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Valtrex (Valacyclovir Hydrochloride) - Summary

 
 



VALTREX SUMMARY

VALTREX (valacyclovir hydrochloride) is the valyl ester of the antiviral drug acyclovir.

Adult Patients

Cold Sores (Herpes Labialis): VALTREX® (valacyclovir hydrochloride) Caplets are indicated for treatment of cold sores (herpes labialis). The efficacy of VALTREX initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established.

Genital Herpes: Initial Episode: VALTREX is indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with VALTREX when initiated more than 72 hours after the onset of signs and symptoms has not been established.

Recurrent Episodes: VALTREX is indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with VALTREX when initiated more than 24 hours after the onset of signs and symptoms has not been established.

Suppressive Therapy: VALTREX is indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-1?infected adults. The efficacy and safety of VALTREX for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV-1?infected patients have not been established.

Reduction of Transmission: VALTREX is indicated for the reduction of transmission of genital herpes in immunocompetent adults. The efficacy of VALTREX for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of VALTREX for the reduction of transmission of genital herpes in individuals with multiple partners and non?heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines).

Herpes Zoster: VALTREX is indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of VALTREX when initiated more than 72 hours after the onset of rash and the efficacy and safety of VALTREX for treatment of disseminated herpes zoster have not been established.

Pediatric Patients

Cold Sores (Herpes Labialis): VALTREX is indicated for the treatment of cold sores (herpes labialis) in pediatric patients aged greater than or equal to 12 years. The efficacy of VALTREX initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established.

Chickenpox: VALTREX is indicated for the treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years. Based on efficacy data from clinical trials with oral acyclovir, treatment with VALTREX should be initiated within 24 hours after the onset of rash [see Clinical Studies].

Limitations of Use

The efficacy and safety of VALTREX have not been established in:

  • •Immunocompromised patients other than for the suppression of genital herpes in HIV?1?infected patients with a CD4+ cell count greater than or equal to 100 cells/mm3.
  • •Patients aged less than 12 years with cold sores (herpes labialis).
  • •Patients aged less than 2 years or greater than or equal to 18 years with chickenpox.
  • •Patients aged less than 18 years with genital herpes.
  • •Patients aged less than 18 years with herpes zoster.
  • •Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.

See all Valtrex indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Valtrex (Valacyclovir)

A pilot study examining the safety and tolerability of valacyclovir in veterans with hepatitis C virus/herpes simplex virus type 2 coinfection. [2014]
(HCV) coinfection... CONCLUSIONS: Valacyclovir 1 g twice daily showed no evidence of hepatotoxicity in

Valacyclovir therapy does not reverse herpes-associated alterations in cervical immunology: a randomized, placebo-controlled crossover trial. [2014]
Herpes simplex virus type 2 (HSV-2) infection is associated with a 3-fold increase in the risk of human immunodeficiency virus (HIV) acquisition, perhaps through alterations in mucosal HIV-susceptible target cells. We performed a clinical trial to assess the impact of herpes therapy on cervical immunology in HSV-2-infected, HIV-uninfected women from Africa or the Caribbean who were living in Toronto, Canada.

ASP2151 for the treatment of genital herpes: a randomized, double-blind, placebo- and valacyclovir-controlled, dose-finding study. [2012]
replication... CONCLUSIONS: Three-day or single-day courses of ASP2151 appear to be effective

Valacyclovir suppressive therapy reduces plasma and breast milk HIV-1 RNA levels during pregnancy and postpartum: a randomized trial. [2012]
mother-to-child transmission (PMTCT) interventions is unknown... CONCLUSIONS: Valacyclovir significantly decreased early breast milk and plasma

Lack of a pharmacokinetic interaction between steady-state tipranavir/ritonavir and single-dose valacyclovir in healthy volunteers. [2011.03]
OBJECTIVE: This study assessed the single-dose pharmacokinetics of the herpes antiviral acyclovir (administered as the pro-drug valacyclovir) alone and in combination with twice-daily 200 mg ritonavir-boosted tipranavir (500 mg) at steady state... CONCLUSIONS: When administered as a single dose of valacyclovir with steady-state tipranavir/ritonavir, there were no clinically important changes in acyclovir pharmacokinetics. This result indicates that valacyclovir can be co-administered safely with no dose adjustments.

more studies >>

Clinical Trials Related to Valtrex (Valacyclovir)

VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects [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 between treatment periods.

Valacyclovir 1000 mg Tablet Under Fed Conditions [Completed]
The objective of this study was to compare the rate and extent of absorption of Teva Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir, administered as 1 x 1000 mg tablet under fed conditions.

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.

Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions [Completed]

Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes [Completed]
This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b. i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b. i.d).

more trials >>

Reports of Suspected Valtrex (Valacyclovir) Side Effects

Renal Failure Acute (58)Altered State of Consciousness (49)Encephalopathy (42)Dysarthria (41)Blood Creatinine Increased (39)Renal Impairment (36)Dizziness (32)Blood Urea Increased (26)Drug Ineffective (25)Malaise (25)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 28 ratings/reviews, Valtrex has an overall score of 8.68. The effectiveness score is 8.71 and the side effect score is 8.57. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

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 40 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Cold Sores
Dosage & duration:   2000 mg twice per day, for 1 day taken 1 day for the period of 2 yrs
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   Significantly diminished the symptoms and size of the cold sore. Often, it would halt the development and the redness and swelling would disappear after a day or two, without the sore blistering/weeping/scabbing. For my body, Valtrex has proven to be far more effective than either Famvir, or Zoviraz. It is surprising how many people either do not treat cold sores, or are not aware of any new treatments after Zovirax.
Side effects:   Slight dizziness and tiredness, very minor.
Comments:   2x 1000mg tablets every 12 hours for 1 day.

 

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.

See all Valtrex reviews / ratings >>

Page last updated: 2014-11-30

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