Clinical Effectiveness and Pharmacokinetics of Dalbavancin in Treatment-Experienced Patients with Skin, Osteoarticular, or Vascular Infections.

Dalbavancin (DBV) is a lipoglycopeptide approved for the treatment of Gram-positive infections of the skin and skin-associated structures (ABSSSIs). Currently, its off-label use at different dosages for other infections deserves attention. This work aimed to study the clinical effectiveness and tolerability of DBV in outpatients with ABSSSIs, osteoarticular (OA), or other infections, treated with either one or two 1500 mg doses of dalbavancin, for different scheduled periods.

Enhanced recovery after gynecological surgery: comparison between intrathecal and intravenous morphine multimodal analgesia.

Background: The purpose of the present study was to compare the effectiveness of intrathecal injection of morphine, inserted in the protocols of multimodal analgesia, versus intravenous morphine in the control of postoperative pain and course in women undergoing gynecological surgery.

Methods: An observational, single-center, retrospective and case-controlled study was performed. Data were collected in a group of women (N.

Long-Term Pharmacokinetics of Dalbavancin in ABSSSI and Osteoarticular Settings: A Real-Life Outpatient Context.

Dalbavancin is a lipoglycopeptide approved for treatment of Gram-positive infections of skin and skin-associated structures (ABSSSI). Currently, off-label use at high dosages for osteoarticular infections deserves attention. This work aimed to study the long-term plasma pharmacokinetics of dalbavancin in outpatients with ABSSSI or osteoarticular infections, treated either with one or two 1500 mg doses of dalbavancin.

Serological and virological response in patients with hepatitis B virus genotype E treated with entecavir or tenofovir: a prospective study.

European clinical practice guidelines (EASL) on chronic hepatitis B (CHB) recently recognized the importance of migration flows in the changing hepatitis B virus (HBV) epidemiology in low-endemic European countries. The role of different genotypes in nucleos(t)ide analogue (NA) treatment is still unknown. In the case of genotype E, which is mainly circulating in West Africa, a quantitative decrease in the level of HBsAg (qHBsAg) during treatment with entecavir (ETV) predicts a longer time to HBsAg loss when compared to genotypes A and D.

Sustained virological response in patients with HCV treated with daclatasvir plus sofosbuvir, with or without ribavirin: a large, field-practice study.

Background: The once-daily oral combination of daclatasvir (DCV) and sofosbuvir (SOF), with or without ribavirin (RBV), is effective and well tolerated in patients with hepatitis C virus (HCV). However, further field-practice studies are necessary to investigate the effectiveness and safety of the DCV+SOF combination in diverse subpopulations of patients with HCV, including those who are more challenging to treat such as patients with a genotype 3 (G3) infection. The aim of this retrospective, multicenter, field-practice study was to investigate the therapeutic efficacy and safety of the oral combination of DCV and SOF, with or without RBV (DCV+SOF±RBV), in a large unselected cohort of patients with chronic HCV infection (CHC).

ERRATUM Drug-drug interactions in anti-HCV therapy: a comparison among options available in Italy.

Erratum Following publication of the original article (Le Infezioni in Medicina, 2019, vol:27 (4):pp:239-250) we became aware of the following errors : In table 3a, pag 245, the interaction between GLE/PIB and Omeprazole does not require dosage adjustments and the correct recommendation is A (allowed) instead of NR (not recommended). The original explanation in the text is correct.

Drug-drug interactions in anti-HCV therapy: a comparison among options available in Italy.

After a long period of interferon-and ribavirin-based therapy (IFN/RBV), a very fast evolution in the development of directly acting antivirals (DAAs) has now established a totally new paradigm for the treatment chronic HCV infection. An efficacy rate within the 95-100% interval, safer and more tolerable drugs, much shorter treatment duration and a quicker establishment of the sustained virological response (SVR) are among the most relevant properties of new DAAs as compared to former IFN/RBV therapies. The last wave of DAAs is also characterized by a lesser tendency to generate or being victim of drug-drug interactions.

Visceral leishmaniasis in a patient with active HBV/HDV co-infection.

Visceral leishmaniasis (VL) is an endemic infection in different regions of Italy and Europe caused by protozoan parasites of the genus Leishmania, transmitted to humans through sandflies bites. Reactivation after Solid Organ Transplantation was reported and could be a risk of organ rejection. A 48 years old woman was admitted to our hospital, complaining about low-grade fever, loss of weight and new onset pancytopenia in a known cirrhosis due to active HBV/HDV co-infection.

Efficacy and safety of interferon-free regimens in patients affected by chronic hepatitis C and psychiatric disorders.

The presence of psychiatric disorders (PD) in patients affected by chronic hepatitis C (CHC) was a major contraindication for the treatment with interferon (IFN)-based regimens. The novel IFN-free approach using the direct-acting antiviral agents (DAAs) is an interesting and promising chance for these subjects. In this retrospective analysis we focused the attention on the virological response and safety of CHC patients affected by PD and treated with IFN-free regimens.

Antiviral treatment with pegylated interferon and clinical outcomes in a cohort of immigrants patients affected by hepatitis delta: A retrospective analysis.

Chronic hepatitis delta (CHD) is the most severe chronic hepatitis, with no satisfactory treatment options and severe clinical outcomes. This infection is frequent in the migrant subjects from endemic areas, especially from Africa and East-Europe. The pegylated (PEG)-interferon α (IFN) is limited by side effects and poor response.

Indication of prophylactic vaccines as a tool for secondary prevention in HPV-linked disease.

Purpose: To determine whether quadrivalent HPV vaccination is effective in reducing recurrent disease in women with a previous history of HPV disease.

Methods: All women under 45 years of age treated for HPV-linked disease and with negative HPV test, cytology and colposcopy 3 months after treatment were enrolled. Women were randomly assigned into two groups: a group that received HPV vaccine post treatment and a group that was only submitted to follow-up.

Daclatasvir Plasma Levels in a Cohort of Patients with Hepatitis C Virus Infection Taking Methadone: A Prospective Analysis.

Unlabelled: Backround: The effect of methadone (MET) during therapy with novel direct-acting antiviral agents is still not fully understood. Currently, no data are available about the influence of MET on daclatasvir (DCV) plasma levels in patients affected by chronic hepatitis C (CHC). The aim of this study was to assess the DCV plasma concentrations in patients treated with sofosbuvir (SOF) plus DCV, with or without ribavirin (RBV) and with or without MET.

Vitamin D pathway gene polymorphisms affecting daclatasvir plasma concentration at 2 weeks and 1 month of therapy.

Aim: Vitamin D (VD) influences genetic expression through its receptor (VDR). VD pathway gene polymorphisms seem to influence antiviral drug pharmacokinetics and therapeutic outcome/toxicity. We investigated the association between daclatasvir (DCV) plasma concentrations and genetic variants (SNPs) associated with the VD pathway.

Pharmacogenetics of the anti-HCV drug sofosbuvir: a preliminary study.

Background: Sofosbuvir is a potent nucleotide HCV NS5B polymerase inhibitor that is also a P-glycoprotein (encoded by the ABCB1 gene) and breast cancer resistance protein (encoded by the ABCG2 gene) substrate. Concerning previous anti-HCV therapies, pharmacogenetics had a significant impact, particularly considering the association of interleukin28B polymorphisms with dual-therapy (ribavirin + pegylated IFN) outcomes.

Objectives: In this work, we investigated the association between sofosbuvir and its prevalent metabolite (GS-331007) plasma concentrations at 1 month of therapy and genetic variants (SNPs) in genes encoding transporters and nuclear factors (ABCB1, ABCG2 and HNF4α) related to sofosbuvir transport.

Vitamin D pathway genetic variants are able to influence sofosbuvir and its main metabolite pharmacokinetics in HCV mono-infected patients.

Vitamin D levels and genetic variants were associated with drug outcome/toxicity and concentrations. The plasma exposure of GS-331007, the main sofosbuvir metabolite, has been related to SVR. We evaluated the impact of polymorphisms in genes (CYP27B1, CYP24A1, VDBP and VDR) related to vitamin D pathway on sofosbuvir and GS-331007 plasma levels in HCV mono-infected patients at one month of treatment.

Retreatment with sofosbuvir/velpatasvir in cirrhotic patients with genotype-4 who failed a previous interferon-free regimen: a case series.

Background: The novel available interferon (IFN)-free regimens significantly improved the sustained virological response (SVR) in patients with chronic hepatitis C (CHC), without important side effects and with shorter duration of treatment. In a subset of patients, however, the treatment failure (TF) was due to the presence of resistance-associated substitutions (RAS) that lead to virological breakthrough (BT) or relapse. We analysed in this case series the role of RAS on the TF in cirrhotic patients with genotype (GT)4, treated with a previous IFN-free regimen, and retreated with the combination of sofosbuvir (SOF)/velpatasvir (VEL) for 12 or 24 weeks, without ribavirin (RBV).

Extended duration of treatment with peginterferon alfa-2a in patients with chronic hepatitis B, HBeAg-negative and E genotype: A retrospective analysis.

An alternative approach in the treatment of chronic hepatitis B (CHB) with pegylated (PEG)-interferon (IFN) is the prolonged course to 96 weeks of therapy, with higher sustained response (SR) than patients treated for 48 weeks. This result was confirmed in patients with CHB and D genotype, while no data are currently available about the prolonged course of PEG-IFN in E genotype. This retrospective analysis reported the role of different treatment duration of PEG-IFN on the SR in patients affected by CHB and E genotype.

Vitamin D pathway gene polymorphisms and hepatocellular carcinoma in chronic hepatitis C-affected patients treated with new drugs.

Purpose: Since HCV infection may lead to hepatocellular carcinoma (HCC) and vitamin D (deficiency) is related to cancer, we investigated if SNPs in genes involved in vitamin D pathway could predict HCV-related HCC presence in patients treated with new anti-HCV drugs.

Methods: Patients with chronic hepatitis C and treated with direct-acting antivirals were enrolled. SNPs in VDR, CYP27B1, CYP24A1 and GC genes were assessed through real-time PCR.

Role of ribavirin in the treatment of hepatitis C virus-associated mixed cryoglobulinemia with interferon-free regimens.

Mixed cryoglobulinemia (MC) is the most common extrahepatic manifestation of chronic hepatitis C (CHC), with the presence of symptoms in 10-15% of cases. There have been encouraging data regarding immunological and clinical responses in patients treated with the novel combinations of direct-acting antivirals (DAAs), but the role of ribavirin (RBV) in the treatment of MC has not yet been demonstrated. We prospectively enrolled 132 patients affected by MC and CHC, and virological, immunological and clinical responses were evaluated at 12 weeks after completion of treatment.

Correlation between entecavir penetration in peripheral blood mononuclear cells and HBV DNA decay during treatment of HBeAg-negative chronic hepatitis B.

Background: Recently, due to its high effectiveness and tolerability, the treatment of chronic hepatitis B with entecavir became a standard practice. However, limited knowledge is currently available about its pharmacokinetic behaviour and intracellular disposition. Recently, our group reported an inverse correlation between entecavir plasma concentrations and the HBV DNA decay at the first and third month of treatment, respectively.

Influence of ABCB11 and HNF4α genes on daclatasvir plasma concentration: preliminary pharmacogenetic data from the Kineti-C study.

Background: Daclatasvir is an inhibitor of HCV non-structural 5A protein and is a P-glycoprotein substrate. Pharmacogenetics has had a great impact on previous anti-HCV therapies, particularly considering the association of IL-28B polymorphisms with dual therapy outcome.

Objectives: We investigated the association between daclatasvir plasma concentrations at 2 weeks and 1 month of therapy and genetic variants (SNPs) in genes encoding transporters and nuclear factors (ABCB1, ABCB11 and HNF4α).