Researchers enrolled 29 participants with HCV genotype 3 and treated them with eight weeks of ABT-493 + ABT-530. Twenty-eight out of 29 participants completed the study and 28 of the 29 (97%) were cured. The remaining person quit the study after six weeks because of intolerance for study visits and drawing of blood samples.
Study Details
Researchers enrolled 29 participants with the following average profile at the start of the study:
age -- 47 years
52% men, 48% women
body mass index (BMI, a relative indicator of fatness) -- 26
viral load -- 6.5 logs
86% of participants had genotype 3a (the subtype of the remaining participants was not available)
almost 70% of participants had a minimal degree of liver injury
Overall, 13 participants had HCV that was resistant to inhibitors of NS5A or NS3 and, in one case, both classes of drugs.
Results
Twelve weeks after cessation of therapy, 97% (28 out of 29) of participants were cured.
Common adverse effects were as follows:
headache -- 17%
unexpected tiredness or lack of energy -- 10%
diarrhea -- 10%
sleep problems -- 10%
Abnormal Lab Test Results
Once participants entered the study it was rare for them to develop abnormal lab test results that were graded worse than mild. One participant had moderately elevated levels of the waste product bilirubin.
Participants who entered the study with already elevated levels of liver enzymes had them normalize during the study.
Key Points
Eight consecutive weeks of therapy with ABT-493 + ABT-530 was able to cure 28 out of 29 people (97%) with HCV genotype 3 infection, none of whom had cirrhosis.
Treatment was effective despite the presence of strains of HCV that could resist therapy.
The combination was well tolerated.
Reference
Muir A, Strasser S, Wang S, et al. High SVR rates with ABT-493 + ABT-530 co-administered for 8 weeks in non-cirrhotic patients with genotype 3 infection. The International Liver Congress, 13-17 April 2016, Barcelona. Abstract PS098.