Valtrex (Valacyclovir Hydrochloride) - Summary

VALTREX SUMMARY

VALTREX (valacyclovir hydrochloride) is the hydrochloride salt of L -valyl ester of the antiviral drug acyclovir (ZOVIRAX® Brand, GlaxoSmithKline).

Herpes Zoster:   VALTREX is indicated for the treatment of herpes zoster (shingles).

Genital Herpes:   VALTREX is indicated for the treatment or suppression of genital herpes in immunocompetent individuals and for the suppression of recurrent genital herpes in HIV-infected individuals.

Cold Sores (Herpes Labialis):   VALTREX is indicated for the treatment of cold sores (herpes labialis).

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NEWS HIGHLIGHTS

Media Articles Related to Valtrex (Valacyclovir)

Epiphany Announces Positive Results From Its Phase 2b Trial In Shingles
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
Epiphany Biosciences announced results from its Phase 2b dose-ranging study of EPB-348 (valomaciclovir) in patients with shingles (herpes zoster) infection. The study's primary endpoint was non-inferiority of once-daily valomaciclovir compared to thrice-daily valacyclovir in terms of time to complete crusting of the shingles rash.

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Published Studies Related to Valtrex (Valacyclovir)

The course of pain in Bell's palsy: treatment with prednisolone and valacyclovir. [2009.09]
OBJECTIVE: To evaluate the effect of prednisolone and valacyclovir on ipsilateral pain around the ear and in the face or neck in Bell's palsy. The incidence and intensity of pain during the first 2 months of palsy and its prognostic value were also assessed... CONCLUSION: Prednisolone and/or valacyclovir did not affect the incidence or intensity of ipsilateral pain in Bell's palsy. The incidence of pain was similar during the first 2 weeks and then decreased. Presence of pain at Days 11 to 17 indicated a worse prognosis for facial recovery.

Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial. [2009.03]
BACKGROUND: Treatment of herpes simplex labialis (HSL) has been associated with modest benefits. This difficulty results from the rapid resolution of the disease accomplished by the immune system, which narrows the window of therapeutic opportunity. The immune response is also responsible for important clinical manifestations, including oedema and pain. The dual role of immune responses (protection, pathology) is well recognized in other infectious diseases. The addition of corticosteroids to antimicrobial agents has been associated with improvement in some of these diseases. OBJECTIVE: We evaluated the combination of oral valacyclovir plus topical clobetasol compared to placebo for recurrent HSL... CONCLUSIONS: This pilot study supports the addition of topical corticosteroids to an oral antiviral agent for the treatment of HSL. Larger studies need to confirm the safety and efficacy of this approach.

Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial. [2009.01.08]
Abstract Background Treatment of herpes simplex labialis (HSL) has been associated with modest benefits. This difficulty results from the rapid resolution of the disease accomplished by the immune system, which narrows the window of therapeutic opportunity...

Once daily valacyclovir for reducing viral shedding in subjects newly diagnosed with genital herpes. [2009]
OBJECTIVE: Genital herpes (GH) recurrences and viral shedding are more frequent in the first year after initial HSV-2 infection. The objective of this study was to provide the first evaluation of valacyclovir 1 g once daily compared to placebo in reducing viral shedding in subjects newly diagnosed with GH... CONCLUSION: In this study, the frequency of total and subclinical HSV-2 shedding was greater than reported in earlier studies involving subjects with a history of symptomatic genital recurrences. Our study is the first to demonstrate a significant reduction in viral shedding with valacyclovir 1 g daily compared to placebo in a population of subjects newly diagnosed with HSV-2 infection.

[Randomized controlled multi-center trial for treatment of varicella in pediatric patients with hydrochloride valacyclovir] [2008.06]
OBJECTIVE: To evaluate the efficacy and safety of hydrochloride valacyclovir in treatment of varicella in pediatric patients between April 2006 and March 2007... CONCLUSIONS: The hydrochloride valacyclovir was safe, reliable and convenient in treatment of uncomplicated varicella in children.

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Clinical Trials Related to Valtrex (Valacyclovir)

Fed Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GSK's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administration under fed conditions.

Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administration under fed conditions.

Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.

Evaluation Of Valaciclovir In Patients With Chickenpox [Active, not recruiting]
This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and valaciclovir in children with chickenpox following oral administration of valaciclovir, for the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.

VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2 [Completed]
Eligible subjects will be randomized to receive VALTREX 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days in between.

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PATIENT REVIEWS / RATINGS / COMMENTS

Valtrex review by 59 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		shingles
Dosage & duration:		1000 mg (generic) taken 4 times a day for the period of still taking at 800 mg 3 times a day
Other conditions:		developed Ramsay-Hunt syndrome prior to mega doses of acyclovir
Other drugs taken:		acupril 20 mg od, estratest hs od
		Reported Results
Benefits:		Prior to starting 1000 mg acyclovir QID, I was taking the standard 200 mg 5 times a day regimin. I devloped the shingles in the 5th cranial nerve. I had lesions following the entire nerve roots across my face, but had them internally as well. There were lesions in the ear canal, the side of my tongue and down my throat. I had taken a flu shot and had exposure to sun, as well as starting 2 new jobs about the same time as the first onset. I developed 1 blister which I thought was herpes. I had not had a herpes outbreak in years. I started the acyclovir and noticed more and different complaints every day. I first got a lesion on the entrance to the ear canal and more accompanying the first one on my lower chin. Then my lower teeth began to become painful, as if I had a great toothache. After about 4 days, I began to feel exhausted and unable to snap out of my fatigue. The next day I awoke and had a sensation that my mouth was not fully moving. Later the eye began to remain open and would not blink. The 3rd day of these symtoms, I devloped total paralysis of the left face. I saw 1 of my doctors immediately. He gave me a cortisone shot and told me the dose of acyclovir to take. He said it was bell's palsey. A friend called and said it was Ramsay-Hunt. I was on bedrest from Mid October until 2 weeks ago. I have very little stamina, and slowly I am getting more energy. The latest addition to my medication arsenal was Alpha-lipoic acid. I had statrted lysine and red marine algae. I stopped coffe, soda, most meat and ate only what little I cooked or made myself. I am pleased that most of my facial functions have returned, with the exception of the eye bliking completely, and a slight difference in my smile. I take at least 1 dose of ibuprophen every day due to neuralgia or a sense of swelling in my left face.
Side effects:		I did not notice any.
Comments:		acyclovir, rest. PRN doses of ibuprophen. Tape eye shut and use of moisture drops.

Valtrex review by 36 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Cold sore on side of face
Dosage & duration:		500 mg taken 1 tablet 2 times a day for the period of 7 days
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Drastically reduced the amount of time the cold sores were present on the side of face. Medication also made the cold sore break out less servere.
Side effects:		Side effects included initial headache until the body got used to the medication. Some dizziness and nausea was experienced, but minor.
Comments:		Treatment included medication 2 times a day. Instructions were to keep the area around the cold sore clean and to not touch the cold sore directly with hands. This would ensure the spread of the cold sores was minimized.

Valtrex review by 31 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Herpes
Dosage & duration:		500mg taken once per day for the period of 1 month
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Was taking this drug for herpes suppression. It is recommended by some to take an antiviral for one year after the initial outbreak so as to have less outbreaks over one's lifetime. I did get an outbreak while on the drug, however it was during a very stressful time so that is understandable. Also, it is nice that only one dose is needed per day for most people.
Side effects:		Side effects included mild hair loss (had much more hair loss on acyclovir), random dry heaving (retching) for no apparent reason, and headaches. Although it seems that when I drink lots of water the headaches are fewer.
Comments:		Took one pill per day at the same time everyday. It does and will stain things so be careful of the blue dye.