US2023310439A1PendingUtilityA1
Viral prophylaxis treatment methods and pre-exposure prophylaxis kits
Est. expiryFeb 25, 2039(~12.6 yrs left)· nominal 20-yr term from priority
A61K 31/522A61P 31/22A61K 9/0036A61K 9/7023A61K 31/52A61K 45/06A61K 2300/00
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Claims
Abstract
The present disclosure provides compositions and methods for the prevention of HSV infection in an HSV seronegative individual and for the treatment and prevention of recurrence in an HSV seropositive individual.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1 . A pharmaceutical composition for treatment of herpes simplex virus (HSV) infection, prophylaxis, or pre-exposure prophylaxis against HSV infection in a subject in need thereof comprising: a therapeutically effective amount of (a) valacyclovir or a salt or solvate thereof and (b) famciclovir or a salt or solvate thereof; and pharmaceutically acceptable excipient(s), diluent(s), carrier(s) and/or adjuvant(s).
2 . The pharmaceutical composition of claim 1 , comprising 0.5 mg/kg body weight to about 1000 mg/kg body weight of (a) and 0.5 mg/kg body weight to about 1000 mg/kg body weight of (b).
3 . The pharmaceutical composition of claim 2 , comprising about 5 mg/kg body weight to about 50 mg/kg body weight of (a).
4 . The pharmaceutical composition of claim 2 , comprising about 25 mg/kg body weight to about 100 mg/kg body weight of (a).
5 . The pharmaceutical composition of claim 2 , comprising about 50 mg/kg body weight to about 250 mg/kg body weight of (a).
6 . The pharmaceutical composition of claim 2 , comprising about 100 mg/kg body weight to about 500 mg/kg body weight of (a).
7 . The pharmaceutical composition of any one of claims 2 to 6 , comprising about 5 mg/kg body weight to about 50 mg/kg body weight of (b).
8 . The pharmaceutical composition of any one of claims 2 to 6 , comprising about 25 mg/kg body weight to about 100 mg/kg body weight of (b).
9 . The pharmaceutical composition of any one of claims 2 to 6 , comprising about 50 mg/kg body weight to about 250 mg/kg body weight of (b).
10 . The pharmaceutical composition of any one of claims 2 to 6 , comprising about 100 mg/kg body weight to about 500 mg/kg body weight of (b).
11 . The pharmaceutical composition of claim 2 , comprising (a) and (b) in a dose ratio in mg/kg of about 5:1, about 4:1, about 3:1, about 2:1, about 1:1, about 1:2, about 1:3, about 1:4, or about 1:5.
12 . The pharmaceutical composition of claim 2 , comprising about 5 mg/kg body weight to about 15 mg/kg body weight of (a) and about 2.5 mg/kg body weight to about 7.5 mg/kg body weight of (b).
13 . The pharmaceutical composition of claim 2 , comprising about 10 mg/kg body weight to about 50 mg/kg body weight of (a) and about 5 mg/kg body weight to about 25 mg/kg body weight of (b).
14 . The pharmaceutical composition of claim 2 , comprising about 50 mg/kg body weight to about 150 mg/kg body weight of (a) and about 20 mg/kg body weight to about 50 mg/kg body weight of (b).
15 . The pharmaceutical composition of claim 2 , comprising about 100 mg/kg body weight to about 150 mg/kg body weight of (a) and about 50 mg/kg body weight to about 100 mg/kg body weight of (b).
16 . The pharmaceutical composition of claim 2 , comprising about 150 mg/kg body weight to about 500 mg/kg body weight of (a) and about 100 mg/kg body weight to about 250 mg/kg body weight of (b).
17 . The pharmaceutical composition of claim 2 , comprising about 250 mg/kg body weight to about 1000 mg/kg body weight of (a) and about 150 mg/kg body weight to about 500 mg/kg body weight of (b).
18 . The pharmaceutical composition of claim 2 , comprising from greater than 100 mg/kg to about 700 mg/kg body weight of valacyclovir and from greater than 100 mg/kg to about 500 mg/kg body weight of famciclovir.
19 . The pharmaceutical composition of any one of claims 1 to 18 , comprising about 1 mg to about 8000 mg of valacyclovir or a salt or solvate thereof and about 1 mg to about 8000 mg famciclovir or a salt or solvate thereof.
20 . The pharmaceutical composition of any one of claims 1 to 18 , comprising about 125 mg to about 2000 mg of valacyclovir or a salt or solvate thereof and about 60 mg to about 1000 mg famciclovir or a salt or solvate thereof.
21 . The pharmaceutical composition of any one of claims 1 to 20 , formulated for oral administration.
22 . The pharmaceutical composition of claim 21 , comprising an oral tablet, oral capsule, or oral solution.
23 . The pharmaceutical composition of any one of claims 1 to 20 , formulated for administration once daily or twice daily.
24 . The pharmaceutical composition of any one of claims 1 to 20 , formulated in sustained-release form.
25 . The pharmaceutical composition of any one of claims 1 to 20 , formulated in parenteral administration form.
26 . The pharmaceutical composition of any one of claims 1 to 20 , additionally comprising a therapeutically effective amount of an HIV antiviral agent.
27 . The pharmaceutical composition of any one of claims 1 to 20 , formulated for a female and additionally comprising a therapeutically effective amount of a contraceptive.
28 . The pharmaceutical composition of any one of claims 1 to 20 , additionally comprising a therapeutically effective amount of an additional antiviral agent.
29 . The pharmaceutical composition of claim 28 , wherein the additional antiviral agent comprises a helicase-primase inhibitor, amenamevir, N-methancocarbathymidine (N-MCT), tenofovir, emtricitabine, lamivudine, interfereon, ribavirin, boceprevir, telaprevir, simeprevir, sofosbuvir, ledipasvir, tenofovir, ombitasvir, paritaprevir, penciclovir, pritelivir, brincidofovir, cidofovir, ganciclovir, valganciclovir, valomaciclovir, or ritonavir.
30 . The pharmaceutical composition of any one of claims 1 to 20 , wherein the HSV is HSV-1, HSV-2, varicella-zoster virus (VZV), Epstein-Barr virus (human herpes virus 4), cytomegalovirus (human herpes virus 5), roseolovirus (human herpes virus 6 and 7), or Karposi's sarcoma-associated herpes virus (human herpes virus 8).
31 . The pharmaceutical composition of claim 30 , wherein the HSV is HSV-2.
32 . The pharmaceutical composition of claim 30 , wherein the HSV is VZV.
33 . A pharmaceutical composition for treatment of herpes simplex virus (HSV) infection, prophylaxis, or pre-exposure prophylaxis against HSV infection in a subject in need thereof comprising: a therapeutically effective amount of greater than 100 mg/kg body weight of an antiviral agent comprising acyclovir or a salt or solvate thereof, or valacyclovir or a salt or solvate thereof, or famciclovir or a salt or solvate thereof, or combinations thereof, whereby the risk of HSV infection in the subject is reduced.
34 . The pharmaceutical composition of claim 33 , wherein the amount of the antiviral agent is from greater than 100 mg/kg to about 1000 mg/kg body weight.
35 . The pharmaceutical composition of claim 33 , wherein the amount of the antiviral agent is from greater than 100 mg/kg to about 700 mg/kg body weight.
36 . The pharmaceutical composition of claim 33 , wherein the amount of the antiviral agent is from greater than 100 mg/kg to about 500 mg/kg body weight.
37 . The pharmaceutical composition of claim 33 , wherein the amount of the antiviral agent is from greater than 100 mg/kg to about 250 mg/kg body weight.
38 . The pharmaceutical composition of claim 33 , wherein the amount of the antiviral agent is from about 125 mg/kg to about 500 mg/kg body weight.
39 . The pharmaceutical composition of claim 33 , wherein the antiviral agent comprises valacyclovir or a salt or solvate thereof.
40 . The pharmaceutical composition of claim 33 , wherein the antiviral agent comprises famciclovir or a salt or solvate thereof.
41 . The pharmaceutical composition of claim 33 , wherein the antiviral agent comprises acyclovir or a salt or solvate thereof.
42 . The pharmaceutical composition of claim 33 , which comprises 0.5 mg/kg to about 1000 mg/kg body weight of a second antiviral agent.
43 . The pharmaceutical composition of claim 33 , which comprises 0.5 mg/kg to about 700 mg/kg body weight of a second antiviral agent.
44 . The pharmaceutical composition of claim 33 , which comprises 0.5 mg/kg to about 500 mg/kg body weight of a second antiviral agent.
45 . The pharmaceutical composition of claim 33 , which comprises greater than about 100 mg/kg body weight of a second antiviral agent.
46 . The pharmaceutical composition of claim 33 , which comprises valacyclovir or a salt or solvate thereof and famciclovir or a salt or solvate thereof.
47 . The pharmaceutical composition of claim 33 , which comprises valacyclovir or a salt or solvate thereof and acyclovir or a salt or solvate thereof.
48 . The pharmaceutical composition of claim 46 , which comprises greater than 100 mg/kg body weight of valacyclovir and greater than 100 mg/kg body weight of famciclovir.
49 . The pharmaceutical composition of claim 46 , which comprises from greater than 100 mg/kg to about 700 mg/kg body weight of valacyclovir and from greater than 100 mg/kg to about 500 mg/kg body weight of famciclovir.
50 . The pharmaceutical composition of claim 48 , comprising about 1 mg to about 8000 mg of valacyclovir or a salt or solvate thereof and about 1 mg to about 8000 mg famciclovir or a salt or solvate thereof.
51 . The pharmaceutical composition of claim 48 , comprising about 125 mg to about 2000 mg of valacyclovir or a salt or solvate thereof and about 60 mg to about 1000 mg famciclovir or a salt or solvate thereof.
52 . The pharmaceutical composition of claim 46 , formulated for oral administration.
53 . The pharmaceutical composition of claim 52 , comprising an oral tablet, oral capsule, or oral solution.
54 . The pharmaceutical composition of claim 46 , formulated for administration once daily or twice daily.
55 . The pharmaceutical composition of claim 46 , formulated in sustained-release form.
56 . The pharmaceutical composition of claim 46 , formulated in parenteral administration form.
57 . The pharmaceutical composition of claim 46 , additionally comprising a therapeutically effective amount of an HIV antiviral agent.
58 . The pharmaceutical composition of claim 46 , formulated for a female and additionally comprising a therapeutically effective amount of a contraceptive.
59 . The pharmaceutical composition of claim 46 , additionally comprising a therapeutically effective amount of an additional antiviral agent.
60 . The pharmaceutical composition of claim 59 , wherein the additional antiviral agent comprises a helicase-primase inhibitor, amenamevir, N-methancocarbathymidine (N-MCT), tenofovir, emtricitabine, lamivudine, interfereon, ribavirin, boceprevir, telaprevir, simeprevir, sofosbuvir, ledipasvir, tenofovir, ombitasvir, paritaprevir, penciclovir, pritelivir, brincidofovir, cidofovir, ganciclovir, valganciclovir, valomaciclovir, or ritonavir.
61 . The pharmaceutical composition of claim 33 , wherein the HSV is HSV-1, HSV-2, varicella-zoster (VZV), Epstein-Barr virus (human herpes virus 4), cytomegalovirus (human herpes virus 5), roseolovirus (human herpes virus 6 and 7), or Karposi's sarcoma-associated herpes virus (human herpes virus 8).
62 . The pharmaceutical composition of claim 61 , wherein the HSV is HSV-2.
63 . A method of pre-exposure prophylaxis against HSV infection in an HSV seronegative subject in need thereof, or a method of treating an HSV infection, or a method of suppressing an HSV infection, or a method of treatment or prophylactic treatment of a disease or condition associated with HSV infection, the method comprising administering to the subject daily a therapeutically effective amount of (a) valacyclovir or a salt or solvate thereof and (b) famciclovir or a salt or solvate thereof; and pharmaceutically acceptable excipient(s), diluent(s), carrier(s) and/or adjuvant(s).
64 . The method of claim 63 , wherein the therapeutically effective amount comprises 0.5 mg/kg body weight to about 1000 mg/kg body weight of (a) and 0.5 mg/kg body weight to about 1000 mg/kg body weight of (b).
65 . The method of claim 64 , wherein the therapeutically effective amount comprises about 5 mg/kg body weight to about 50 mg/kg body weight of (a).
66 . The method of claim 64 , wherein the therapeutically effective amount comprises about 25 mg/kg body weight to about 100 mg/kg body weight of (a).
67 . The method of claim 64 , wherein the therapeutically effective amount comprises about 50 mg/kg body weight to about 250 mg/kg body weight of (a).
68 . The method of claim 64 , wherein the therapeutically effective amount comprises about 100 mg/kg body weight to about 500 mg/kg body weight of (a).
69 . The method of any one of claims 64 to 68 , wherein the therapeutically effective amount comprises about 5 mg/kg body weight to about 50 mg/kg body weight of (b).
70 . The method of any one of claims 64 to 68 , wherein the therapeutically effective amount comprises about 25 mg/kg body weight to about 100 mg/kg body weight of (b).
71 . The method of any one of claims 64 to 68 , wherein the therapeutically effective amount comprises about 50 mg/kg body weight to about 250 mg/kg body weight of (b).
72 . The method of any one of claims 64 to 68 , wherein the therapeutically effective amount comprises about 100 mg/kg body weight to about 500 mg/kg body weight of (b).
73 . The method of claim 64 , wherein the therapeutically effective amount comprises (a) and (b) in a dose ratio in mg/kg of about 5:1, about 4:1, about 3:1, about 2:1, about 1:1, about 1:2, about 1:3, about 1:4, or about 1:5.
74 . The method of claim 64 , wherein the therapeutically effective amount about 50 mg/kg body weight to about 150 mg/kg body weight of (a) and about 20 mg/kg body weight to about 50 mg/kg body weight of (b).
75 . The method of claim 64 , wherein the therapeutically effective amount about 100 mg/kg body weight to about 150 mg/kg body weight of (a) and about 50 mg/kg body weight to about 100 mg/kg body weight of (b).
76 . The method of claim 64 , wherein the therapeutically effective amount about 150 mg/kg body weight to about 500 mg/kg body weight of (a) and about 100 mg/kg body weight to about 250 mg/kg body weight of (b).
77 . The method of claim 64 , wherein the therapeutically effective amount about 250 mg/kg body weight to about 1000 mg/kg body weight of (a) and about 150 mg/kg body weight to about 500 mg/kg body weight of (b).
78 . The method of claim 64 , wherein the HSV infection is a neonatal infection.
79 . The method of claim 64 , wherein the disease or infection associated with HSV infection is Alzheimer's disease.
80 . A method of pre-exposure prophylaxis against herpes simplex virus (HSV) infection in an HSV seronegative subject in need thereof, or a method of treating an HSV infection, or a method of suppressing an HSV infection, or a method of treatment or prophylactic treatment of a disease or condition associated with HSV infection, the method comprising administering to the subject daily a therapeutically effective amount of greater than 100 mg/kg body weight of an antiviral agent comprising acyclovir or a salt or solvate thereof, or valacyclovir or a salt or solvate thereof, or famciclovir or a salt or solvate thereof, or combinations thereof, whereby the risk of HSV infection in the subject is reduced.
81 . The method of claim 80 , wherein the amount of the antiviral agent is from greater than 100 mg/kg to about 1000 mg/kg body weight.
82 . The method of claim 80 , wherein the amount of the antiviral agent is from greater than 100 mg/kg to about 700 mg/kg body weight.
83 . The method of claim 80 , wherein the amount of the antiviral agent is from greater than 100 mg/kg to about 500 mg/kg body weight.
84 . The method of claim 80 , wherein the amount of the antiviral agent is from greater than 100 mg/kg to about 250 mg/kg body weight.
85 . The method of claim 80 , wherein the amount of the antiviral agent is from about 125 mg/kg to about 500 mg/kg body weight.
86 . The method of claim 80 , wherein the antiviral agent comprises valacyclovir or a salt or solvate thereof.
87 . The method of claim 80 , wherein the antiviral agent comprises famciclovir or a salt or solvate thereof.
88 . The method of claim 80 , wherein the antiviral agent comprises acyclovir or a salt or solvate thereof.
89 . The method of claim 80 , which comprises administering 0.5 mg/kg to about 1000 mg/kg body weight of a second antiviral agent.
90 . The method of claim 80 , which comprises administering 0.5 mg/kg to about 700 mg/kg body weight of a second antiviral agent.
91 . The method of claim 80 , which comprises administering 0.5 mg/kg to about 500 mg/kg body weight of a second antiviral agent.
92 . The method of claim 80 , which comprises administering greater than about 100 mg/kg body weight of a second antiviral agent.
93 . The method of claim 80 , wherein the antiviral agent comprises valacyclovir or a salt or solvate thereof and famciclovir or a salt or solvate thereof.
94 . The method of claim 80 , wherein the antiviral agent comprises valacyclovir or a salt or solvate thereof and acyclovir or a salt or solvate thereof.
95 . The method of claim 93 , wherein the antiviral agent comprises greater than 100 mg/kg body weight of valacyclovir and greater than 100 mg/kg body weight of famciclovir.
96 . The method of claim 93 , wherein the antiviral agent comprises greater than 100 mg/kg to about 700 mg/kg body weight of valacyclovir and greater than 100 mg/kg to about 500 mg/kg body weight of famciclovir.
97 . The method of claim 93 , which comprises administering about 1 mg to about 8000 mg of valacyclovir or a salt or solvate thereof and about 1 mg to about 8000 mg of famciclovir or a salt or solvate thereof.
98 . The method of claim 93 , which comprises administering about 125 mg to about 2000 mg of valacyclovir or a salt or solvate thereof and about 60 mg to about 1000 mg of famciclovir or a salt or solvate thereof.
99 . The method of claim 80 , wherein the administering is oral or intravenous.
100 . The method of claim 80 , wherein the administering is once daily or twice daily.
101 . The method of claim 80 , wherein the administering begins after physical contact with a partner who is seropositive for HSV.
102 . The method of claim 80 , wherein the administering begins prior to physical contact with the HSV seropositive partner.
103 . The method of claim 80 , comprising administering the composition to the HSV seropositive partner.
104 . The method of claim 80 , wherein the HSV is HSV-1, HSV-2, varicella-zoster virus (VZV), Epstein-Barr virus (human herpes virus 4), cytomegalovirus (human herpes virus 5), roseolovirus (human herpes virus 6 and 7), or Karposi's sarcoma-associated herpes virus (human herpes virus 8).
105 . The method of claim 104 , wherein the HSV is HSV-2.
106 . The method of claim 104 , wherein the HSV is VZV.
107 . The method of claim 80 , wherein the HSV infection is a neonatal infection.
108 . The method of claim 80 , wherein the disease or infection associated with HSV infection is Alzheimer's disease.Join the waitlist — get patent alerts
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