Sunday, September 5, 2010

Influenza Virus Vaccine for the 2010-2011 Season

Cumulative 2010/2011 Season Lot Release Status (Updated 9/1/2010)
Flu vaccine lots that have been released by FDA and are available for distribution by the manufacturers.

Vaccine & Manufacturer Total number of Lots Released by FDA

AFLURIA
CSL Limited 22

Fluarix
GlaxoSmithKline Biologicals 5

FluLaval
ID Biomedical Corp. of Quebec 27

FluMist
MedImmune, LLC 14

Fluvirin
Novartis Vaccines and Diagnostics Limited 32

Fluzone
Sanofi Pasteur, Inc. 62

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Bethesda, Maryland, on February 22, 2010, to select the influenza viruses for the composition of the influenza vaccine for the 2010-2011 U.S. influenza season. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2009-2010 vaccines, and the availability of candidate strains and reagents.
The committee recommended that vaccines to be used in the 2010-2011 influenza season in the U.S. contain the following:
an A/California/7/09 (H1N1)-like virus; *
an A/Perth /16/2009 (H3N2)-like virus; **
a B/Brisbane/60/2008-like virus.***
The influenza vaccine composition to be used in the 2010-2011 influenza season in the U.S. is identical to that recommended by the World Health Organization on February 18, 2010, for the Northern Hemisphere's 2010-2011 influenza season.

*A/California/7/09 (H1N1)-like virus is the pandemic (H1N1) 2009 influenza virus. A monovalent vaccine containing this strain was made available to the United States in the fall of 2009.
**A/Perth/16/2009 (H3N2)-like virus is a change from the 2009-2010 influenza vaccine formulation.
***and B/Brisbane /60/2008-like virus is a current vaccine virus.

[Source: FDA]

Tuesday, August 31, 2010

Management of Treatment of Chronic Hepatitis B

1. Goals of therapy and treatment endpoints for Chronic Hepatitis B:
* Goal of therapy: Long term viral suppression to prevent long term clinical outcomes such as death from liver disease and development of liver cancer.
* Treatment endpoint:
- Improve liver histology
- Normalize ALT
- Decrease HBV DNA
- HBeAg loss and seroconversion to Anti-HBe or to Anti-HBs (+)

2. APASL 2008 Guidelines for Hepatitis (1): Starting treatment
- HBV DNA> 100,000 copies/mL (20,000IU/mL) in HBeAg-positive patients
- Or HBV DNA> 10,000 copies/mL (2000 IU/mL) in HBeAg-negative patients
- ALT > 2 x upper limit of normal.

3. EASL 2009 Guidelines for Hepatitis (2): For both HBeAg+ve and HBeAg-ve Chronic Hepatitis B
- HBV DNA> 200IU/mL (approximately 10^4 copies/mL) and/or
- ALT > ULN and
- Live biopsy showing moderate to severe active necroinflammation and/or fibrosis using a standardized scoring system.

Reference:
1. Liaw FW et al. Hepatol Int 2008; 2: 263-83
2. EASL Practice Guidelines J Hepatol 2009; 50: 227-42

Sunday, August 29, 2010

Classification of antibacterial drugs

Antibacterial drugs or antibiotic drugs are commonly use medicine for all kind of infections, hence we have to know about this drugs more clearer.


According to side of action, antibiotic divided into 3 main groups:


1. Inhibition of cell wall synthesis:

Beta-lactams, the structure of which contains a beta-lactam ring. The major subdivisions are:

  • penicillins whose official names usually include or end in 'cillin'.
  • cephalosporins and cephamycins which are recognised by the inclusion of 'cef' or 'ceph' in their official names.

Lesser categories of beta-lactams include:

  • carbapenems (e.g. meropenem...)
  • monobactams (e.g. aztreonam...)
  • beta-lactamse inhibitors (e.g. clavulanic acid...)

Other inhibitors of cell wall synthesis include vancomycine and teicoplanin.


2. Inhibition of protein synthesis:

Aminiglycoside. The names of those that are derived from streptomyces end in 'mycin', e.g. tobramycin. Other include gentamicin and semisynthesis drugs, e.g.amikacin.

Tetracyclines as the name suggests are four-ringed structures and their names end in '-cycline'

Macrolides, e.g.erythromycin. Clindamicin, structurally a lincosamide, has a similar action and overlapping antibacterial activity.

Other drugs that act by inhibiting protein synthesis include quinapristin-dalfopristin, linezolid, chloraphenicol and sodium fursidate.


3. Inhibition of nucleic acid synthesis:

Sulphonamides, usually their names contain 'sulpha' or 'sulfa'. These drugs, and trimethophrim, with which they may be combined, inhibit synthesis of nucleic acid precursors.

Quinolones, are structurally related to nalidixic acid; the names of the most recently introduced members of the group end in '-oxacin', e.g. ciprofloxacin. They act by preventing DNA replication.

Azoles, all contain an azole ring and the names end in '-azole', e.g. metronidazole. They act by the prodcution of short-lived intermediat compounds which are toxic to DNA of sensitive organisms. Rifapicin inhibits bacterial DNA-dependent RNA polymerase.


[To be continued... ]

Source: Clinical Pharmacology, 9th edition, P.N.Bennett and M.J.Brown, 2003