Doravirine Plus Integrase Strand Transfer Inhibitors as a 2-Drug Treatment-Switch Strategy in People Living with HIV: The Real-Life DORINI Multicentric Cohort Study.

Background: Few data are available about the efficacy, durability, and tolerability of doravirine (DOR) + integrase strand inhibitors (INI) as a switching strategy among antiretroviral therapy (ART)-experienced people living with HIV (PLWH).

Setting: Retrospective, multicenter cohort study investigating the durability, efficacy, and tolerability of 2 off-label drug associations of DOR + INI among ART-experienced PLWH.

Methods: The study included PLWH who switched to DOR combined with either raltegravir (RAL) or dolutegravir (DTG) between June 1, 2020, and December 31, 2021, with at least 1 follow-up (FU) visit.

Identification of Drugs Acting as Perpetrators in Common Drug Interactions in a Cohort of Geriatric Patients from Southern Italy and Analysis of the Gene Polymorphisms That Affect Their Interacting Potential.

Background: Pharmacogenomic factors affect the susceptibility to drug-drug interactions (DDI). We identified drug interaction perpetrators among the drugs prescribed to a cohort of 290 older adults and analysed the prevalence of gene polymorphisms that can increase their interacting potential. We also pinpointed clinical decision support systems (CDSSs) that incorporate pharmacogenomic factors in DDI risk evaluation.

New Avenues for Treatment and Prevention of Drug-Induced Steatosis and Steatohepatitis: Much More Than Antioxidants.

Drug-induced lipid accumulation in the liver may induce two clinically relevant conditions, drug-induced steatosis (DIS) and drug-induced steatohepatitis (DISH). The list of drugs that may cause DIS or DISH is long and heterogeneous and includes therapeutically relevant molecules that cannot be easily replaced by less hepatotoxic medicines, therefore making specific strategies necessary for DIS/DISH prevention or treatment. For years, the only available tools to achieve these goals have been antioxidant drugs and free radical scavengers, which counteract drug-induced mitochondrial dysfunction but, unfortunately, have only limited efficacy.

Darunavir Population Pharmacokinetic Model Based on HIV Outpatient Data.

Background: Darunavir is a second-generation protease inhibitor and is registered for the treatment of HIV-1 infection. The aim of this study was to develop and validate a darunavir population pharmacokinetic model based on data from daily practice.

Methods: Data sets were obtained from 2 hospitals: ASST Fatebenefratelli Sacco University Hospital, Italy (hospital A), and University Medical Center Groningen, the Netherlands (hospital B).

Evaluation of the concentrations of psychotropic drugs in HIV-infected versus HIV-negative patients: Potential implications for clinical practice.

The management of psychiatric illness in HIV-infected patients is clinically challenging because of the risk of potential drug-drug interactions. Here, we aimed to measure the antidepressant and/or antipsychotic drug concentrations in HIV-infected patients during routine outpatient visits. Six hundred HIV-infected patients were screened during the first 15 months after the introduction of our outpatient polytherapy management service in a search for subjects treated with psychotropic drugs for at least 3 months.

Uptake of hepatitis C virus treatment in HIV/hepatitis C virus-coinfected patients across Europe in the era of direct-acting antivirals.

Background And Aims: To investigate the uptake of hepatitis C virus (HCV) therapy among HIV/HCV-coinfected patients in the pan-European EuroSIDA study between 2011 and 2016.

Methods: All HCV-RNA+ patients were included. Baseline was defined as latest of anti-HCV+, January 2011 or enrolment in EuroSIDA.

Correlation between inner retinal layer thickness and cognitive function in HIV: new insights from an exploratory study.

Objective: To compare retinal layer thickness in HIV-infected subjects with (CI-HIV) and without (NCI-HIV) cognitive impairment, with a control population and to correlate this with the cognitive status of the patient and other clinical parameters.

Design: Single-center cross-sectional study.

Methods: Participants with controlled HIV infection aged between 40 and 70 years and sex-matched and age-matched controls were enrolled.

Effect of Cobicistat on Tenofovir Disoproxil Fumarate (TDF): What Is True for TAF May Also Be True for TDF.

Background: The dose of tenofovir alafenamide is reduced from 25 to 10 mg daily when given with boosting agents. However, such dose reduction has never been adopted for tenofovir disoproxil fumarate (TDF). In this study, we aim to quantify the effect of cobicistat (COBI) both on tenofovir concentrations and TDF durability in real life setting.

Generics for the Treatment of Hepatitis C in Monoinfected and HIV-coinfected Patients: Pros and Cons.

The treatment of hepatitis C virus in monoinfected and HIV-coinfected patients has greatly changed over recent years as a result of the introduction of direct-acting antiviral agents (DAAs), which have revolutionized clinical outcomes and led to sustained virological response rates above 90-95%. The discovery of new molecules and the subsequent competition between pharmaceutical companies, together with the negotiated price policies pursued by many national health systems, have led to a gradual reduction in the cost of DAAs, and expand their use to an increasing number of patients, including those with mild liver damage. However, the cost of branded DAAs is still too high for many developing countries, and many patients are still left without therapy.

Effect of Legal Status on the Early Treatment Outcomes of Migrants Beginning Combined Antiretroviral Therapy at an Outpatient Clinic in Milan, Italy.

Objective: In a setting of free access to HIV care, we compared the early treatment outcomes of HIV-infected undocumented migrants (UMs), documented migrants (DMs), and Italian subjects.

Methods: The clinical data of 640 Italians and 245 migrants who started combined antiretroviral therapy (cART) at an HIV clinic in Milan, Italy, were reviewed. The migrants were mainly Latin Americans (83 DMs and 56 UMs) or sub-Saharan Africans (52 DMs and 11 UMs), but a minority were of other origin (33 DMs and 10 UMs).

Elvitegravir/cobicistat-associated toxic optical neuropathy in an HIV-infected patient: a call for caution?

Ocular toxicity may not only be caused by medication overdoses and drug-drug interactions, but also by chronic administration of medications at recommended doses. We describe a case of an HIV-infected patient who experienced significant and sustained bilateral visual loss 2 months after starting treatment with elvitegravir/cobicistat/tenofovir/emtricitabine. Given the absence of any evidence of tenofovir- or emtricitabine-induced optical neuropathy after several years of clinical use, the antiretroviral therapy was promptly changed to tenofovir/emtricitabine plus atazanavir/ritonavir, which led to a progressive improvement in visual acuity.

Abacavir-induced liver toxicity.

Abacavir-induced liver toxicity is a rare event almost exclusively occurring in HLA B*5701-positive patients. Herein, we report one case of abnormal liver function tests occurring in a young HLA B*5701-negative woman on a stable nevirapine-based regimen with no history of liver problems or alcohol abuse after switching to abacavir from tenofovir. We also investigated the reasons for abacavir discontinuation in a cohort of patients treated with abacavir-lamivudine-nevirapine.

Changes in the incidence of severe thrombocytopenia and its predisposing conditions in HIV-infected patients since the introduction of highly active antiretroviral therapy.

Background: Severe thrombocytopenia (TCP, platelets <50 × 10⁹/L) is relatively frequent during HIV infection and is associated with bleeding risk and disease progression. We investigated the changes in the incidence of severe TCP and its predisposing conditions in a cohort of HIV-positive subjects.

Methods: The incidence and predictors of platelet counts <50 × 10⁹/L were investigated in all patients enrolled at our institution between 1985 and 2012.

Comparison of the pharmacokinetics of raltegravir given at 2 doses of 400 mg by swallowing versus one dose of 800 mg by chewing in healthy volunteers: a randomized, open-label, 2-period, single-dose, crossover phase 1 study.

Background: The pharmacokinetics of raltegravir (RAL) in HIV patients is characterized by high interindividual and intraindividual variability. We documented previously that HIV patients taking RAL at 400 mg bid by chewing the tablets had significantly higher drug absorption and reduced pharmacokinetic variability than patients taking the drug by swallowing the tablets. This study extends our previous findings.