AbbVie’s so-called “3D” regimen plus ribavirin cured all people with genotype 4 of hepatitis C virus (HCV) in a recent trial, plus 91 percent of those with genotype 4 treated without ribavirin, reports. Researchers conducted a Phase IIb study, called PEARL-I, in which 42 treatment-naive and 49 treatment-experienced people with genotype 4 of hep C were treated with 3D plus ribavirin for 12 weeks. In addition, 44 treatment-naive people with genotype 4 were treated only with 3D, also for 12 weeks. Results were presented at the Annual Meeting of the American Association for the Study of Liver Diseases in Boston.

“As many as 34 million people around the world are living with genotype 4 chronic hepatitis C, a population that is common in the Middle East and Africa, where it accounts for more than 80 percent of all hepatitis C cases,” Barry Bernstein, MD, vice president of infectious disease development at AbbVie, said in a press release. “The data from PEARL-I represent another important step forward in realizing our commitment to advancing scientific knowledge in hepatitis C with the ultimate goal of providing treatment options to as many patients as possible.”

The 3D regimen consists of a coformulated, once-daily pill of the protease inhibitor paritaprevir (ABT-450), the NS5A inhibitor ombitasvir (ABT-267) and Norvir (ritonavir), which is taken with the twice-daily non-nucleoside polymerase inhibitor dasabuvir (ABT-333).

100 percent (91 out of 91 participants) of those who took ribavirin achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), compared with 91 percent (40/44) of participants who did not take ribavirin.

No one in the trial discontinued treatment because of adverse side effects. The most common side effects, reported in more that 15 percent of any group of the study, were headache (29 to 33 percent), weakness (24 to 33 percent), fatigue (7 to 18 percent), nausea (9 to 17 percent) and insomnia (5 to 16 percent).

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