Retrospective analysis of hepatitis C infected patients treated through an integrated care model

Abstract

AIMTo determine if our health system’s integrated model reflects sustained virologic response (SVR) outcomes similar to those in clinical trial data, maximizes adherence, and averts drug interactions.METHODSSubjects with chronic hepatitis C had their medical records reviewed from November 1st, 2014 through March 1st, 2016. Patients eligible for treatment were entered into an integrated care model therapy algorithm. The primary outcome was SVR12 based on intention to treat (ITT) analysis. Inclusion criteria consisted of both treatment naïve and experienced patients over the age of 18 who were at least twelve weeks post-therapy completion with any genotype (GT) or METAVIR score. Secondary outcomes included adherence, adverse events, and number of drug interaction interventions.RESULTSAt the time of analysis, 133 patients had reached twelve weeks post therapy with ITT. In the ITT analysis 70 patients were GT 1a, 26 GT 1b, 23 could not be differentiated between GT 1a or 1b, 8 GT 2, 4 GT 3, and 2 patients with multiple genotypes. The ITT treatment regimens consisted of 97 sofosbuvir (SOF)/ledipasvir (LDV), 8 SOF/LDV and ribavirin (RBV), 7 SOF and Simeprevir (SMV), 6 3D and RBV, 1 3D, 11 SOF and RBV, and 1 SOF, peg interferon alpha, and RBV. The overall SVR12 rate was 93% in the ITT analysis with a total of 6 patients relapsing. In patients with cirrhosis, 89% obtained SVR12. All 33 patients who were previous treatment failures achieved SVR12. Drug-drug interactions were identified in 56.4% of our patient population, 69 of which required interventions made by the pharmacist. The most common side effects were fatigue (41.4%), headache (28.6%), nausea (18.1%), and diarrhea (8.3%). No serious adverse effects were reported.CONCLUSIONDean Health System’s integrated care model successfully managed patients being treated for hepatitis C virus (HCV). The integrated care model demonstrates high SVR rates amongst patients with different levels of fibrosis, genotypes, and HCV treatment history.

Evaluation of pharmaceutical intervention in direct-acting antiviral agents for hepatitis C virus infected patients in an ambulatory setting: a retrospective analysis

“…The adherence rate was not influenced by the dosage form (either the combination tablets or the non-combination tablets). Some previous reports have indicated that the SVR12 rate is 88.2–95.3% in real-world settings [ 9 , 12 , 16 – 18 ], and 84.4–98.1% in phase 2–3 trials [ 15 , 19 – 21 ]. In this study, the SVR12 rate was 99.6% (Table 2 ), which is relatively higher than in the previous studies [ 9 , 12 , 16 – 18 ].…”

“…Some previous reports have indicated that the SVR12 rate is 88.2–95.3% in real-world settings [ 9 , 12 , 16 – 18 ], and 84.4–98.1% in phase 2–3 trials [ 15 , 19 – 21 ]. In this study, the SVR12 rate was 99.6% (Table 2 ), which is relatively higher than in the previous studies [ 9 , 12 , 16 – 18 ]. These results indicate that the pharmaceutical support provided by the ambulatory care pharmacy practice, including explanation of the importance of adherence and the management of adverse drug events, helped the achievement of favorable SVR rates, probably due to the enhancement of adherence.…”

“…Meanwhile, DAAs have some interactions with some drugs, caused by induction or inhibition of cytochrome P450 or pH changes in the stomach. The adherence of these agents can reflect the efficacy of DAA therapy [ 5 , 6 , 9 ]. Therefore, management of drug interactions and facilitating patient adherence to DAAs are important to achieve adequate therapeutic effects.…”

HCV Integrated Care: A Randomized Trial to Increase Treatment Initiation and SVR with Direct Acting Antivirals

“…Treatment initiation increased 2- to 3-fold and on-site patients receiving more services had higher odds of initiating treatment [ 16 ]. Another recent study used a multidisciplinary team focused on educating patients before antiviral treatment and facilitating medication adherence in an HMO setting [ 17 ]. The study lacked a comparison group but obtained SVR rates in an outpatient HMO setting similar to those found in highly controlled clinical trials.…”

Building a Hepatitis C Clinical Program: Strategies to Optimize Outcomes

“…Pharmacists may also contribute directly to therapy monitoring either in clinic or via telemedicine. Studies have demonstrated improved adherence in addition to preventing drug-drug interactions and medication errors with pharmacy involvement [ 50 – 53 ]. More than 50% of HCV patients treated in a multidisciplinary model consisting of an infectious diseases physician, HCV nurse, and specialty pharmacist were identified to have drug-drug interactions requiring interventions by a pharmacist [ 50 ].…”