A fixed-dose combination of ledipasvir + sofosbuvir (sold as Harvoni) has been licensed in Canada, the European Union and the U.S. for the treatment of HCV genotype 1. This single-tablet regimen contains:
Harvoni is meant to be taken once daily, with or without food.
In a trial called Sirius, researchers enrolled participants with the following clinical features:
Participants were randomly assigned to one of the following interventions:
As is standard in HCV clinical trials in the current era, the dose of ribavirin is based on a person's weight. People who weigh less than 75 kg took 1,000 mg/day and people who weighed 75 kg or more took 1,200 mg/day.
Doctors assessed the health of participants' livers in one of the following ways:
The average profile of participants was as follows:
The proportion of participants who achieved an SVR12 was distributed as follows:
Overall, regardless of whether or not ribavirin was used, researchers found significant improvements among participants who achieved an SVR12 when they reviewed the following laboratory tests of blood samples:
Relatively high rates of potential side effects were reported by participants who received the following:
Note that participants tend to report many possible side effects and complications in clinical trials. Collectively, drug side effects and complications are called "adverse events." These need to be investigated by researchers to determine if they were indeed drug side effects or due instead to the disease process caused by HCV (or in some cases HIV) or something else.
In Sirius, after investigation researchers attributed "serious" side effects as follows:
Less serious side effects were distributed as follows:
Cases of anemia were uncommon and only occurred in one person taking placebo and in three people taking ledipasvir + sofosbuvir + ribavirin.
Two people left the study prematurely in the following regimens:
The following complications and/or side effects were of mild-to-moderate intensity:
Difficulty falling asleep
Bone and/or joint pain
In participants whose prior interferon-based regimens failed and who had cirrhosis, 24 weeks of ledipasvir + sofosbuvir + placebo or 12 weeks of ledipasvir + sofosbuvir + ribavirin resulted in about 97% of participants achieving an SVR12.
Only two side effects -- headache and fatigue -- were significantly more common among ledipasvir + sofosbuvir users than among placebo users.
Most side effects were of mild-to-moderate intensity.
Bourlière M, Bronowicki J, de Ledinghen V, et al. Ledipasvir/sofosbuvir fixed-dose combination is safe and efficacious in cirrhotic patients who have previously failed protease-inhibitor-based triple therapy. In: Program and abstracts of The Liver Meeting, 7-11 November 2014. Abstract LB-6.
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