PARIS — Two real-world studies presented at the International Liver Congress 2018 confirmed the efficacy and safety of Mavyret in Italy and Germany even in the face of multiple comorbidities.
“The first real-world results from Italy and Germany demonstrate that [glecaprevir/pibrentasvir (GP), AbbVie] achieved high SVR12 rates in patients with HCV infection similar to rates observed in clinical trial,” Markus Cornberg, MD, Hannover Medical School, Hannover, Germany, said during a press conference. GP received approval in Europe in July 2017, so Cornberg noted this was the first real-world experience of GP to be presented.
In NAVIGATOR-II, Roberta D’Ambrosio, MD, and colleagues looked at 723 Italian patients with HCV treated with GP. Cornberg presented the retrospective, longitudinal study’s interim results.
At baseline, 639 patients received treatment for 8 weeks and 84 received treatment for 16 weeks, mainly due to advanced fibrosis. There was only one relapse in the 8-week treatment group and “excellent SVR rates” in both groups. In additional data, Cornberg showed one out of the 347 patients relapsed at week 4 post-treatment (99.7% SVR). Those results included 24 patients who were HIV-positive and eight who were in advanced chronic kidney disease, none of whom were the relapse patient.
“These [comorbidities] were excluded from the clinical trials, so it is important that we now have real-world data in those patients,” Cornberg said.
The German registry study is an ongoing non-interventional, multicenter, prospective registry study. Thomas Berg, MD, presented the results at the meeting. This group collected data from 638 patients at 104 sites in Germany between July 28, 2017, and February 9, 2018, where patients received treatment with GP. This interim report included 96 patients, 93 of whom achieved SVR and three of whom discontinued due to other causes.
Cornberg said both trials had low rates of adverse events and discontinuations due to treatment-related adverse events was around 1%.
With this first approved pangenotypic 8-week treatment, Cornberg reiterated that confirming the efficacy of this more simple treatment was necessary to achieve hepatitis eradication and only further necessitates more simplistic diagnostic testing.
“Diagnostic tests are really the problem,” Cornberg said, pointing to the low rates of diagnosis around 20% to 30% in many countries. “This is the key issue – to find the patients. Otherwise, we cannot treat them.” – by Katrina Altersitz
For more information:
Berg T, et al. GS-007. Presented at: International Liver Congress; Apr. 11-15, 2018; Paris, France.
D’Ambrosio R, et al. GS-013. Presented at: International Liver Congress; Apr. 11-15, 2018; Paris, France.
Disclosure: Cornberg reports he received honoraria for lectures and advisory board roles from AbbVie, Gilead and Merck Sharp & Dohme.
Editor’s note: This item has been updated with clarifications from the presenter.