Posts filed under ‘Antivirales no HIV’

Baloxavir marboxil for uncomplicated influenza in adults and adolescents.

N Engl J Med 2018 Sep 6; 379:913.

Hayden FG et al.

BACKGROUND

Baloxavir marboxil is a selective inhibitor of influenza cap-dependent endonuclease. It has shown therapeutic activity in preclinical models of influenza A and B virus infections, including strains resistant to current antiviral agents.

METHODS

We conducted two randomized, double-blind, controlled trials involving otherwise healthy outpatients with acute uncomplicated influenza. After a dose-ranging (10 to 40 mg) placebo-controlled trial, we undertook a placebo- and oseltamivir-controlled trial of single, weight-based doses of baloxavir (40 or 80 mg) in patients 12 to 64 years of age during the 2016–2017 season. The dose of oseltamivir was 75 mg twice daily for 5 days. The primary efficacy end point was the time to alleviation of influenza symptoms in the intention-to-treat infected population.

RESULTS

In the phase 2 trial, the median time to alleviation of influenza symptoms was 23.4 to 28.2 hours shorter in the baloxavir groups than in the placebo group (P<0.05). In the phase 3 trial, the intention-to-treat infected population included 1064 patients; 84.8 to 88.1% of patients in each group had influenza A(H3N2) infection. The median time to alleviation of symptoms was 53.7 hours (95% confidence interval [CI], 49.5 to 58.5) with baloxavir, as compared with 80.2 hours (95% CI, 72.6 to 87.1) with placebo (P<0.001). The time to alleviation of symptoms was similar with baloxavir and oseltamivir. Baloxavir was associated with greater reductions in viral load 1 day after initiation of the regimen than placebo or oseltamivir. Adverse events were reported in 20.7% of baloxavir recipients, 24.6% of placebo recipients, and 24.8% of oseltamivir recipients. The emergence of polymerase acidic protein variants with I38T/M/F substitutions conferring reduced susceptibility to baloxavir occurred in 2.2% and 9.7% of baloxavir recipients in the phase 2 trial and phase 3 trial, respectively.

CONCLUSIONS

Single-dose baloxavir was without evident safety concerns, was superior to placebo in alleviating influenza symptoms, and was superior to both oseltamivir and placebo in reducing the viral load 1 day after initiation of the trial regimen in patients with uncomplicated influenza. Evidence for the development of decreased susceptibility to baloxavir after treatment was also observed. (Funded by Shionogi; JapicCTI number, 153090, and CAPSTONE-1 ClinicalTrials.gov number, NCT02954354. opens in new tab.)

FULL TEXT

https://www.nejm.org/doi/10.1056/NEJMoa1716197

 

FDA approves new drug to treat influenza [press release].

Silver Spring, MD: U.S. Food and Drug Administration; Oct 24, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624226.htm

December 27, 2019 at 8:23 am

2018 European Guideline on the organization of a consultation for Sexually Transmitted Infections.

J Eur Acad Dermatol Venereol. August 2019 V.33 N.8 P.1452-1458.

Gamoudi D, Flew S, Cusini M, Benardon S, Poder A, Radcliffe K.

This is an update of the 2012 IUSTI guideline. In this new version, we have expanded the sections on sexual history taking to include PEP and PrEP use, intimate partner and gender‐based violence, chemsex, swinging and psychosexual problems. We highlight the potential for the use of technology in the context of sexual health to facilitate sexual history taking and partner notification. We have explained the principle of safeguarding young and other vulnerable people who may present to services.

This guideline is primarily aimed at services provided in mainstream clinic/office environments, but increasingly many countries are seeing an era of rapid transition of sexual health services in which satellite clinics and online service provision are centre stage. Services are moving away from the main hospitals/clinics into smaller peripheral sites and various non‐traditional or outreach type settings such as saunas, brothels, bars, clubs, educational facilities, prisons and gay pride events. The advantage of such services is that it might allow hard‐to‐reach groups to be engaged with clinical services.1 We need a cohesive, multiagency approach to addressing the challenges associated with this style of service provision, if we are to harness the potential for decentralization of sexual health services while safeguarding the most vulnerable and remaining true to the founding principles of sexual health care.

FULL TEXT

https://onlinelibrary.wiley.com/doi/full/10.1111/jdv.15577

PDF

https://onlinelibrary.wiley.com/doi/pdf/10.1111/jdv.15577

August 14, 2019 at 3:49 pm

2018 European guideline on the organization of a consultation for sexually transmitted infections

Journal of The European Academy of Dermatology and Venereology

New in the 2018 guidelines

This is an update of the 2012 IUSTI guideline. In this new version, we have expanded the sections on sexual history taking to include PEP and PrEP use, intimate partner and gender‐based violence, chemsex, swinging and psychosexual problems. We highlight the potential for the use of technology in the context of sexual health to facilitate sexual history taking and partner notification. We have explained the principle of safeguarding young and other vulnerable people who may present to services.

This guideline is primarily aimed at services provided in mainstream clinic/office environments, but increasingly many countries are seeing an era of rapid transition of sexual health services in which satellite clinics and online service provision are centre stage. Services are moving away from the main hospitals/clinics into smaller peripheral sites and various non‐traditional or outreach type settings such as saunas, brothels, bars, clubs, educational facilities, prisons and gay pride events. The advantage of such services is that it might allow hard‐to‐reach groups to be engaged with clinical services.1 We need a cohesive, multiagency approach to addressing the challenges associated with this style of service provision, if we are to harness the potential for decentralization of sexual health services while safeguarding the most vulnerable and remaining true to the founding principles of sexual health care….

FULL TEXT

https://onlinelibrary.wiley.com/doi/full/10.1111/jdv.15577

PDF

https://onlinelibrary.wiley.com/doi/pdf/10.1111/jdv.15577

June 17, 2019 at 10:39 am

Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenza.

Clinical Infectious Diseases March 5, 2019 V.68 N.6 P.e1-e47.   

Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenza.

Uyeki TM1, Bernstein HH2, Bradley JS3,4, Englund JA5, File TM6, Fry AM1, Gravenstein S7, Hayden FG8, Harper SA9, Hirshon JM10, Ison MG11, Johnston BL12, Knight SL13, McGeer A14, Riley LE15, Wolfe CR16, Alexander PE17,18, Pavia AT19.

Abstract

These clinical practice guidelines are an update of the guidelines published by the Infectious Diseases Society of America (IDSA) in 2009, prior to the 2009 H1N1 influenza pandemic. This document addresses new information regarding diagnostic testing, treatment and chemoprophylaxis with antiviral medications, and issues related to institutional outbreak management for seasonal influenza. It is intended for use by primary care clinicians, obstetricians, emergency medicine providers, hospitalists, laboratorians, and infectious disease specialists, as well as other clinicians managing patients with suspected or laboratory-confirmed influenza. The guidelines consider the care of children and adults, including special populations such as pregnant and postpartum women and immunocompromised patients.

Published by Oxford University Press for the Infectious Diseases Society of America 2018.

FULL TEXT

https://academic.oup.com/cid/article/68/6/e1/5251935

PDF (CLIC en PDF)

May 1, 2019 at 6:23 pm

Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenza.

Clinical Infectious Diseases March 2019 V.68  N.6 e1–e47

Uyeki TM, Bernstein HH, Bradley JS, Englund JA, File TM Jr, Fry AM, et al.

These clinical practice guidelines are an update of the guidelines published by the Infectious Diseases Society of America (IDSA) in 2009, prior to the 2009 H1N1 influenza pandemic.

This document addresses new information regarding diagnostic testing, treatment and chemoprophylaxis with antiviral medications, and issues related to institutional outbreak management for seasonal influenza.

It is intended for use by primary care clinicians, obstetricians, emergency medicine providers, hospitalists, laboratorians, and infectious disease specialists, as well as other clinicians managing patients with suspected or laboratory-confirmed influenza.

The guidelines consider the care of children and adults, including special populations such as pregnant and postpartum women and immunocompromised patients.

FULL TEXT

https://academic.oup.com/cid/article/68/6/e1/5251935

PDF (CLIC en PDF)

March 20, 2019 at 3:42 pm

Effectiveness of the ribavirin in treatment of hantavirus infections in the Americas and Eurasia: a meta-analysis

Virus disease. September 2014 V.25 N.3 P. 385–389

Marcos L. Moreli,corresponding author Ariany C. Marques-Silva, Vagner A. Pimentel, and Vivaldo G. da Costa

Virology Laboratory, Federal University of Goiás, Jataí, Brazil

Marcos L. Moreli, Email: rb.gfu.iataj@ileromlm

Hemorrhagic fever with renal syndrome (HFRS) and hantavirus pulmonary syndrome (HPS) are transmitted to humans through infection with the old- and new-world hantaviruses, respectively.

Together these diseases affect tens of thousands of people every year, and no specific treatment is available.

To investigate whether ribavirin treatment for hantaviruses infections decreases disease severity, we conducted a meta-analysis involving human and animal studies.

After defining the research protocol and criteria for inclusion/exclusion, we identified seven studies. We found that in groups with HPS who were treated with ribavirin, there was no significant reduction in mortality (RR 0.99, 95 % CI 0.60–1.61, I2 = 0 %).

On the other hand, for animal group with HPS-like disease, there was significant increase in survival (RR 0.05, 95 % CI 0.01–0.34, I2 = 0 %).

For animal group infected with the old-world hantaviruses, treated with ribavirin, there was a statistically significant increase in survival (RR 0.56, 95 % CI 0.42–0.76, I2 = 64 %).

Similarly, for humans with HFRS treated, there was increase in survival (RR 0.28, 95 % CI 0.08–1), although only a study exist.

Our meta-analysis provides data that should be interpreted with caution, partly due to the limited number of studies available.

Additionally, the results of the application of ribavirin in the population with HPS could not be determined, particularly in patients in the end stage of this disease.

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4188213/pdf/13337_2014_Article_219.pdf

January 12, 2019 at 12:17 pm

Infections in patients affected by rheumatologic diseases associated to glucocorticoid use or tumor necrosis factor-alpha inhibitors.

Rev Chilena Infectol. April 2014 V.31 N.2 P.181-95.

[Article in Spanish]

Fica A.

Abstract

A great diversity of infectious agents can affect patients that use steroids at immunosuppressive doses or tumor necrosis factor alpha (TNF-alpha) antagonists.

The list of participating microorganisms is more restricted in the case of anti TNF-alpha blockers.

Overlapping agents include intracellular bacteria, Mycobacterium tuberculosis, geographic fungal agents that have the ability to establish granulamotous infections, herpes zoster, and reactivation of chronic hepatitis B virus infection.

An important conceptual issue for these infections is the existence of a threshold prednisone daily dose for the emergence of opportunistic infections but higher levels of immunosuppression and cofactors are required in the case of Pneumocystis jiroveci and cytomegalovirus infections.

In order to prevent these threats, a detailed medical evaluation is needed before prescription to detect potential risks and manage them properly.

Prevention rules must be prescribed in every case, that include common sense behaviors, vaccines, and in selected cases, chemoprophylaxis for latent tuberculosis (TB) infection, P. jiroveci pneumonia (PCP) or other specific requirements.

Latent TB infection is probable and requires chemoprophylaxis in the case of remote or recent exposure to a patient with lung TB, a positive tuberculin or interferon-gamma release assay result or residual lung scars in a chest x-ray exam.

PCP prevention is suggested when the patient reaches a daily dose of prednisone of 30 mg but might be needed at lower doses in case of other concomitant immunosuppressive drugs or when lymphopenia arises shortly after prednisone initiation.

PDF

https://scielo.conicyt.cl/pdf/rci/v31n2/art09.pdf

 

November 19, 2018 at 11:12 am

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