C0505 - Change in Alanine Aminotransferase May Serve as an Alternative for Sustained Virologic Response (SVR) in Low and Middle Income Countries

Ameer Halim, MD¹, Justin Canakis, DO², Ameer Abutaleb, MD¹, Sita Kottilil, ³, Mrunal M. Kamat, ⁴, Samir Shah, MD, DM^5
1University of Maryland Medical Center, Baltimore, MD; ²George Washington University School of Medicine, Washington, DC; ³Yale University School of Medicine, New Haven, CT; ⁴Global Hospitals, Mumbai, Mumbai, Maharashtra, India; ⁵Global Hospitals Mumbai, Mumbai, Maharashtra, India

Introduction: Hepatitis C Virus (HCV) has a prevalence of 70 million cases worldwide. Confirmatory PCR testing to determine sustained virologic response (SVR) after antiviral treatment can be costly in low and middle income countries (LMIC). Our aim was to determine if change in ALT can act as a surrogate for SVR to reduce treatment costs at the population level.

Methods: We conducted a retrospective cohort study of 149 patients in Mumbai, India who had received treatment for Hepatitis C from 2015 to 2021. All patients had confirmed HCV by PCR testing and were treated with different regimens direct acting antivirals (DAA) approved by the FDA equivalent in India for 12 or 24 weeks. Patients were brought for follow up after 12 weeks where they had repeat PCR testing in addition to liver function testing.

Results: 149 patients were included in the study. 128 achieved SVR (86%) and 21(14%) did not. There were no significant differences in SVR across genotypes (p = 0.93), diabetes status (p = 0.77), hyperlipidemia (p = 0.54), thyroid disease (p = 0.29), or CKD (p = 2.0). History of hypertension was seen in 39% of patients who achieved SVR and 14% who did not (p = 0.03). In the SVR group, only 29% were previously exposed to direct acting antivirals (DAA) while 52% were previously exposed in the no SVR group (p = 0.04). Multivariable regression analysis of treatment experience vs SVR (OR 1.1 (0.41,2.9) showed that this was not truly significant. Patients with advanced liver disease had lower SVR rates (p = 0.04). Multivariable regression analysis also showed that this was not truly significant when comparing no cirrhosis vs decompensated cirrhosis and compensated vs decompensated cirrhosis against SVR (OR 2.8 (0.77,10) and 2.9 (0.89,9.1). The change in ALT between initiation and completion of therapy was significantly different based on SVR status (46.7 vs. 11.5, p < 0.01). Additionally, patients with change in ALT > 10 were more likely to achieve SVR (62.5 vs 33.3, p < 0.01). Stratifying patients based on absolute value of ALT after completion of treatment also showed significance; ALT value < 20 had a PPV of 97.7 for SVR.

Discussion: Change in ALT may be a surrogate for negative viral load for confirmation of SVR in LMIC. Additionally, ALT < 20 after completion of treatment may also be a surrogate marker for SVR. Further research is needed to determine if ALT change remains significant in adjusted analyses and across various demographic and clinical parameters.


Disclosures:


Ameer Halim, MD¹, Justin Canakis, DO², Ameer Abutaleb, MD¹, Sita Kottilil, ³, Mrunal M. Kamat, ⁴, Samir Shah, MD, DM⁵. C0505 - Change in Alanine Aminotransferase May Serve as an Alternative for Sustained Virologic Response (SVR) in Low and Middle Income Countries, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.