Safety of new DAAs for chronic HCV infection in a real life experience: role of a surveillance network based on clinician and hospital pharmacist

Abstract

BackgroundDirect Antiviral Agents (DAAs) for HCV therapy represents a step ahead in the cure of chronic hepatitis C. Notwithstanding the promising results in several clinical trials, few data are available on adverse effects in real life settings.MethodsWe have evaluated 170 patients with persistent infection and on those eligible to treatment we have followed up them through a network managed by clinician and hospital pharmacist.ResultsAccording to our data we have found that 41% (32 out of 78) of enrolled patients experienced adverse reactions, of these 40% were in those under 65 years while 60% was in patients older than 65 years, SVR was achieved in 88% of the patients (including drop-out). We had 4 drop-out treatment due to major adverse reaction (heart and lung related).ConclusionEven if new antiviral drugs seem to be promising, according to SVR, they require careful follow-up, possibly managed by clinician and hospital pharmacist, to avoid unrecognized side effects which may affect adherence and the real impact of these drugs on chronically infected subjects.

Tolerability and effectiveness of generic direct‐acting antiviral drugs in eradication of hepatitis C genotype 4 among Egyptian patients

“…In addition, DAAs were shown to be very effective irrespective of patient race, sex and viral genotype, leaving only few barriers to treatment . Various DAAs have been approved as combinations for treatment of GT‐4 in Egypt from 2014 to 2018, including sofosbuvir (SOF), ledipasvir (LDV), simeprevir, daclatasvir (DAC), paritaprevir/ombitasvir/ritonavir (2D) with or without ribavirin (RBV) …”

“…3 Various DAAs have been approved as combinations for treatment of GT-4 in Egypt from 2014 to 2018, including sofosbuvir (SOF), ledipasvir (LDV), simeprevir, daclatasvir (DAC), paritaprevir/ombitasvir/ritonavir (2D) with or without ribavirin (RBV). 4 The safety of DAAs has been already assessed in some clinical trials, revealing that they are well tolerated with almost no discontinuation rate or life-threatening adverse events. However, future follow-up studies are still necessary due to short-term experience with these drugs.…”

Late HCC onset after DAAs therapy in patients with SVR: a type D ADR that requires a longer follow-up?

“…This is part of a large study enrolling 1022 consecutive HCV patients treated with IFN-free DAAs regimens in a group of hospitals and academic centres in southern Italy (Campania Region). Our preliminary findings showed an SVR in 241 out of 250 (97%) patients of which six had a late occurrence of HCC (2.3%)4 (Table 1). Specifically HCC developed in mean 18.5 months after the end of treatment as one or more nodules (2–3 cm in mean) with thrombosis of the right portal vein and an increase in alpha-fetoprotein 5 x u.n.v (n.v. <15 UI/mL) at time of diagnosis.…”

“…This kind of approach has been managed throughout the creation of a network involving clinicians and pharmacists to improve the follow-up of the patients under treatment in terms of real-life efficacy and safety. Previously we published data on early ADR4, however we have continued to follow up these patients throughout the pharmacist-clinician network for at least 36 months. In this regard, here we present our preliminary data on 250 patients who completed at least 66 weeks' follow-up, based on clinical, laboratory, pharmacological and expert ultrasonography every 3 months in our out-patients' clinic.…”

Pulmonary complications of antiviral drugs (Sofosbuvir and Daclatasvir) used in treatment of patients with chronic hepatitis C virus

“…However, these symptoms were mild, manageable and did not require discontinuation or modification of the sofosbuvir plus daclatasvir regimen. These symptoms were reported together or separately in multiple studies 9,10,11,12,13,14 , but other studies didn't report any respiratory adverse effects during the sofosbuvir plus daclatasvir regimens for HCV treatment, and they reported that sofosbuvir plus daclatasvir combination was well tolerated without serious adverse events 15,16,17 .…”