Claims for Patent: 4,829,055

Summary for Patent: 4,829,055

Title:	Method of treatment for herpes infections of external tissues
Abstract:	A method of treatment is disclosed for herpes infections of external tissues and method of preventing the occurrence of blisters and ulcerations in herpes disease in humans. The method consists of directly injecting small treatment amounts of suitable antiviral agents, e.g., acyclovir, ribavirin, or vidarabine (ara-A), within the specific time period of first 36 hours after the appearance of detectable manifestations of external-tissue infection or any of the prodromal symptoms of burning pain, itching, tingling, swelling and erythema or combinations thereof. The treatment amounts of antiviral drugs per day used in this invention are very small compared to the dosage amounts used by prior art calculated based on kilograms of body weight per day. The antiviral drugs so injected will kill the virus quickly in the skin or mucus membrane, or inhibit its replication or otherwise render the virus inactive before the virus will have time to multiply and form the blisters and ulcerations.
Inventor(s):	Naficy; Sadeque S. (Houston, TX)
Assignee:
Application Number:	07/006,478
Patent Claims:	1. A method of treatment for herpes infections of external tissues including skin and mucus membrane in humans, comprising the steps of injecting or infiltrating, small doses, in an effective amount in the range of 1 ml to 10 ml of a solution of an antiviral drug effective in the treatment of herpes virus having a concentration of 0.01 mg/ml to 10 mg/ml only in and around said areas of infetion of external tissues; said injection or infiltration being administered in 1 to 6 injections at 2-4 hour intervals, as needed, during the specific time period of first 36 hours after the appearance of detectable manifestations of infections of said external tissues; said treatment amounts of said antiviral drugs being just sufficient to provide effective therapeutic concentrations in said infected external tissues; without producing a steady state of therapeutic levels of antiviral agents in the serum or blood or other tissues; and thus using necessary treatment amounts of said antiviral drugs per day substantially less than conventional dosage amounts per day calculated based on kilograms of body weight. 2. A method according to claim 1 wherein said herpes infections are caused by herpes simplex virus type 1 (HSV-1) or herpes simplex virus type 2 (HSV-2) or varicella-zoster virus. 3. A method according to claim 1 wherein said anti-viral drug or agent is acyclovir, ribavirin, or vidarabine (ara-A). 4. A method of preventing the occurrence of herpes lesions and ulcerations of external tissues including skin and mucus membrane, comprising the steps of injecting or infiltrating small doses, in an effective amount in the range of 1 ml to 10 ml of a solution of an antiviral drug effective in the treatment of herpes virus having a concentration of 0.01 mg/ml to 10 mg/ml in the substance of skin and mucus membrane or under the skin and mucus membrane; said treatment amounts being administered only in and around the areas of skin and mucus membrane showing the prodromal symptoms, or early detectable manifestations of external tissue-infection and impending lesions, consisting predominantly of itching, pain, swelling, erthema, tingling and burning sensation, or combinations thereof; said injections or infiltrations being administered in 1 to 6 injections at 2-4 hour intervals, as needed, during the specicic time period of first 36 hours after the appearance of any of said prodromal symptoms, and in treatment amounts of said antiviral drugs just sufficient to provide effective therapeutic concentrations in said infected external tissues without producing a steady state of therapeutic level of antiviral drugs in the serum or blood or other tissues; whereby the necessary treatment amounts of said antiviral drugs per day being far less than conventional dosage amounts per day calculated based on kilograms of body weight. 5. A method of treatment according to claim 4 in which said antiviral drug is acyclovir, ribavirin, or vidarabine (Ara-A). 6. A method of treatment according to claim 5 wherein the antiviral drug is acyclovir. 7. A method of treatment according to claim 5 wherein the antiviral drug is ribavirin. 8. A method of treatment according to claim 5 wherein the antiviral drug is vidarabine (ara-A).

Details for Patent 4,829,055

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	PEGASYS COPEGUS COMBINATION PACK	peginterferon alfa-2a and ribavirin		125083	June 04, 2004	4,829,055	2039-03-29
Schering Corporation A Subsidiary Of Merck & Co., Inc.	PEGINTRON/ REBETOL COMBO PACK	peginterferon alfa-2b and ribavirin		125196	June 13, 2008	4,829,055	2039-03-29