Two new all-oral regimens improve hepatitis C treatment
January 06 2015 4:01 AM EST
May 26 2023 2:13 PM EST
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People with hepatitis C, a common coinfection with HIV, have just gotten more medication choices, and unlike earlier treatments, the new ones don’t need to be accompanied by interferon injections. They build on the success of two drugs first approved in 2013, Sovaldi and Olysio.
In the fall the Food and Drug Administration approved two all-oral treatments. Harvoni, from Gilead Sciences, combines its highly successful Sovaldi medication (generic name sofosbuvir) with a drug called ledipasvir. The tablet is to be taken once daily for a duration of eight, 12, or 24 weeks, depending on prior treatment history. In three Phase III studies, it achieved cure rates of 94 to 99 percent, according to Gilead.
The FDA also gave the green light to physicians to prescribe Janssen Therapeutics’ hep C drug Olysio along with Sovaldi. Some doctors have already been prescribing them together, but many were reluctant to do so without the FDA’s blessing. The latest action clears up any uncertainty. The two drugs are taken for either 12 or 24 weeks, depending on the patient. Studies showed cure rates of 93 to 97 percent.
In addition to allowing patients to skip the interferon injections, which can cause flu-like symptoms, the new regimens don’t require the use of another antiviral drug, ribivarin.
Experts estimate that one quarter of all people with HIV have the hepatitis C virus as well, and one half of all HIV-infected injection-drug users. If left untreated, the hep C virus can result in life-threatening complications such as cirrhosis and cancer.