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Viruses
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Efficacy and Safety of Antiviral Therapy
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Efficacy and Safety of Antiviral Therapy

A topical collection in Viruses (ISSN 1999-4915). This collection belongs to the section "Viral Immunology, Vaccines, and Antivirals".

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Editors

Prof. Dr. Giordano Madeddu

E-Mail Website
Collection Editor
Department of Medicine, Surgery, and Pharmacy, University of Sassari, 07100 Sassari, Italy
Interests: HIV infection; antiretroviral therapy; HIV non infectious comorbidities; SARS-CoV-2; viral hepatitis in prison setting
Special Issues, Collections and Topics in MDPI journals
Dr. Andrea De Vito

E-Mail
Collection Editor
Department of Medicine, Surgery, and Pharmacy, University of Sassari, 07100 Sassari, Italy
Interests: HIV; antiviral treatment; HIV resistances; zoonotic diseases; SARS-CoV-2; COVID-19; bacterial infections
Special Issues, Collections and Topics in MDPI journals
Dr. Agnese Colpani

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Collection Editor
Department of Medicine, Surgery, and Pharmacy, University of Sassari, 07100 Sassari, Italy
Interests: HIV infection; sexually transmitted infection; prevention; SARS-CoV-2 infection; viral infection; parasitology
Special Issues, Collections and Topics in MDPI journals

Topical Collection Information

Dear Colleagues,

During the last years, a great effort has been made to improve antiviral treatments. Also, new strategies are at the door.

SARS-CoV-2 has been a testing ground for new treatment strategies developed in a very short time frame, with apparently few mild adverse events reported. Additionally, antiretroviral therapy (ART) has embraced new molecules and new formulations, with the first injective ART already available in many countries for the treatment of HIV. Furthermore, interesting breakthroughs have been made in the field of hepatitis, creating the chance of hepatitis C eradication in the foreseeable future. Moreover, the first treatment for hepatitis delta has been introduced. Finally, regarding Herpesviridae, new strategies are being developed, including genomic editing techniques, and new drugs have already been introduced.

All these new treatment strategies and others that are not mentioned in the above paragraph have been shown to be extremely promising in clinical trials. However, further real-life studies are needed to better assess the efficacy, the burden of adverse events and their pathophysiological mechanisms.

Prof. Dr. Giordano Madeddu
Dr. Andrea De Vito
Dr. Agnese Colpani
Collection Editors

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Keywords

  • antiviral treatment
  • CMV
  • HBV
  • HCV
  • HDV
  • HIV
  • SARS-CoV-2
  • efficacy
  • adverse events
  • tolerability

Published Papers (4 papers)

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2025

Jump to: 2024

13 pages, 824 KiB  
Article
Assessment of Response and Safety of Bulevirtide Treatment in Patients with Chronic Delta Virus Infection: The ARISTOTLE Pilot Observational Study
by Luca Rinaldi, Mauro Viganò, Alessia Ciancio, Alfredo Caturano, Vincenzo Messina, Grazia Anna Niro, Nicolina Capoluongo, Alessandro Loglio, Letizia Marinaro, Aldo Marrone, Ernesto Claar, Maurizio Russello, Emanuela Ciracì, Umberto Vespasiani Gentilucci, Valeria Pace Palitti, Carlo Acierno, Clelia Cosentino, Andrea Mormone, Rosa Cotugno, Francesca Terracciani, Paolo Gallo, Maria Rita Cannavò, Valerio Rosato, Ferdinando Carlo Sasso, Chiara Petrucciello, Giulio Petronio Petronio, Giovanni Villone, Francesco Benanti, Giuseppe Cariti, Elisabetta Falbo, Marco Distefano, Rodolfo Sacco, Alessandro Perrella and Antonio Izziadd Show full author list remove Hide full author list
Viruses 2025, 17(2), 251; https://doi.org/10.3390/v17020251 - 12 Feb 2025
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Abstract
Introduction: Hepatitis D virus (HDV) infection remains a significant global health challenge due to its severity and high risk of progression to cirrhosis and hepatocellular carcinoma (HCC). Bulevirtide, a novel HDV entry inhibitor, has shown promise in managing chronic hepatitis D by blocking [...] Read more.
Introduction: Hepatitis D virus (HDV) infection remains a significant global health challenge due to its severity and high risk of progression to cirrhosis and hepatocellular carcinoma (HCC). Bulevirtide, a novel HDV entry inhibitor, has shown promise in managing chronic hepatitis D by blocking viral entry into hepatocytes. This study evaluated the efficacy and safety of bulevirtide in reducing HDV RNA levels and improving liver function in a real-life cohort of Italian patients with HDV infection. Methods: This multicenter prospective trial enrolled 108 consecutive patients with chronic HDV infection, from June 2023 to June 2024, who received 2 mg/day of bulevirtide in combination with a nucleoside/nucleotide analogue for hepatitis B virus (HBV) infection. Patients with any stage of liver fibrosis or compensated cirrhosis were included. Data collected included demographic and clinical characteristics, liver function tests, HDV RNA levels, and adverse events at baseline and 6 months. Results: The virological response was achieved in 54.6% of patients (n = 59), with 36 demonstrating undetectable HDV RNA levels. Among responders, ALT levels decreased significantly from 67.0 U/mL [IQR 44.0–116.3] to 31.5 U/mL [IQR 24.0–36.5, p = 0.001], and AST levels from 66.0 U/mL [IQR 46.5–91.0] to 32.5 U/mL [IQR 28.0–38.0, p = 0.021]. Median HDV RNA dropped from 29,800 IU/mL [IQR 3100–375,000] to 0 IU/mL [IQR 0–291, p < 0.001]. No significant predictors of response emerged. Mild adverse events, including pruritus (5.6%) and injection-site reactions (1.9%) and flu-like syndrome (0.9) were reported, with no treatment discontinuation. Conclusions: Bulevirtide effectively reduces HDV RNA levels and improves liver function with a favorable safety profile, offering a promising therapeutic option for chronic hepatitis D. Further large-scale studies are needed to confirm these findings and explore long-term outcomes. Full article
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10 pages, 867 KiB  
Article
Comparative Analyses of Antiviral Potencies of Second-Generation Integrase Strand Transfer Inhibitors (INSTIs) and the Developmental Compound 4d Against a Panel of Integrase Quadruple Mutants
by Steven J. Smith, Xue Zhi Zhao, Stephen H. Hughes and Terrence R. Burke, Jr.
Viruses 2025, 17(1), 121; https://doi.org/10.3390/v17010121 - 16 Jan 2025
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Abstract
Second-generation integrase strand transfer inhibitors (INSTIs) are strongly recommended for people living with HIV-1 (PLWH). The emergence of resistance to second-generation INSTIs has been infrequent and has not yet been a major issue in high-income countries. However, the delayed rollouts of these INSTIs [...] Read more.
Second-generation integrase strand transfer inhibitors (INSTIs) are strongly recommended for people living with HIV-1 (PLWH). The emergence of resistance to second-generation INSTIs has been infrequent and has not yet been a major issue in high-income countries. However, the delayed rollouts of these INSTIs in low- to middle-income countries during the COVID-19 pandemic combined with increased transmission of drug-resistant mutants worldwide are leading to an increase in INSTI resistance. Herein, we evaluated the antiviral potencies of our lead developmental INSTI 4d and the second-generation INSTIs dolutegravir (DTG), bictegravir (BIC), and cabotegravir (CAB) against a panel of IN quadruple mutants. The mutations are centered around G140S/Q148H, including positions L74, E92, and T97 combined with E138A/K/G140S/Q148H. All of the tested INSTIs lose potency against these IN quadruple mutants compared with the wild-type IN. In single-round infection assays, compound 4d retained higher antiviral potencies (EC50 values) than second-generation INSTIs against a subset of quadruple mutants. These findings may advance understanding of mechanisms that contribute to resistance and, in so doing, facilitate development of new INSTIs with improved antiviral profiles. Full article
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2024

Jump to: 2025

8 pages, 869 KiB  
Brief Report
Probability of Starting Two-Drug Regimen (2DR) vs. Three-Drug Regimen (3DR) in ART-Naïve and ART-Experienced Person with HIV (PWH) Across the First Wave of COVID-19 Pandemic
by Alessandra Vergori, Nicola Gianotti, Alessandro Tavelli, Camilla Tincati, Andrea Giacomelli, Elena Matteini, Giuseppe Lapadula, Lucia Taramasso, Loredana Sarmati, Antonella D’Arminio Monforte, Andrea Antinori, Alessandro Cozzi-Lepri and on behalf of the ICONA Foundation Study
Viruses 2024, 16(12), 1822; https://doi.org/10.3390/v16121822 - 23 Nov 2024
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Abstract
Background: This study examined the impact of the COVID-19 lockdown on antiretroviral therapy (ART) prescriptions among persons living with HIV (PWH) in Italy. Methods: Data from the ICONA cohort included ART-naïve individuals who started ART between January 2019 and December 2022, [...] Read more.
Background: This study examined the impact of the COVID-19 lockdown on antiretroviral therapy (ART) prescriptions among persons living with HIV (PWH) in Italy. Methods: Data from the ICONA cohort included ART-naïve individuals who started ART between January 2019 and December 2022, and ART-experienced individuals who started new ART with HIV RNA ≤50 cps/mL from January 2016 to December 2022. The analysis focused on the proportion of PWH starting or switching to dual (2DR) versus triple (3DR) ART regimens. Comparisons were made using Chi-square and Kruskal-Wallis tests, with logistic regression (LR) to assess associations, adjusting for sex and age. Results: Among 2481 ART-naïve PWH, 17% were female, with a median age of 40. Using 2020 as the comparator (the lockdown year), the odds ratio (OR) from fitting a LR showed a reduced probability of prescribing 2DR both before and after 2020. The proportion of PWH starting 2DR was 9% in 2019, 18% in 2020, 13% in 2021, and 10% in 2022. Among 12,335 ART-experienced PWH, 20% were female, with a median age of 47. The proportion switching to 2DR rose from 24% in 2016 to 38% in 2020, 62% in 2021, and 65% in 2022, showing a >3-fold higher probability to be switched to 2DR instead of 3DR in recent years (2021-2022). Conclusions: For ART-naive PWH, 2DR initiation did not decrease during the 2020 lockdown but changed in the following years, possibly indicating shifts in clinical practice or resuming HIV services. For ART-experienced PWH, 2DR prescriptions increased significantly over time, especially for INSTI-based regimens. Full article
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12 pages, 2519 KiB  
Article
Achievement of Primary Prevention Cardiometabolic Targets in Women with HIV: An Urgent Call to Action to Pursue Cardiovascular Health
by Maria Mazzitelli, Vincenzo Scaglione, Claudia Cozzolino, Marco Zuin, Cristina Putaggio, Beatrice Bragato, Eleonora Vania, Lolita Sasset, Davide Leoni, Vincenzo Baldo and Annamaria Cattelan
Viruses 2024, 16(4), 578; https://doi.org/10.3390/v16040578 - 9 Apr 2024
Cited by 1 | Viewed by 1581
Abstract
Background: Cardiometabolic health has become crucial, especially for women with HIV (WWH). We assessed the achievement of targets for hypertension, dyslipidemia, and diabetes (H/Dy/DT) in primary prevention in a WWH cohort. Methods: Cross-sectional analysis including all WWH in our clinic, excluding those who [...] Read more.
Background: Cardiometabolic health has become crucial, especially for women with HIV (WWH). We assessed the achievement of targets for hypertension, dyslipidemia, and diabetes (H/Dy/DT) in primary prevention in a WWH cohort. Methods: Cross-sectional analysis including all WWH in our clinic, excluding those who had a myocardial infarction. H/Dy/DT achievement was assessed by both EACS guidelines and individual cardiovascular risk, CVR (measured by ESC calculator), using logistic regression to evaluate differences in H/Dy/DT achievement between migrant and Italian women. Results: We included 292 WWH, 55.5% Italian and 44.5% migrant women; the median age was 50 (IQR:42–58) years, 94.5% had undetectable HIV-RNA, 55.1% had a high level of education, 27.1% were smokers, and 19.2% did regularly physical exercise. Overall, 76%, 19%, and 5% of women presented a low, a high, and a very high CVR, respectively. Among Italians, 28.4% and 6.2% women presented a high and a very high CVR, respectively. Considering migrants, 7.7% and 3.8% women presented a high and a very high CVR, respectively. Overall, among migrant women, those with a high CVR were more likely to be not at target than those with a low risk (especially for LDL-c and blood pressure among people on treatment), despite the fact that we did not detect a statistically significant difference. By contrast, migrants were more likely to achieve glycemic targets than Italians (p = 0.032). Conclusions: H/Dy/DT target achievement is suboptimal, especially in migrants. A more aggressive pharmacological treatment, also assessing adherence to medical prescriptions, and promotion of healthy lifestyle should be urgently implemented, possibly redrawing the current model of care. Full article
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