Viral prophylaxis treatment methods and pre-exposure prophylaxis kits

1. A method of preventing herpes simplex virus (HSV) infection in a subject in need thereof, the method comprising orally administering to the subject a pharmaceutical composition 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);

wherein the subject is HSV seronegative, the preventing is pre-exposure prophylaxis against HSV infection, and whereby the risk of HSV infection in the subject is reduced.

2. The method of claim 1 , wherein the pharmaceutical composition comprises 0.5 mg/kg body weight to about 100 mg/kg body weight of (a) and 0.5 mg/kg body weight to about 100 mg/kg body weight of (b).

3. The method of claim 1 , wherein the pharmaceutical composition comprises about 1 mg to about 5000 mg of valacyclovir or a salt or solvate thereof and about 1 mg to about 5000 mg famciclovir or a salt or solvate thereof.

4. The method of claim 1 , wherein the pharmaceutical composition comprises about 250 mg to about 1000 mg of valacyclovir or a salt or solvate thereof and about 250 mg to about 1000 mg famciclovir or a salt or solvate thereof.

5. The method of claim 1 , wherein the pharmaceutical composition is formulated for oral administration.

6. The method of claim 1 , wherein the pharmaceutical composition comprises an oral tablet, oral capsule, or oral solution.

7. The method of claim 1 , comprising administration of the pharmaceutical composition once daily or twice daily.

8. The method of claim 1 , wherein the pharmaceutical composition is formulated in sustained-release form.

9. The method of claim 1 , comprising parenteral or intravenous administration of the pharmaceutical composition.

10. The method of claim 1 , additionally comprising administering a therapeutically effective amount of an HIV antiviral agent.

11. The method of claim 1 , wherein the subject is a female and the method additionally comprises administering a therapeutically effective amount of a contraceptive.

12. The method of claim 1 , wherein the method additionally comprises administering a therapeutically effective amount of an additional antiviral agent.

13. The method of claim 12 , wherein the additional antiviral agent comprises a helicase-primase inhibitor, tenofovir, emtricitabine, lamivudine, interfereon, ribavirin, boceprevir, telaprevir, simeprevir, sofosbuvir, ledipasvir, ombitasvir, paritaprevir, pritelivir, brincidofovir, cidofovir, ganciclovir, valganciclovir, or ritonavir.

14. The method of claim 1 , wherein (a) comprises valacyclovir and (b) comprises famciclovir.

15. The method of claim 1 , wherein the administering begins after physical contact with a partner who is seropositive for HSV.

16. The method of claim 1 , wherein the administering begins prior to physical contact with an HSV seropositive partner.

17. The method of claim 16 , further comprising administering the composition to the HSV seropositive partner.

18. The method of claim 1 , wherein the HSV is HSV-1, HSV-2, varicella-zoster (chicken pox, shingles, human herpes virus 3), 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).

19. The method of claim 1 , wherein the pharmaceutical composition comprises about 750 mg valacyclovir or a salt or solvate thereof and about 200 mg famciclovir or a salt or solvate thereof.

20. The method of claim 1 , wherein the pharmaceutical composition comprises about 250 mg to about 1500 mg valacyclovir or a salt or solvate thereof and about 60 mg to about 400 mg famciclovir.

21. The method of claim 19 , wherein the pharmaceutical composition is formulated for oral administration.

22. The method of claim 19 , wherein the pharmaceutical composition comprises an oral tablet.

23. The method of claim 22 , wherein the oral tablet is formulated for immediate-release of the valacyclovir and the famciclovir.

24. The method of claim 20 , wherein the pharmaceutical composition is formulated for oral administration.

25. The method of claim 20 , wherein the pharmaceutical composition comprises an oral tablet.

26. The method of claim 25 , wherein the oral tablet is formulated for immediate-release of the valacyclovir and the famciclovir.

27. The method of claim 11 , wherein the contraceptive comprises levonorgestrel, estradiol, dosogestrel, ethinyl, estradiol, norethindrone acetate, norgestimate, or salts, solvates or combinations thereof.

28. The method of claim 27 , wherein the contraceptive agent comprises levonorgestrel and estradiol.

29. The method of claim 28 , wherein the HSV seronegative subject is administered about 0.10 mg of levonorgestrel and about 0.02 mg of estradiol.

30. The method of claim 11 , wherein the contraceptive agent comprises dosogestrel and ethinyl estradiol.

31. The method of claim 30 , wherein the HSV seronegative subject is administered about 0.15 mg of dosogestrel and about 0.03 mg of ethinyl estradiol.

32. The method of claim 11 , wherein the contraceptive agent comprises norethindrone acetate and ethinyl estradiol.

33. The method of claim 32 , wherein the HSV seronegative subject is administered about 1 mg of norethindrone acetate and about 20 μg of ethinyl estradiol.

34. The method of claim 11 , wherein the contraceptive agent comprises norgestimate and ethinyl estradiol.

35. The method of claim 34 , wherein the HSV seronegative subject is administered about 0.18 mg or about 0.25 mg of norgestimate and about 35 μg or 25 μg of ethinyl estradiol.

36. The method of claim 12 , wherein the additional antiviral agent is lamivudine.

37. The method of claim 36 , wherein the subject is administered about 50 mg to about 400 mg of lamivudine.

38. The method of claim 16 , wherein the physical contact occurs during one sexual incident.

39. The method of claim 16 , wherein the physical contact occurs during two or more sexual incidents.

40. The method of claim 16 , wherein the pharmaceutical composition is not administered to an HSV seropositive partner.

41. The method of claim 1 , wherein the HSV is HSV-1.

42. The method of claim 1 , wherein the HSV is HSV-2.