The invention provides unit dosage forms, kits, and methods and useful for treating viral infections.

The invention provides unit dosage forms, kits, and methods and useful for treating viral infections.

The present invention relates to methods for treating diseases or conditions in which proprotein convertase subtilisin/kexin type 9 (PCSK9) expression or activity causes an impact by administration of PCSK9-specific antibodies or antigen-binding fragments thereof and preferably by additional administration of an inhibitor of 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase). The present invention further relates to PCSK9-specific antibodies or antigen-binding fragments thereof for use in the treatment of diseases or conditions in which PCSK9 expression or activity causes an impact. The present invention also relates to articles of manufacture comprising packaging material, PCSK9-specific antibodies or antigen-binding fragments thereof, and a label or packaging insert indicating which groups of patients can be treated with said antibodies or fragments, which groups of patients must not be treated with said antibodies or fragments, and which dosage regimen should be used. The present invention further relates to methods of testing the efficacy of PCSK9-specific antibodies or antigen-binding fragments thereof for the treatment of certain diseases or conditions and for the treatment of specific sub-groups of patients.

A compound of formula (I) wherein n is 0 to 4; m is 0 or 1 with the proviso that the sulphur atom and R.sub.3 are in vicinal position (if m=0 then R.sub.3 is in position 2′, and if m=1 then R.sup.3 is on position 1′); R is ethyl or vinyl; R.sub.1 is hydrogen or (C1-6)alkyl; R.sub.2 is hydrogen or—(C.sub.3-6)cycloalkyl, or—unsubstituted (C.sub.1-6)alkyl, or—(C.sub.1-6)alkyl substituted by one or more of—hydroxy; preferably one or two,—methoxy,—halogen,—(C.sub.3-6)cycloalkyl, or R.sub.1 and R.sub.2 together with the nitrogen atom to which they are attached form a 5 to 7 membered heterocyclic ring containing at least 1 nitrogen atom or 1 nitrogen and 1 additional heteroatome e. g. selected from N or O, or R.sub.1 is hydroxy and R.sub.2 is formyl; R.sub.3 is OH, OR.sub.4, a halogen atom, or—with the proviso that R.sub.3 is bound to 2′ R.sub.3 represents —O—(CH.sub.2)P—O— with p is 2 or 3; R.sub.4 is unsubstituted (C.sub.1-6)alkyl or (C.sub.3-6)cycloalkyl.

A compound of formula (I) wherein n is 0 to 4; m is 0 or 1 with the proviso that the sulphur atom and R.sub.3 are in vicinal position (if m=0 then R.sub.3 is in position 2′, and if m=1 then R.sup.3 is on position 1′); R is ethyl or vinyl; R.sub.1 is hydrogen or (C1-6)alkyl; R.sub.2 is hydrogen or—(C.sub.3-6)cycloalkyl, or—unsubstituted (C.sub.1-6)alkyl, or—(C.sub.1-6)alkyl substituted by one or more of—hydroxy; preferably one or two,—methoxy,—halogen,—(C.sub.3-6)cycloalkyl, or R.sub.1 and R.sub.2 together with the nitrogen atom to which they are attached form a 5 to 7 membered heterocyclic ring containing at least 1 nitrogen atom or 1 nitrogen and 1 additional heteroatome e. g. selected from N or O, or R.sub.1 is hydroxy and R.sub.2 is formyl; R.sub.3 is OH, OR.sub.4, a halogen atom, or—with the proviso that R.sub.3 is bound to 2′ R.sub.3 represents —O—(CH.sub.2)P—O— with p is 2 or 3; R.sub.4 is unsubstituted (C.sub.1-6)alkyl or (C.sub.3-6)cycloalkyl.

Drug delivery devices comprising a non-bioabsorbable polymer structure configured to support a composition comprising an active agent. The devices include a plurality of portions fused together and a recess configured to support the composition. At least one of the portions includes an impermeable polymer and at least one other portion includes a rate-limiting water-permeable polymer. The rate-limiting water-permeable polymer allows for transportation of the active agent to an exterior of the device.

Drug delivery devices comprising a non-bioabsorbable polymer structure configured to support a composition comprising an active agent. The devices include a plurality of portions fused together and a recess configured to support the composition. At least one of the portions includes an impermeable polymer and at least one other portion includes a rate-limiting water-permeable polymer. The rate-limiting water-permeable polymer allows for transportation of the active agent to an exterior of the device.

Provided herein are gel formulations of acyclovir with a low concentration of acyclovir, which can be used, for example, for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. The gel formulation can be an aqueous gel formulation, an emulsified gel formulation, or a non-aqueous gel formulation.

Provided herein are compositions for the treatment and/or prevention of cardiovascular disease (CVD), and methods of application and use thereof. In particular, the present invention provides treatment and/or prevention of cardiovascular disease with compounds that inhibit the production of TMA in the gut, such as 3,3-dimethyl-1-butanol (DMB) or other compounds represented by Formula I or as shown in FIGS. 20-23.

Provided herein are compositions for the treatment and/or prevention of cardiovascular disease (CVD), and methods of application and use thereof. In particular, the present invention provides treatment and/or prevention of cardiovascular disease with compounds that inhibit the production of TMA in the gut, such as 3,3-dimethyl-1-butanol (DMB) or other compounds represented by Formula I or as shown in FIGS. 20-23.