Complera
Author: Karolina Kujawa
Publisher: Datamonitor Healthcare
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Drug Overview
Complera ([rilpivirine + emtricitabine + tenofovir disoproxil fumarate (TDF)]; Gilead/Johnson & Johnson) is a single-tablet regimen (STR) approved for the treatment of HIV-1 infection. In the five major EU markets (France, Germany, Italy, Spain, and the UK), Complera is marketed under the brand name Eviplera. Complera is a co-formulation of the marketed HIV drugs Edurant (rilpivirine; Johnson & Johnson) and Truvada. Edurant is a non-nucleoside reverse transcriptase inhibitor (NNRTI), while Truvada is a fixed-dose combination of the nucleos(t)ide reverse transcriptase inhibitors (NRTIs) Emtriva (emtricitabine; Gilead) and Viread (TDF; Gilead). NRTIs and NNRTIs block the action of the viral reverse transcriptase enzyme, preventing synthesis of viral DNA and subsequently inhibiting viral replication.
Complera’s sales have fallen significantly from their 2016 peak as its patient share is gradually cannibalized by Odefsey ([rilpivirine + emtricitabine + tenofovir alafenamide (TAF)]; Gilead/Johnson & Johnson), and as the relevance of its positioning as a more tolerable alternative to Atripla ([efavirenz + emtricitabine + TDF]; Gilead) declines. Both US and EU treatment guidelines now heavily favor integrase strand transfer inhibitor-based single-tablet regimens (STRs) as first-line treatment options, meaning that Complera’s treatment-naïve patient share will continue to decline going forward.
Analyst Outlook
Complera’s ([rilpivirine + emtricitabine + tenofovir disoproxil fumarate (TDF)]; Gilead/Johnson & Johnson) sales have fallen significantly from their 2016 peak as its patient share is gradually cannibalized by Odefsey ([rilpivirine + emtricitabine + tenofovir alafenamide (TAF)]; Gilead/Johnson & Johnson), and as the relevance of its positioning as a more tolerable alternative to Atripla ([efavirenz + emtricitabine + TDF]; Gilead) declines. Both US and EU treatment guidelines now heavily favor integrase strand transfer inhibitorbased single-tablet regimens (STRs) as first-line treatment options, meaning that Complera’s treatment-naïve patient share will continue to decline going forward.
Complera’s sales are expected to further decrease due to the competition from novel, cheaper STRs, which do not have a requirement for co-administration with food. It will face competition from Delstrigo ([doravirine + lamivudine + TDF]; Merck & Co), as doravirine has the advantage of sustained efficacy in patients with high baseline viral loads (rilpivirine is associated with higher rates
of virologic failure in patients with baseline HIV RNA >100,000 copies/ml) and can be dosed independently of food.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Complera : HIV
LIST OF FIGURES
10 Figure 1: Datamonitor Healthcare’s drug assessment summary of Complera for HIV
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of Complera for HIV
13 Figure 3: Complera sales for HIV across the US and five major EU markets, by country, 2018–27
LIST OF TABLES
6 Table 1: Complera drug profile
7 Table 2: Approval history of Complera for HIV in the US, Japan, and five major EU markets
8 Table 3: Late-phase trials of Complera for HIV
9 Table 4: Complera for HIV – SWOT analysis
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