Clinical management of prescribed co-medication in patients treated with OBV/PTV/r ± DSV ± RBV – Data from the German observational study LIFE-C

Question:

Clinical trials and real-life data often focus on the safety and efficacy/effectiveness of ombitasvir/paritaprevir/r ± dasabuvir ± ribavirin (RBV). We conducted a large non-interventional observational study (LIFE-C) to assess effectiveness and safety, but also to learn more about key patient characteristics (i.e., comorbidities and co-medication) and the clinical management of prescribed co-medication in patients treated with ombitasvir/paritaprevir/r ± dasabuvir ± RBV in Germany.

Methods:

All adult patients treated with ombitasvir/paritaprevir/r ± dasabuvir ± RBV according to the local label were eligible for the study. Patients” visits were scheduled at the physician's discretion and according to clinical practice. Study documentation was possible at baseline, during and at the end of the treatment, and at post-treatment week 4, 12, and 24. Comorbidities and co-medication could be documented at baseline. Adaptations in co-medication, especially initiating or stopping of co-medication, could be recorded in a tracked mode during the entire study period.

Results:

The study was conducted between December 2015 and December 2016. Altogether, 472 patients were enrolled. On 2017, August 1st, sufficient data for safety, and effectiveness analysis were available for 252 and 235 patients, respectively. At baseline (n = 252), genotype (GT) 1b was most prevalent (61.9%), followed by GT1a (27.8%) and GT4 (10.3%). Regarding comorbidities, 71.0% of the baseline patients had at least one comorbidity. The most common comorbidities were cardiovascular diseases in 27.4% of patients, followed by psychoactive substance dependencies (13.1%), and psychiatric disorders (11.1%). Consequently, 61.9% of patients took at least one co-medication during treatment: 11.1% beta blocking agents, 11.1% drugs in addictive disorders, and 10.7% drugs for peptic ulcer and gastro-oesophageal reflux disease. Of all drugs taken at the start of treatment, 95.4% were continued during the study period. Overall SVR12 was 97.4% (n = 229/235) with fatigue (7.5%), pruritus (4.0%) and rash (3.2%) as the most common adverse events. SVR12-rates in specific populations were as follows: cirrhotics 94.4% (n = 17/18), elderly > 70 years 97.4 (n = 37/38), and patients on opioid substitution 91.7% (n = 22/24).

Conclusions:

Ombitasvir/paritaprevir/r ± dasabuvir ± RBV is highly effective and well tolerated in real-life conditions. More than two third of patients had at least one comorbidity and, consequently, took co-medication. However, most of the drugs could be continued during treatment. Data for all patients with sufficient follow up data (i.e., SVR12) will be presented at the congress.