Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis
Background: Treatment during acute or early human immunodeficiency virus (HIV)-1 infection is associated with immunologic and virologic benefits. Objective: To evaluate darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) efficacy/safety among patients with acute or early HIV-1 infec...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2021-07-01
|
| Series: | HIV Research & Clinical Practice |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/25787489.2021.1915652 |
| _version_ | 1827794828497256448 |
|---|---|
| author | Keith Dunn Rachel Rogers Richard Bruce Simonson Donghan Luo Shubin Sheng Purnima T. Kassam Sareh Seyedkazemi Hélène Hardy |
| author_facet | Keith Dunn Rachel Rogers Richard Bruce Simonson Donghan Luo Shubin Sheng Purnima T. Kassam Sareh Seyedkazemi Hélène Hardy |
| author_sort | Keith Dunn |
| collection | DOAJ |
| description | Background: Treatment during acute or early human immunodeficiency virus (HIV)-1 infection is associated with immunologic and virologic benefits. Objective: To evaluate darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) efficacy/safety among patients with acute or early HIV-1 infection who rapidly initiate treatment. Methods: DIAMOND (ClinicalTrials.gov Identifier: NCT03227861), a phase 3 study, evaluated the efficacy/safety of D/C/F/TAF 800/150/200/10 mg in rapid initiation. Adults aged ≥18 years began D/C/F/TAF within 14 days of diagnosis, prior to the availability of screening/baseline laboratory results. In this subgroup analysis, virologic response (HIV-1 RNA <50 copies/mL) was assessed at Week 48 by intent-to-treat FDA snapshot (ITT-FDA snapshot) and observed (excluding patients with missing data) analyses in patients with acute (HIV-1 antibody negative and HIV-1 RNA positive/p24 positive) or early (HIV-1 antibody positive and suspected infection ≤6 months before screening/baseline) infection. Results: Among 109 patients, 13 had acute and 43 had early HIV-1 infection. High rates of virologic response were demonstrated at Week 48 by ITT-FDA snapshot (acute: 10/13 [76.9%]; early: 37/43 [86.0%]) and observed (acute: 10/11 [90.9%]; early: 37/38 [97.4%]) analyses. No patients discontinued or required regimen change due to baseline resistance or lack of efficacy, or developed protocol-defined virologic failure. Through Week 48, 7 (53.8%) acute and 22 (51.2%) early infection patients had a D/C/F/TAF-related adverse event (AE); none had a D/C/F/TAF-related grade 4 or serious AE. Conclusions: High rates of viral suppression during acute/early infection were achieved with D/C/F/TAF rapid initiation, no treatment-emergent resistant mutations were observed, and D/C/F/TAF was safe and well tolerated. |
| first_indexed | 2024-03-11T18:39:25Z |
| format | Article |
| id | doaj.art-04000d73446f4fdd8103c85c2ad64480 |
| institution | Directory Open Access Journal |
| issn | 2578-7470 |
| language | English |
| last_indexed | 2024-03-11T18:39:25Z |
| publishDate | 2021-07-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | HIV Research & Clinical Practice |
| spelling | doaj.art-04000d73446f4fdd8103c85c2ad644802023-10-12T13:43:53ZengTaylor & Francis GroupHIV Research & Clinical Practice2578-74702021-07-01222556110.1080/25787489.2021.19156521915652Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysisKeith Dunn0Rachel Rogers1Richard Bruce Simonson2Donghan Luo3Shubin Sheng4Purnima T. Kassam5Sareh Seyedkazemi6Hélène Hardy7Janssen Scientific Affairs, LLCJanssen Scientific Affairs, LLCJanssen Scientific Affairs, LLCJanssen Research & Development, LLCJanssen Research & Development, LLCJanssen Scientific Affairs, LLCJanssen Scientific Affairs, LLCJanssen Research & Development, LLCBackground: Treatment during acute or early human immunodeficiency virus (HIV)-1 infection is associated with immunologic and virologic benefits. Objective: To evaluate darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) efficacy/safety among patients with acute or early HIV-1 infection who rapidly initiate treatment. Methods: DIAMOND (ClinicalTrials.gov Identifier: NCT03227861), a phase 3 study, evaluated the efficacy/safety of D/C/F/TAF 800/150/200/10 mg in rapid initiation. Adults aged ≥18 years began D/C/F/TAF within 14 days of diagnosis, prior to the availability of screening/baseline laboratory results. In this subgroup analysis, virologic response (HIV-1 RNA <50 copies/mL) was assessed at Week 48 by intent-to-treat FDA snapshot (ITT-FDA snapshot) and observed (excluding patients with missing data) analyses in patients with acute (HIV-1 antibody negative and HIV-1 RNA positive/p24 positive) or early (HIV-1 antibody positive and suspected infection ≤6 months before screening/baseline) infection. Results: Among 109 patients, 13 had acute and 43 had early HIV-1 infection. High rates of virologic response were demonstrated at Week 48 by ITT-FDA snapshot (acute: 10/13 [76.9%]; early: 37/43 [86.0%]) and observed (acute: 10/11 [90.9%]; early: 37/38 [97.4%]) analyses. No patients discontinued or required regimen change due to baseline resistance or lack of efficacy, or developed protocol-defined virologic failure. Through Week 48, 7 (53.8%) acute and 22 (51.2%) early infection patients had a D/C/F/TAF-related adverse event (AE); none had a D/C/F/TAF-related grade 4 or serious AE. Conclusions: High rates of viral suppression during acute/early infection were achieved with D/C/F/TAF rapid initiation, no treatment-emergent resistant mutations were observed, and D/C/F/TAF was safe and well tolerated.http://dx.doi.org/10.1080/25787489.2021.1915652hiv-1acute hiv-1 infectionearly hiv-1 infectionrapid initiationdarunavir |
| spellingShingle | Keith Dunn Rachel Rogers Richard Bruce Simonson Donghan Luo Shubin Sheng Purnima T. Kassam Sareh Seyedkazemi Hélène Hardy Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis HIV Research & Clinical Practice hiv-1 acute hiv-1 infection early hiv-1 infection rapid initiation darunavir |
| title | Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis |
| title_full | Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis |
| title_fullStr | Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis |
| title_full_unstemmed | Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis |
| title_short | Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis |
| title_sort | rapid initiation of darunavir cobicistat emtricitabine tenofovir alafenamide in acute and early hiv 1 infection a diamond subgroup analysis |
| topic | hiv-1 acute hiv-1 infection early hiv-1 infection rapid initiation darunavir |
| url | http://dx.doi.org/10.1080/25787489.2021.1915652 |
| work_keys_str_mv | AT keithdunn rapidinitiationofdarunavircobicistatemtricitabinetenofoviralafenamideinacuteandearlyhiv1infectionadiamondsubgroupanalysis AT rachelrogers rapidinitiationofdarunavircobicistatemtricitabinetenofoviralafenamideinacuteandearlyhiv1infectionadiamondsubgroupanalysis AT richardbrucesimonson rapidinitiationofdarunavircobicistatemtricitabinetenofoviralafenamideinacuteandearlyhiv1infectionadiamondsubgroupanalysis AT donghanluo rapidinitiationofdarunavircobicistatemtricitabinetenofoviralafenamideinacuteandearlyhiv1infectionadiamondsubgroupanalysis AT shubinsheng rapidinitiationofdarunavircobicistatemtricitabinetenofoviralafenamideinacuteandearlyhiv1infectionadiamondsubgroupanalysis AT purnimatkassam rapidinitiationofdarunavircobicistatemtricitabinetenofoviralafenamideinacuteandearlyhiv1infectionadiamondsubgroupanalysis AT sarehseyedkazemi rapidinitiationofdarunavircobicistatemtricitabinetenofoviralafenamideinacuteandearlyhiv1infectionadiamondsubgroupanalysis AT helenehardy rapidinitiationofdarunavircobicistatemtricitabinetenofoviralafenamideinacuteandearlyhiv1infectionadiamondsubgroupanalysis |