Individuals recently infected with hepatitis C virus (HCV), including those coinfected with HIV, stand an excellent chance of a cure from eight weeks of treatment with Merck’s Zepatier (grazoprevir/elbasvir).
Anne Boerekamps, MD, an infectious disease specialist at Erasmus University Medical Center in Rotterdam, Netherlands, presented findings from a prospective single-arm, open-label multicenter Phase IIb Dutch Acute HCV trial of eight weeks of Zepatier at the 2018 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.
Fifteen hospitals referred 146 people recently infected with hep C to nine study centers in the Netherlands and Belgium. Ultimately, 80 of these individuals participated in the study.
To be included in the trial, participants needed to start treatment within six months of the estimated date of infection, have genotype 1 or 4 of hep C and not have cirrhosis. If they were HIV positive, they needed to have a viral load of 500 or above if they were not on antiretrovirals (ARVs) for that virus; if they were on ARVs, they needed to have a viral load of 400 or below.
The participants were all men who have sex with men (MSM) who likely had contracted the virus sexually and had an average age of 47. Sixty-four percent had genotype 1a and 36 percent had genotype 4. Seventy-six percent had contracted hep C for the first time, 19 percent for the second time, 3 percent for the third time and 1 percent each for the fourth and the fifth time.
Ninety-one percent of the participants were coinfected with HIV. They had a median CD4 count of 605. All of them were on ARVs, and 98 percent had a fully suppressed viral load.
By the time of the study’s analysis for the conference presentation, 72 participants had made it to the end of eight weeks of Zepatier treatment; for 63 of them, 12 weeks or more had passed since the end of their treatment. Fifty-nine of these individuals achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure).
Of the four people who did not achieve an SVR12, three had been reinfected with hep C and one had experienced a viral relapse. Because the study did not count reinfection as a treatment failure, this meant that Zepatier cured 98 percent (62 of 63) of the individuals. If the study had counted reinfection as treatment failure, then the cure rate would have been 94 percent (59 of 63).
There were no serious adverse health events among the participants judged to be related to Zepatier treatment.
The most common adverse events seen during the study included the common cold (22 percent), gastrointestinal complaints (24 percent), sexually transmitted infections (24 percent), fatigue (17 percent), insomnia (8 percent), psychological diagnoses (8 percent) and vertigo (6 percent).
To read the conference abstract, click here.