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[LIVE BLOG – Seattle] Product Theater: Sponsored by PharmaDerm – VEREGEN (sinecatechins) Ointment, 15%

 

In this lecture, Dr. Ted Rosen addresses risk factors, prevention and treatment for HPV.  Dr. Rosen highlights Sinecatechins ointment (VEREGEN) as an effective first-line therapy.  VEREGEN is a botanical ointment derived from green tea.

 

 

Relative to vehicle, VEREGEN demonstrated efficacy as a first line treatment against EGW:

 

+ High rates of complete clearance (53.6%)

+ Statistically significant early onset of action

+ Complete clearance at 6 weeks in a small number of patients

+ Low rates of recurrence (6.8%)

 

 

HPV Incidence Rates (US, 2000)

+ Gonorrhea – 718,000 

     ++ There is now a new strain of Gonorrhea, resistant to every known antibiotic.

+ HSV – 1.6 million

+ Chlamadyia – 2.8 million

+ HPV 6.2 million

 

FACT: 15% of population (20 million) have HPV in genital region (as of 2004)

 

 

Here is a Snap Shot of HPV Life Cycle:

 

1. Virus comes in through small microabrasions 

2. Genes turns cell into a little factory of DNA and protein

3. Sheds on the skin surface and spreads

4. Median 2.9 weeks of incubation 

5. Weeks to months later the virus takes over the cell

 

Typically, patient’s immune system eradicates virus within a year

This doesn’t always mean it’s fully gone

 

Even without visible warts, a test run on a snipped piece of tissue can test positive

After a decade without full-healing, Cervical Cancer is the main risk

 

What are the Risk Factors for HPV?

– high number of sexual partners

– immunocompromised patients

– early age of intercourse

– shorter time interval between meeting partner and having sexual intercourse

– smoking cigarettes increases chances of genital warts AND genital herpes

**for every cigarette you smoke, your HPV risk increases by 6/10 of a percent!

– those using oral contraceptive as birth control option

 

 

HPV: Relationship with Lifetime and Current number of Sexual Partners

1 partner – 21.1% 

2 partners – 44.8%

3 partners – 63.6%

 

 

Diagnosis of EGW?

 

1. Rule out malignancy (if blue/black typically made by visual inspection

may be confirmed by biopsy)

2. Sudden recent growth/increased pigmentation

3. Fixation to underlying structures

4. Molecular testing for nucleic acids (HPV typing) not necessary for routine diagnosis

 

 

What are Prevention Strategies for HPV?

1. Reduce duration of infectiousness through treatment

2. Decrease transmission efficiency with consistent condom use

Condoms do not protect absolutely from HPV.  

3. Reduce/limit number of sexual partners

4. HPV vaccines

**Even if you are protected by an HPV vaccine, you are only protected for the viruses covered in the vaccine.  Other strains can still affect you.

 

2010 CDC STD Treatment Guidelines: Choosing the Best Treatment Modality

 

Treatment selection may be influenced by:

+ number and size of warts

+ anatomic size of wart

+ wart morphology

+ treatment costs

+ adverse effects

 

New CDC Treatment Guidelines (2010)

 

Provider Admin Treatment: 

1. Cryotherapy

2. Podophyllin resin

3. Surgical removal

 

Patient-Applied:

1. Podovilox gel (gen. not as effective, often changes histology)  – applied 2 x day

2. Imiquimod cream – applied 3 x week (tends to be unpredictably irritating, though successful; about 40% for women, 20% for men)

3. Sinecatechins ointment (der. of green tea) – applied to wart 3 x day up to 16 weeks 

 

Phase 3: Results – Complete Clearance

 

+ 60% females with complete clearance

+ 47% males with complete clearance 

 

+ Exceptionally successful with perianal warts

(Remember you may need to refer to a GI specialist.)

 

Low recurrence rates with VEREGEN Treatment:

+ Recurrence rate under 7%

+ Next best ever published is 9%

 

 

A SUMMARY OF VEREGEN AEs

 

1. Intended for patients 18 years and older

2. Patients should avoid exposure of Vergen treated areas to sun/UV light as it hasn’t yet been tested in those circumstances; safety hasn’t been established for immunosuppressed pediatric patients, or pregnant women; or for treatment of external genital and perianal warts beyond 16 weeks 

3. The most common adverse reactions are local skin and application site reactions: erythema, burning, pain/discomfort, erosion, edema, induration and vesicular rash

 

AEs (>3%)

Majority were mild to moderate; incidence of patience w/ local AEs leading to discontinuation was 2.3%

 

Notes:

1. VEREGEN is heat sensitive, so tell patients not to leave it in the car after visiting the pharmacy

2. On average, for the majority of patients, appx. 2.5 tubes of the product will be needed.

 

[image by motograf]
 

 




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