Industry Request Integrase Inhibitors

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Transcription:

Industry Request Integrase Inhibitors The objective of this request is to describe and understand the temporal changes in the prescribing practices of Integrese Inibitors (II) in AHOD cohort between 1/1/ and 31/12/. The information found in this document will be used to assist planning of educational initiatives and communication of the use of II s. NOTE: the following points are applicable throughout the document unless clearly stated otherwise. 1. A patient s regimen is classified* by selecting the combination antiretroviral therapy regimen with the longest duration in each calendar year. lost to follow- up before 1/1/ or off- treatment are not included in results presented in this document. *the classification of a regimen is based on the individual agents of the regimen. The following classifications are used in AHOD. Antiretroviral agent class definition: II Integrase Inhibitor NRTI Nucleoside/Nucleotide reverse transcriptase inhibitor NNRTI Non- nucleoside reverse transcriptase inhibitor PI Protease inhibitor MONO mono therapy DUO dual therapy Label II NNRTI+PI NRTI NRTI+NNRTI NRTI+PI MONO/DUO Description 3+ agents, II, (±NRTI ±NNRTI ±PI) 3+ agents, NNRTI+PI, (±NRTI, no II) 3+ agents, NRTI (no NNRTI, no PI, no II) 3+ agents, NRTI+NNRTI (no PI, no II) 3+ agents, NRTI+PI (no NNRTI, no II) 1 or 2 agents used individually or together 2. Combination antiretroviral therapy (cart) regimens are defined as 3 or more antiretroviral agents initiated after 1/1/1997 and have a duration of usage more than 14 days. 3. lines (1 st, 2 nd, 3 rd, 4 th +) are defined by any change to the original cart regimen including substitution of an antiretroviral agent within a class (defined point 1 above) or the addition/initiation of a new class of drug. Example: Hypothetical treatment pathway as defined by the definition of regimen line used in this document (changes in regimen are bold). Line cart 1 NRTI_A NRTI_B PI_A 2 NRTI_A NRTI_C PI_A 3 NRTI_A NRTI_C PI_A PI_B 4 NRTI_D II_A

Table 1: What percentage of all II usage falls in the 1 st, 2 nd, 3 rd or 4 th + combination therapy regimens. N N 1 29 (13) 40 (12) 2 12 (5) 28 (9) 3 11 (5) 17 (5) 4+ 178 (77) 243 (74) Total 230 328 Table 2: What percentage of all treatment at each line of therapy (1 st, 2 nd, 3 rd. 4 th +) does II account for? (a) Patient numbers and percentages. Non- II II Non- II II N N N N 1 348 (92) 29 (8) 343 (90) 40 (10) 2 254 (95) 12 (5) 249 (90) 28 (10) 3 197 (95) 11 (5) 200 (92) 17 (8) 4+ 875 (83) 178 (17) 779 (76) 243 (24) (b) Percentage comparison between and. Non- II II 1 92 90 8 10 2 95 90 5 10 3 95 92 5 8 4+ 83 76 17 24 Table 3: What are the percentages of other anchor agents (i.e. NNRTI+PI, NRTI+PI, etc) in each of the different lines of therapy? (a) : number of patients and percentages. II NNRTI+PI NRTI NRTI+NNRTI NRTI+PI MONO/DUO Total N N N N N N N 1 29 (8) 5 (1) 7 (2) 248 (66) 88 (23) 0 (0) 377 2 12 (5) 11 (4) 7 (3) 169 (64) 62 (23) 5 (2) 266 3 11 (5) 14 (7) 9 (4) 113 (54) 52 (25) 9 (4) 208 4+ 178 (17) 90 (9) 9 (1) 305 (29) 407 (39) 64 (6) 1053

(b) : number of patients and percentages. II NNRTI+PI NRTI NRTI+NNRTI NRTI+PI MONO/DUO Total N N N N N N N 1 40 (10) 4 (1) 6 (2) 234 (61) 99 (26) 0 (0) 383 2 28 (10) 9 (3) 5 (2) 166 (60) 63 (23) 6 (2) 277 3 17 (8) 13 (6) 6 (3) 122 (56) 52 (24) 7 (3) 217 4+ 243 (24) 78 (8) 9 (1) 289 (28) 352 (34) 51 (5) 1022 (c) Comparison between and. II NNRTI+PI NRTI NRTI+NNRTI NRTI+PI MONO/DUO 1 8 10 1 1 2 2 66 61 23 26 0 0 2 5 10 4 3 3 2 64 60 23 23 2 2 3 5 8 7 6 4 3 54 56 25 24 4 3 4+ 17 24 9 8 1 1 29 28 39 34 6 5 Table 4: What treatment grouping is switched away from when an II is introduced in the 2 nd, 3 rd or 4 th + combination regimens. NOTE: To reduce the total number of possible cart combinations and to avoid direct head- to- head comparison of individual agents, the following groupings are used. Group Label Antiretroviral Therapy Agents abacavir, combivir, didanosine, lamivudine, stavudine, trizivir, NRTI zalcitabine, zidovudine, hydroxyurea, emtricitabine, truvada, kivexa, apricitabine, adefovir, tenofovir, enfuvirtide, IL- 2 NNRTI_1 efavirenz, etravirine NNRTI_2 nevirapine, delavirdine PI_1 atazanavir, darunavir PI_2 kaletra, saquinavir PI_3 amprenavir, indinavir, nelfinavir, ritonavir, tipranavir, fosamprenavir, lopinavir OTHER maraviroc, trial drug (a), regimen switched away from to an II based combination. s where only 1 person switched are not shown. Number^ II regimen switched to from a non- II regimen* 2 NNRTI_1/NRTI 2 NNRTI_2/NRTI 2 NNRTI_2/NRTI/NRTI 2 NNRTI_2/NRTI/PI_2 2 Not Shown 4 3 NNRTI_1/NRTI 4 NRTI/NRTI/PI_1/PI_3 3 NNRTI_1/NRTI/NRTI/PI_3/PI_3 2 Not Shown 8

4+ NRTI/NRTI/PI_1/PI_3 21 NRTI/NRTI/PI_2 15 NRTI/PI_1/PI_3 14 NRTI/PI_2 13 NNRTI_2/NRTI 9 NRTI/NRTI/NRTI/PI_1/PI_3 8 NRTI/PI_1 8 NNRTI_2/NRTI/NRTI 7 NRTI/NRTI 7 NRTI/PI_3/PI_3 7 NNRTI_1/NRTI/NRTI 6 NRTI/NRTI/NRTI 5 NRTI/NRTI/PI_3/PI_3 5 NRTI/NRTI/PI_1 4 NRTI/NRTI/PI_3 4 NRTI/PI_3 4 NNRTI_1/NRTI 3 NNRTI_1/NRTI/NRTI/NRTI 3 NNRTI_2/NRTI/PI_1/PI_3 3 NRTI 3 NRTI/PI_2/PI_3 3 NNRTI_1/NRTI/NRTI/PI_1/PI_3 2 NNRTI_1/NRTI/PI_1/PI_3 2 NRTI/NRTI/NRTI/OTHER/PI_1/PI_3 2 NRTI/NRTI/NRTI/PI_2 2 NRTI/NRTI/OTHER/PI_2 2 NRTI/NRTI/PI_1/PI_2 2 NRTI/OTHER/PI_1/PI_3 2 NRTI/PI_1/PI_2 2 NRTI/PI_2/PI_2 2 PI_1/PI_2 2 PI_1/PI_2/PI_3 2 Not Shown 31 ^as defined when initiating II regimen. *regimen components have been reclassified as per the definitions outlined in Table 4 description.

(b), regimen switched away from to an II based combination. s where only 1 person switched are not shown. Number Non- II regimen switched of Number^ away from to a II regimen* 2 NRTI/PI_1/PI_3 6 NRTI/PI_2 4 NNRTI_2/NRTI 2 Not Shown 10 3 NNRTI_2/NRTI 3 NRTI/NRTI/PI_1/PI_3 2 NRTI/PI_1/PI_3 2 Not Shown 5 4+ NRTI/NRTI/PI_1/PI_3 7 NRTI/PI_1/PI_3 7 NRTI/NRTI/PI_2 6 NRTI/PI_2 5 NNRTI_2/NRTI 4 NNRTI_1/NRTI 3 NNRTI_1/NRTI/PI_2 3 NNRTI_1/NRTI/NRTI 2 NNRTI_2/NRTI/NRTI 2 NNRTI_2/NRTI/PI_2 2 NRTI/NRTI 2 NRTI/NRTI/PI_1 2 NRTI/NRTI/PI_3/PI_3 2 Not Shown 15 ^as defined when initiating II regimen. * components have been reclassified as per the definitions outlined in Table 4 description.

Table 5: What are the top 5 combination regimens utilizing II? (a) top 5 II regimens Integrase Inhibitor Truvada/Raltegravir 26 Atazanavir/Raltegravir 10 Truvada/Ritonavir/Darunavir/Raltegravir 9 Emtricitabine/Tenofovir/Raltegravir 7 Etravirine/Ritonavir/Darunavir/Raltegravir 7 (b) top 5 II regimens Integrase Inhibitor Truvada/Raltegravir 37 Atazanavir/Raltegravir 15 Etravirine/Ritonavir/Darunavir/Raltegravir 13 Kaletra/Raltegravir 10 Emtricitabine/Tenofovir/Raltegravir 9 Truvada/Ritonavir/Darunavir/Raltegravir 9 Ritonavir/Darunavir/Raltegravir 9 Table 6: What treatment grouping is switched to, if II are discontinued? (a), switches from an II based regimen. s where only 1 person switched are not shown. Number switched to from an II regimen* 1 0 2 0 3 0 4+ NRTI/NRTI/PI_1/PI_3 2 Not Shown 4 (b), switches from an II based regimen. s where only 1 person switched are not shown. Number switched to from an II regimen* 1 Not shown 1 2 Not shown 1 3 NNRTI_1/NRTI 2 4+ NNRTI_1/NRTI 2 NRTI/NRTI/PI_2 2 Not shown 6 * components have been reclassified as per the definitions outlined in Table 4 description.

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