the man said of dolutegravir. “I didn't have any problem with it.”
More than 830 patients participated in the clinical trial, which included participants in North America, Europe and Australia. UNMC had about 10 patients in the project. The trial, comparing Atripla to a combination of drugs that included dolutegravir, started in 2011 and will officially end next spring.
The study was supported by Viiv Healthcare, a group of pharmaceutical companies formed to work on HIV medications. Viiv researchers created dolutegravir.
HIV is a virus spread to others through body fluids. The virus can break down patients' immune systems and render them unable to fight diseases. At that stage, HIV becomes AIDS. Some 50,000 Americans contract HIV each year. Nebraska and Iowa health departments estimate their HIV populations at 2,300 and 2,782 respectively. The majority of those with HIV are men who have sex with other men.
Both Atripla and the dolutegravir combination generally lowered the viral load to a level at which HIV would “almost never” be transmitted to a partner, Sandkovsky said. But dolutegravir caused fewer patients to suffer side effects. Dolutegravir caused more to suffer insomnia, but it was “typically mild in intensity,” the article said.
“This one is fabulous,” Dr. Susan Swindells, medical director of the UNMC HIV clinic, said of the new drug. “The side-effect profile is really clean and the potency is terrific.”
Cost is a challenge for patients taking either Atripla or the dolutegravir therapy. Sandkovsky said Atripla can cost the uninsured more than $2,000 a month. Dolutegravir, in combination with the other drugs in that regimen, costs the uninsured well over $2,000 monthly.
Pharmaceutical firms generally have assistance programs for those who are uninsured or who have high out-of-pocket costs.
Sandkovsky said he has begun prescribing the new drug for HIV patients. The Lincoln patient said he worries about how much his insurance will contribute toward the high price of the drug once the trial is over. Sandkovsky said he will see to it that his patient gets the medication he needs.