Five real-world studies presented at the International Liver Conferences detail care for patients with viral hepatitis or at risk of non-alcoholic steatosis hepatitis (NASH)
VIENNA, AUSTRIA / ACCESSWIRE / April 12, 2019 / Trio Health, a leading provider of retrospective observational data on real-world patients, today announced results from five studies presented at the International Liver Conference.
''Trio Health is committed to elevating industry understanding of real-world patterns of care, and the factors associated with treatment success for patients with Hepatitis C Virus (HCV),'' said Scott Milligan, PhD, Head of Analytics, Trio Health. ''These data clearly demonstrate that, despite progress toward an HCV cure, challenges persist in how patients access these critical therapies, and this understanding can help industry in its efforts to reach and treat as many patients as possible.''
Continued Milligan, ''The studies presented by Trio Health show that, in patients with Hepatitis B Virus (HBV), the balance between managing side effects while maintaining efficacy has been made easier with tenofovir alafenamide (TAF). However, these data also highlight the critical need for continued evaluation, to understand the long-term effects of this treatment in the care of HBV patients. Also revealed in these studies are challenges facing novel therapies in development for the treatment of NASH, related to adoption when invasive procedures are also required.''
THU-116- Effectiveness of the salvage therapy sofosbuvir-velpatasvir-voxilaprevir (SOF-VEL-VOX) in chronic hepatitis C: Clinical practice experience from the Trio Network. Lead Author: Bruce Bacon
Although virologic failure is rare with the highly effective direct-acting antivirals (DAAs) available to treat HCV, the salvage therapy sofosbuvir-velpatasvir-voxilaprevir (SOF/VEL/VOX) is approved for patients that previously failed an NS5A inhibitor for any genotype, or sofosbuvir without an NS5A inhibitor for GT1A or GT31. In this study (n=196), utilization was not solely restricted to prior treatment failures; 12% were treatment naïve. A high percentage had cirrhotic disease (42%) and 41% had hypertension. HCV cure was observed in 98% of patients who completed therapy.
THU-127: Clinical practice experience with pan-genotypic therapies glecaprevir-pibrentasvir (GLE-PIB) and sofosbuvir-velpatasvir (SOF-VEL) in the Trio Network. Lead Author: Michael Curry
Pan-genotypic therapies offer cure rates up to 95% and above for patients who complete therapy2,3. Though these therapies are approved for use across different patient subgroups, this study reported that in clinical practice, direct-acting antivirals (DAAs) were varied in use. In real-world populations that may be more difficult to treat - older age, cirrhosis, prior treatment failures - providers were more likely to use SOF-VEL relative to use of GLE-PIB. This study further found that virologic failure with GLE-PIB, while infrequent, was associated with cirrhosis and prior treatment experience.
THU-135- Real-world HCV treatment in HCV-HIV coinfected population: Data from the Trio Network. Lead Author: Rick Elion
DAAs have been highly effective in rapidly curing HCV infection in HIV-coinfected patients, however, in clinical practice many patients with HIV/HCV co-infection do not receive HCV treatment4. In a previous study from the Trio Network, access to DAA was limited to 44% of the HIV/HCV coinfected population predominantly due to a prescription never being written. In this follow up study of 1,452 patients, which examines a more recent period in which all current DAA treatments were available, access to care has remained at 44%, with the main barrier being lack of prescription. These analyses found an association between prescription and populations who were sicker, in that they had a higher comorbidity burden and more advanced liver fibrosis.
FRI-167- Effectiveness and safety with tenofovir alafenamide (TAF) for hepatitis B in US clinical practice. Lead Author: Michael CurryConcerns over long term use of specific nucleoside/nucleotide analogues in the treatment of HBV stem from potential effects on kidney function and bone density loss, among other issues. Tenofovir alafenamide (TAF) is an effective therapy that has an improved safety profile, particularly for bone loss and renal injury. In this study of 250 patients treated with TAF for HBV, data indicate improved viral suppression on TAF (from 93% to 99.6%), ALT normalization (from 71% to 86%), and eGFR (from 85.6 to 90.1 ml/min) after 6 months of TAF. Improvements in
eGFR were most evident in patients with eGFR <60 ml/min, in which mean eGFR increased 15.5% from 48.4 to 56.0 ml/min after 6 months of TAF.
SAT-310- Real-world evaluation of NASH in US clinical practice: Underutilization of liver biopsy and liver imaging. Lead Author: Michelle Lai
Nonalcoholic steatohepatitis (NASH) requires histologic diagnosis by liver biopsy and the new drug development for NASH requires primary histologic endpoints (NASH resolution or fibrosis improvement). Hepatology clinical care has moved away from liver biopsy to utilizing non-invasive markers for clinical decision making. In this study, Trio evaluated EMR data for 2.7 million patients to evaluate the use of liver biopsy and liver imaging in patients with clinical diagnosis of NASH or at risk for NASH. Of these patients, 6% met the predefined criteria of either NASH diagnosis (n=8,010) or at risk of NASH (n=167,560). Despite fulfilling NASH risk criteria, liver biopsy was obtained in only 1-5% of subjects. In contrast, imaging was performed in 10-45% of subjects.
About Trio Health
Trio Health's mission is to improve the quality of care in patient outcomes through coordinating the efforts of all patient care stakeholders. The Multi-Disease Platform (MDX) combines disparate data in real-time from physicians and pharmacies throughout the patient journey. The MDX platform provides unparalleled insight to drug manufacturers, physicians, pharmacies, and payers on the performance of real-world patients from a clinical, operational, and financial perspective. Trio Health's comprehensive insight brings a new understanding of the delivery, use, and outcomes of specialty drugs to optimize the care of real-world patients. Learn more at www.triohealth.com.
1 Epclusa [Prescribing Information]. Gilead Sciences, Inc. Foster City, California. June 2016.
2 Curry M, et al. 2017. Sofosbuvir/Velpatasvir in Genotype 2-6 HCV: Real World Experience from the Trio Network. Gastroenterology 152: S1061.
3 Curry M, et al. 2018. Preferences in Clinical Practice with Glecaprevir/Pibrentasvir (GLE‐PIB), Ledipasvir/Sofosbuvir (LDV‐SOF), and Sofosbuvir/Velpatasvir (SOF‐VEL); Data from the Trio Network. Hepatology 68: S678
4 Roberson J. et al. Comparison of the Hepatitis C Continua of Care Between Hepatitis C Virus/HIV Coinfected and Hepatitis C Virus Mono-Infected Patients in Two Treatment Eras During 2008-2015, AIDS Res Hum Retroviruses, 2018 Feb;34(2):148-155.
For Trio Health
SOURCE: Trio Health