Valacyclovir
Treatment for Genital Herpes
Typical Dosage: Episodic: 1g 2x/day for 1 day; Suppressive: 500mg-1g 1x/day
Effectiveness
88%
Safety Score
77%
Clinical Trials
33
Participants
40K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
77
DangerousModerateSafe
Treatment Details
Dosage Range
Episodic: 1g 2x/day for 1 day; Suppressive: 500mg-1g 1x/day
Time to Effect
Days to weeks
Treatment Duration
Episodic: 1-3 days; Suppressive: 6-12 months to indefinite
Evidence Quality
HIGHNumber Needed to Treat (NNT)
2(Treat 2 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
500(Treat 500 patients to see 1 additional serious adverse event)
Confidence Score
95%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$350
Monitoring:$150
Side Effect Mgmt:$50
Total Annual:$550
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
EXCELLENTICER
$15,000/QALY
QALYs Gained
0.06
Outcome-Based Costs
Cost per Responder
$647
Cost per Remission
$786
Comparison vs Acyclovir
Cost Difference
+$50/year
More expensive
QALY Difference
+0.01 QALYs
Better outcomes
Dominance
No dominance
Prescription Access Economics
Annual Societal Loss per Patient
$200
Cost of prescription-only barriers (visits, time, admin, price premium)
Physician Visit Cost
$150/year
Time Cost
$30/year
Travel + wait time
Insurance Admin Cost
$20/year
Prior auth, claims
Rx Price
$350/year
Potential OTC Price
$120/year
Estimated if OTC available
Risk Assessment
Misuse Risk
LOWMissed Diagnosis Risk
MODERATEValacyclovir Outcomes
for Genital Herpes
Efficacy Outcomes
Overall Effectiveness
+88%
Response Rate
+85%
Remission Rate
+70%
Common Side Effects
Headache
+30%
Nausea
+10%
Abdominal pain
+5%
Diarrhea
+5%
Sources:
Active Clinical Trials
No active trials currently recruiting for this treatment
No active trials found in ClinicalTrials.gov
Completed Clinical Trials
17 completed trials for Valacyclovir in Genital Herpes
Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
NCT01346475COMPLETEDPHASE4
50 participants
INTERVENTIONAL
Seattle, United States
Started: Nov 1, 2008
Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)
NCT01390805COMPLETED
462 participants
OBSERVATIONAL
Started: Nov 1, 2006
Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection
NCT04165122COMPLETEDPHASE2
122 participants
INTERVENTIONAL
Berlin, Germany +7 more
Started: Nov 15, 2019
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
NCT00306787COMPLETEDPHASE3
1.18K participants
INTERVENTIONAL
Birmingham, United States +65 more
Started: Mar 1, 2006
Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
NCT00362297COMPLETEDPHASE4
31 participants
INTERVENTIONAL
Seattle, United States
Started: Sep 1, 2006
A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.
NCT00158860COMPLETEDPHASE4
384 participants
INTERVENTIONAL
Birmingham, United States +71 more
Started: Jun 21, 2004
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions
NCT01132716COMPLETEDNA
48 participants
INTERVENTIONAL
Fargo, United States
Started: Sep 1, 2006
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
NCT01132729COMPLETEDNA
48 participants
INTERVENTIONAL
Fargo, United States
Started: Sep 1, 2006
Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel
NCT04664127COMPLETED
45 participants
OBSERVATIONAL
Moscow, Russia
Started: Oct 30, 2017
A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
NCT00486200COMPLETEDPHASE2
695 participants
INTERVENTIONAL
Birmingham, United States +24 more
Started: Jun 21, 2007
Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV
NCT00527618COMPLETEDPHASE4
28 participants
INTERVENTIONAL
Seattle, United States
Started: Dec 1, 2007
Randomised Controlled Trial Assessing the Impact of Genital Herpes Suppressive Therapy on HIV Shedding
NCT00158509COMPLETEDPHASE2
215 participants
INTERVENTIONAL
Bobo-Dioulasso, Burkina Faso
Started: Aug 1, 2004
VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2
NCT00306293COMPLETEDPHASE4
70 participants
INTERVENTIONAL
Anaheim, United States +17 more
Started: Feb 20, 2006
HSV529 Vaccine in HSV-2 Seropositive Adults
NCT02571166COMPLETEDPHASE1
10 participants
INTERVENTIONAL
Seattle, United States
Started: Nov 1, 2015
The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients
NCT00002404COMPLETEDNA
30 participants
INTERVENTIONAL
Valaciclovir to Prevent Transmission of Herpes Simplex Virus
NCT00001649COMPLETEDPHASE3
180 participants
INTERVENTIONAL
Bethesda, United States
Started: Aug 1, 1997
Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons
NCT01026454COMPLETEDPHASE4
32 participants
INTERVENTIONAL
Thika, Kenya
Started: Feb 1, 2010
Showing 20 of 33 total trials