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Article ; Online: Clinical pharmacology of the SingleTablet Regimen (STR) Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF).

Di Perri, Giovanni

2023 Volume 31, Issue 3, Page(s) 283–289

Abstract: In Italy a proportion of HIV patients exceeding 50% are diagnosed at advanced stages of disease. A sizeable proportion of patients under chronic HIV treatment has a story of poor adherence with archived resistance associated mutations, a condition ... ...

Abstract	In Italy a proportion of HIV patients exceeding 50% are diagnosed at advanced stages of disease. A sizeable proportion of patients under chronic HIV treatment has a story of poor adherence with archived resistance associated mutations, a condition implying some risks in case of treatment with dual regimens. Conventional three-drug regimens will remain necessary in the short-mid term, in order to avoid treatment failure and selection of drug resistance. Efficacy, tolerability, safety, genetic barrier, forgiveness and a good compatibility with concurrent medications are all features that describe the overall quality of BIC/FTC/TAF, a combination whose robustness will remain a point of reference for the next years.
Language	English
Publishing date	2023-09-01
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	2041081-5
ISSN	2532-8689 ; 1124-9390
ISSN (online)	2532-8689
ISSN	1124-9390
DOI	10.53854/liim-3103-3
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Article ; Online: Pharmacological outlook of Lenacapavir: a novel first-in-class Long-Acting HIV-1 Capsid Inhibitor.

Di Perri, Giovanni

Le infezioni in medicina

2023 Volume 31, Issue 4, Page(s) 495–499

Abstract: The evolution of antiretroviral therapy is now addressed to develop regimens consisting of two instead of three drugs and it is also increasingly oriented to develop long-acting parenteral formulations in order to increase treatment adherence and to ... ...

Abstract	The evolution of antiretroviral therapy is now addressed to develop regimens consisting of two instead of three drugs and it is also increasingly oriented to develop long-acting parenteral formulations in order to increase treatment adherence and to reduce the multifaceted individual burden associated to daily intake of drugs. This new way was first paved by the dual association consisting of the INSTI Cabotegravir and the NNRTI Rilpivirine, whose formulations allow for a single administration every two months. In 2022 a new drug with a novel mechanism of action and a longer persistence of effective drug concentrations was made available in many countries for the treatment of drug-resistant HIV infection in association to other antiretrovirals. Lenacapavir is a first in class capsid inhibitor that exerts its inhibitory effect on HIV replication by binding to a structural protein of the capsid. This unprecedented mechanism of action actually differs from those of all prior antiretrovirals as Lenacapavir interferes with multiple stages rather than with a single enzyme. Such binding determines a series of inhibitory effects on sequential steps of the HIV life cycle and the net result is that of an impressive intrinsic antiretroviral potency, as testified both by
Language	English
Publishing date	2023-12-01
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	2041081-5
ISSN	2532-8689 ; 1124-9390
ISSN (online)	2532-8689
ISSN	1124-9390
DOI	10.53854/liim-3104-8
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Article ; Online: Tenofovir alafenamide (TAF) clinical pharmacology.

Di Perri, Giovanni

Le infezioni in medicina

2021 Volume 29, Issue 4, Page(s) 526–529

Abstract: Tenofovir today exists in two pharmaceutical forms, such as Tenofovir disoproxil fumarate (TDF) and the newer Tenofovir alafenamide (TAF). The two different salts are required in order to promote intestinal absorption of the active molecule (TFV). Once ... ...

Abstract	Tenofovir today exists in two pharmaceutical forms, such as Tenofovir disoproxil fumarate (TDF) and the newer Tenofovir alafenamide (TAF). The two different salts are required in order to promote intestinal absorption of the active molecule (TFV). Once absorbed the distribution of TFV into compartments is driven by the salt to which the drug is conjugated; in case of TDF, following absorption most of TFV is cleared from its link with the salt and the drug is widely distributed into different tissues, while in case of TAF the reverse is true as TFV remains mostly associated to its alafenamide salt and its distribution is restricted to cells with high carboxyesterase and catepsin A activity, such as hepatocytes and lymphocytes. This generates higher plasma levels of TFV in case of TDF while in the case of TFV much higher intracellular concentrations in target cells are achieved. The main reason for TAF development was to reduce the impact of the drug on proximal renal function and this was actually obtained by the much lower plasma concentration of TFV. Numerous clinical trials consistently demonstrated the significant lesser impact of TAF vs TDF on both renal function and structural bone integrity.
Language	English
Publishing date	2021-12-10
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	2041081-5
ISSN	2532-8689 ; 1124-9390
ISSN (online)	2532-8689
ISSN	1124-9390
DOI	10.53854/liim-2904-4
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Article: Biofilm Development and Approaches to Biofilm Inhibition by Exopolysaccharides.

Di Perri, Giovanni / Ferlazzo, Guido

The new microbiologica

2022 Volume 45, Issue 4

Abstract: Bacteria biofilm consists of microorganisms, accounting for 5-35% of the biofilm volume, and of the extracellular matrix (65-95%), made of water (97%), proteins (2%), polysaccharides (1-2%) and nucleic acids (DNA/RNA, both < 1%). The physiology of ... ...

Abstract	Bacteria biofilm consists of microorganisms, accounting for 5-35% of the biofilm volume, and of the extracellular matrix (65-95%), made of water (97%), proteins (2%), polysaccharides (1-2%) and nucleic acids (DNA/RNA, both < 1%). The physiology of bacteria in the biofilms entails adaptive changes with expression of genes which are different from those translated in the planktonic state. While most of our applied knowledge on bacterial biology stems from the study in the planktonic state, an increasing interest is currently paid to bacterial behaviour as biofilm generators, as it is estimated that 65% of all bacterial infections are associated with bacterial biofilms. Infections of both upper and lower airways, bacterial endocarditis, chronic otitis media, urinary tract infections, periodontitis, ocular infections and chronic wound infections (including diabetic foot ulcer) are all associated with biofilm formation. The role of biofilm is also relevant in case of infections taking place on abiotic surfaces, as in the case of infections occurring on prostheses and several other medical devices. Here, we review current knowledge on biofilm formation and its impact on human infections, discussing recent means for its inhibition, with particular emphasis on an interesting anti-biofilm activity exerted by exopolysaccharides derived from marine strains of Bacillus licheniformis.
Language	English
Publishing date	2022-10-03
Publishing country	Italy
Document type	Journal Article
ZDB-ID	756168-4
ISSN	1121-7138 ; 0391-5352
ISSN	1121-7138 ; 0391-5352
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Article: Tenofovir alafenamide revisited.

Di Perri, Giovanni

Le infezioni in medicina

2020 Volume 28, Issue 4, Page(s) 525–533

Abstract: Two Tenofovir pro-drugs are available for the treatment of HIV and HBV infection. Tenofovir Alafenamide (TAF) was clinically developed as a safer alternative to the older Tenofovir Disoproxil Fumarate (TDF) as the latter was consistently found to be ... ...

Abstract	Two Tenofovir pro-drugs are available for the treatment of HIV and HBV infection. Tenofovir Alafenamide (TAF) was clinically developed as a safer alternative to the older Tenofovir Disoproxil Fumarate (TDF) as the latter was consistently found to be associated to proximal renal tubule dysfunction and decrease in bone mineral density (BMD). As compared to TDF, the pharmacological properties of TAF are such that a more active drug is delivered into target cells while much less is measurable in general circulation. This translates into an antiretroviral action comparable to TDF with a significantly lower impact on proximal renal tubular function and bone structural integrity. The lipid-lowering effects of TDF as well as its lesser tendency to be associated to undesired body weight increase have raised some doubts about the substitution of TDF with TAF. Both issues, whose genesis is multifactorial, are strictly linked to the hypothesis of increased cardiovascular risk that might follow the switch from TDF to TAF. However, the long-term impact of decreasing renal function on cardiovascular risk must also be considered, especially in aging patients. It is thus a matter of balance: while the action on modifiable behavioural variables may well reduce lipid levels and body weight, the permanent dysfunctional pressure exerted by TDF on the proximal renal tubule could cause irreversible damage to both kidneys and bones. Therefore, all things considered, avoidance of TDF, particularly when aging patients are concerned, appears the preferable approach.
MeSH term(s)	Alanine ; Anti-HIV Agents/therapeutic use ; Anti-Retroviral Agents/therapeutic use ; Drug Substitution ; HIV Infections/drug therapy ; Humans ; Tenofovir/analogs & derivatives ; Tenofovir/therapeutic use
Chemical Substances	Anti-HIV Agents ; Anti-Retroviral Agents ; Tenofovir (99YXE507IL) ; tenofovir alafenamide (EL9943AG5J) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2020-11-27
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2041081-5
ISSN	1124-9390
ISSN	1124-9390
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Article: The rationale for Low-Molecular Weight Heparin (LMWH) use in SARS-CoV-2 infection

Di Perri, Giovanni

Le infezioni in medicina

2020 Volume 28, Issue suppl 1, Page(s) 52–56

Abstract: In spite of many ongoing attempts to repurpose existing antivirals, no drugs have emerged yet with the desirable activity against SARS-CoV-2. Hydroxychloroquine, lopinavir/ritonavir, remdesivir, umifenovir, favipiravir, ribavirin and beta-interferon-1 ... ...

Abstract	In spite of many ongoing attempts to repurpose existing antivirals, no drugs have emerged yet with the desirable activity against SARS-CoV-2. Hydroxychloroquine, lopinavir/ritonavir, remdesivir, umifenovir, favipiravir, ribavirin and beta-interferon-1 gave rise to variable but still inconsistent proof of clinical efficacy in the treatment of COVID-19. Pathogenetic studies have shown significant differences between commonly defined viral pneumonia and COVID-19 pulmonary disease. In severe forms, immune/inflammatory alterations reminiscent of disease forms like Macrophage Activation Syndrome (MAS) have been described, and therapeutic options other than anti-infective have been proposed and implemented, such as anti-inflammatory and anticoagulative agents. The thrombotic phenomena described in the pulmonary vascular bed of patients with severe COVID-19 suggest the administration of low-molecular weight heparin (LMWH) as standard measure in hospitalized patients with COVID-19.
MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/therapeutic use ; Alanine/analogs & derivatives ; Alanine/therapeutic use ; Anticoagulants/administration & dosage ; Anticoagulants/therapeutic use ; Antiviral Agents/administration & dosage ; Antiviral Agents/therapeutic use ; Biomarkers ; Coronavirus Infections/blood ; Coronavirus Infections/complications ; Coronavirus Infections/drug therapy ; Coronavirus Infections/physiopathology ; Critical Care/methods ; Disease Management ; Double-Blind Method ; Drug Combinations ; Drug Therapy, Combination ; Embolism/epidemiology ; Embolism/prevention & control ; Endothelium, Vascular/physiopathology ; Heparin, Low-Molecular-Weight/administration & dosage ; Heparin, Low-Molecular-Weight/therapeutic use ; Humans ; Hydroxychloroquine/therapeutic use ; Interferon beta-1b/therapeutic use ; Lopinavir/therapeutic use ; Macrophage Activation ; Pandemics ; Pneumonia, Viral/blood ; Pneumonia, Viral/complications ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/physiopathology ; Pulmonary Fibrosis/etiology ; Pulmonary Fibrosis/prevention & control ; Randomized Controlled Trials as Topic ; Ritonavir/therapeutic use ; Thromboembolism/epidemiology ; Thromboembolism/prevention & control ; Thrombophilia/blood ; Thrombophilia/drug therapy ; Thrombophilia/etiology ; Thrombosis/epidemiology ; Thrombosis/prevention & control
Chemical Substances	Anticoagulants ; Antiviral Agents ; Biomarkers ; Drug Combinations ; Heparin, Low-Molecular-Weight ; lopinavir-ritonavir drug combination ; Interferon beta-1b (145155-23-3) ; Lopinavir (2494G1JF75) ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Hydroxychloroquine (4QWG6N8QKH) ; Ritonavir (O3J8G9O825) ; Alanine (OF5P57N2ZX)
Keywords	covid19
Language	English
Publishing date	2020-06-05
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2041081-5
ISSN	1124-9390
ISSN	1124-9390
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: HBsAg kinetics after 7 years of therapy with tenofovir disoproxil fumarate in a cohort of naïve patients affected by chronic hepatitis B with different genotypes.

Boglione, Lucio / Lupia, Tommaso / Stroffolini, Giacomo / Dodaro, Valentina / Perri, Giovanni Di

Infectious medicine

2024 Volume 3, Issue 1, Page(s) 100087

Abstract: The role of different genotypes in nucleos(t)ide analogs (NAs) treatment is still debated. Previous studies conducted on special populations evidenced that the E genotype had the lower virological and serological response. This descriptive study aims to ... ...

Abstract	The role of different genotypes in nucleos(t)ide analogs (NAs) treatment is still debated. Previous studies conducted on special populations evidenced that the E genotype had the lower virological and serological response. This descriptive study aims to recognize the hepatitis B "s" antigen (HBsAg) decline during tenofovir disoproxil fumarate (TDF) treatment in a cohort of patient affected by chronic hepatitis B (CHB). We retrospectively included all patients with CHB treated with TDF between April 2007 and March 2012 with a duration of treatment of 7 years. Kinetics of HBsAg was determined as serological response in this cohort. We include 110 subjects; virological response was observed in all subjects with genotypes A, B, and D; in 17 patients with C genotype (94.4%) and 24 with E genotype (96%). HBeAg loss was observed in 2 patients with genotype A (50%), 3 with B (100%), 0 with C (0%), 1 with D (20%), and 1 with E genotype (25%). In multivariate analysis we observed as predictive factors of HBsAg decline the baseline level of HBsAg (OR = 1.467; 95%CI: 1.221-5.113;
Language	English
Publishing date	2024-02-01
Publishing country	China
Document type	Journal Article
ISSN	2772-431X
ISSN (online)	2772-431X
DOI	10.1016/j.imj.2024.100087
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Article: Clinical pharmacology of the single tablet regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).

Di Perri, Giovanni

Le infezioni in medicina

2019 Volume 27, Issue 4, Page(s) 365–373

Abstract: The fourth HIV strand-transfer integrase inhibitor (INSTI) has been released into the market as part of a single-tablet-regimen (STR) consisting of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The newest component is thus BIC, a booster- ...

Abstract	The fourth HIV strand-transfer integrase inhibitor (INSTI) has been released into the market as part of a single-tablet-regimen (STR) consisting of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The newest component is thus BIC, a booster-free INSTI with pharmacological characteristics similar to those of dolutegravir (DTG), including high intrinsic antiretroviral potency. The BIC-containing STR underwent clinical development in both treatment-naive and virologically suppressed patients and was found non-inferior to DTG-based comparator arms. In the currently evolving therapeutic scenario, the BIC/FTC/TAF STR regimen represents the smartest response on the side of triple conventional regimens, while new 2-drug regimens have received regulatory approval and nowadays epitomize the search for simpler and lighter antiretroviral regimens. The overall characteristics of BIC/FTC/TAF, however, make this therapeutic option quite comparable in terms of simplicity to the newly approved dual regimens, and the main reasons (e.g., toxicity) accounting in the past for the search of regimens consisting of less than three drugs are no longer in place.
MeSH term(s)	Adenine/administration & dosage ; Adenine/analogs & derivatives ; Adenine/pharmacology ; Anti-HIV Agents/administration & dosage ; Anti-HIV Agents/pharmacology ; Clinical Trials as Topic ; Drug Combinations ; Emtricitabine/administration & dosage ; Emtricitabine/pharmacology ; HIV Infections/drug therapy ; Heterocyclic Compounds, 4 or More Rings/administration & dosage ; Heterocyclic Compounds, 4 or More Rings/pharmacology ; Humans ; Tablets ; Tenofovir/administration & dosage ; Tenofovir/pharmacology
Chemical Substances	Anti-HIV Agents ; Drug Combinations ; Heterocyclic Compounds, 4 or More Rings ; Tablets ; emtricitabine tenofovir alafenamide ; bictegravir (8GB79LOJ07) ; Tenofovir (99YXE507IL) ; Emtricitabine (G70B4ETF4S) ; Adenine (JAC85A2161)
Language	English
Publishing date	2019-12-14
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	2041081-5
ISSN	1124-9390
ISSN	1124-9390
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Article: Ritonavir: 25 Years' Experience of Concomitant Medication Management. A Narrative Review.

Quercia, Romina / Di Perri, Giovanni / Pein, Carolina / Bodie, Jennifer / Singh, Ravi Shankar P / Hendrick, Victoria / Boffito, Marta

Infectious diseases and therapy

2024

Abstract: Ritonavir is a potent inhibitor of the cytochrome P450 3A4 enzyme and is commonly used as a pharmacokinetic (PK) enhancer in antiviral therapies because it increases bioavailability of concomitantly administered antivirals. Decades of experience with ... ...

Abstract	Ritonavir is a potent inhibitor of the cytochrome P450 3A4 enzyme and is commonly used as a pharmacokinetic (PK) enhancer in antiviral therapies because it increases bioavailability of concomitantly administered antivirals. Decades of experience with ritonavir-enhanced HIV therapies and, more recently, COVID-19 therapies demonstrate that boosting doses of ritonavir are well tolerated, with an established safety profile. The mechanisms of PK enhancement by ritonavir result in the potential for drug-drug interactions (DDIs) with several classes of drugs, thus making co-medication management an important consideration with enhanced antiviral therapies. However, rates of DDIs with contraindicated medications are low, suggesting these risks are manageable by infectious disease specialists who have experience with the use of PK enhancers. In this review, we provide an overview of ritonavir's mechanisms of action and describe approaches and resources available to mitigate adverse events and manage concomitant medication in both chronic and short-term settings.
Language	English
Publishing date	2024-04-12
Publishing country	New Zealand
Document type	Journal Article ; Review
ZDB-ID	2701611-0
ISSN	2193-6382 ; 2193-8229
ISSN (online)	2193-6382
ISSN	2193-8229
DOI	10.1007/s40121-024-00959-6
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Article: Concurrent and Subsequent Co-Infections of

Trunfio, Mattia / Scabini, Silvia / Rugge, Walter / Bonora, Stefano / Di Perri, Giovanni / Calcagno, Andrea

Microorganisms

2022 Volume 10, Issue 7

Abstract: We narratively reviewed the physiopathology, epidemiology, and management of co-infections ... ...

Abstract	We narratively reviewed the physiopathology, epidemiology, and management of co-infections in
Language	English
Publishing date	2022-06-23
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2720891-6
ISSN	2076-2607
ISSN	2076-2607
DOI	10.3390/microorganisms10071275
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