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Assessment of factors affecting response of direct-acting antivirals in chronic hepatitis C patients
Nipun Jain1, Ravinder Garg1, Gagan Preet Singh2, Sarabjot Kaur1, Sumit Pal Singh Chawla1, Preeti Padda3
1 Department of Medicine, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India
2 Department of Community Medicine, Guru Gobind Singh Medical College and Hospital, Faridkot, India
3 Department of Community Medicine, Government Medical College, Amritsar, Punjab, India
Correspondence Address:
Sarabjot Kaur,
Department of Medicine, Guru Gobind Singh Medical College and Hospital, Sadiq Road, Faridkot - 151 203, Punjab
India
 Source of Support: None, Conflict of Interest: None DOI: 10.4103/aam.aam_183_22
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Background: Hepatitis C virus (HCV) is a universally prevalent pathogen and a major cause of liver-related morbidity and mortality worldwide. The evolution of antiviral therapy for HCV has rapidly progressed from interferon (IFN)-based therapies to IFN-free combinations of direct-acting antivirals (DAAs). Aims: This study aims to assess the response of DAAs in chronic hepatitis C (CHC) patients and to study the various factors affecting the response of DAAs in CHC. Settings and Design: This longitudinal observational study spanning over a year was conducted in the Medicine department of a tertiary care teaching hospital. Materials and Methods: The study was conducted on 400 adult CHC patients, diagnosed by a positive anti-HCV antibody test and a detectable viral load (HCV RNA) by real time polymerase chain reaction (RT-PCR), registered for treatment with DAAs. The first 400 patients satisfying the eligibility criteria were enrolled by non-probability consecutive sampling. All the participants were treated as per the National Viral Hepatitis Control Programme (NVHCP) guidelines. Repeat HCV viral load was done at or after 12 weeks of completion of anti-viral therapy to ascertain sustained virological response (SVR). Various factors which might predict treatment response were analyzed. Statistical Analysis Used: The continuous variables were expressed as mean and standard deviation, while the categorical variables were summarized as frequencies and percentages. The Student's independent t-test was employed for the comparison of continuous variables. The Chi-square or Fisher's exact test, whichever is appropriate, was employed for the comparison of categorical variables. Multivariate Logistic Regression was used to identify the independent predictors of treatment nonresponse. A P < 0.05 was considered statistically significant. Results: The mean age of the subjects was 42.3 ± 15.23 years with a male-to-female ratio of 1.96:1. Most of the patients (80.5%) were non-cirrhotic; among 19.5% cirrhotic, 13% were compensated while 6.5% were decompensated cirrhotic. The overall SVR done at or after 12 weeks of completion of treatment was 88.75%. Age, gender distribution, occupation, socioeconomic status, educational status, body mass index, treatment regimen, duration of treatment, and baseline viral load did not alter the treatment response. Among comorbidities, only diabetes mellitus (DM) and human immunodeficiency virus (HIV) co-infection adversely affected the treatment response (P = 0.009 and P < 0.001, respectively). Intravenous (IV) drug abuse was significantly associated with treatment failure (P < 0.001). The presence of liver cirrhosis (P < 0.001), thrombocytopenia (P < 0.001), elevated transaminases (alanine transaminase: P = 0.021, aspartate transaminase: P < 0.001), and previous treatment experience (P = 0.038) were other significant predictors of treatment failure. Conclusions: DAAs are highly efficacious drugs in the treatment of CHC with a high rate of treatment response. Significant predictors of CHC treatment failure included comorbidities especially DM and HIV co-infection, IV drug abuse, presence of liver cirrhosis, thrombocytopenia, elevated transaminases, and previous treatment experience. However, independent predictors of treatment nonresponse observed in this study were thrombocytopenia, IV drug abuse, and liver cirrhosis.
Résumé
Contexte: Le virus de l'hépatite C (VHC) est un agent pathogène universellement répandu et une cause majeure de morbidité et de mortalité liées au foie dans le monde. L'évolution de la thérapie antivirale pour le VHC a rapidement progressé des thérapies à base d'interféron (IFN) à des combinaisons sans IFN de médicaments à action directe antiviraux (AAD). Objectifs: Cette étude vise à évaluer la réponse des AAD chez les patients atteints d'hépatite C chronique (HCC) et à étudier les différents facteurs affectant la réponse des AAD dans les CHC. Cadres et conception : Cette étude observationnelle longitudinale s'étalant sur un an a été menée dans le département de médecine d'un hôpital universitaire de soins tertiaires. Matériels et méthodes: L'étude a été menée sur 400 patients adultes atteints d'HCC, diagnostiqués par un test d'anticorps anti-VHC positif et une charge virale détectable (ARN du VHC) par réaction en chaîne par polymérase en temps réel, inscrit pour le traitement par DAA. Les 400 premiers patients répondant aux critères d'éligibilité ont été enrôlés par échantillonnage consécutif non probabiliste. Tous les participants étaient traités conformément aux directives du programme national de contrôle de l'hépatite virale. La charge virale répétée du VHC a été effectuée à ou après 12 semaines d'achèvement traitement antiviral pour déterminer la réponse virologique soutenue (RVS). Divers facteurs susceptibles de prédire la réponse au traitement ont été analysés. Analyse statistique utilisée: les variables continues ont été exprimées sous forme de moyenne et d'écart-type, tandis que les variables catégorielles ont été résumés sous forme de fréquences et de pourcentages. Le test t indépendant de Student a été utilisé pour la comparaison des variables continues. Le chi carré ou Le test exact de Fisher, selon le cas, a été utilisé pour la comparaison des variables catégorielles. La régression logistique multivariée a été utilisée identifier les prédicteurs indépendants de la non-réponse au traitement. A P < 0.05 était considéré comme statistiquement significatif. Résultats: L'âge moyen des sujets était de 42.3 ± 15.23 ans avec un ratio hommes-femmes de 1.96:1. La plupart des patients (80.5%) |
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