Drug Overview
Stribild is a single-tablet regimen for the treatment of HIV-1 infection. It is a co-formulation of the marketed fixed-dose combination (FDC) Truvada ([emtricitabine + TDF]; Gilead/Japan Tobacco), along with Vitekta (elvitegravir; Gilead/Japan Tobacco) and Tybost (cobicistat; Gilead). Truvada is an FDC of the nucleos(t)ide reverse transcriptase inhibitors (NRTIs) Emtriva (emtricitabine; Gilead) and Viread (TDF; Gilead). NRTIs and non-NRTIs block the action of the viral reverse transcriptase enzyme, preventing synthesis of viral DNA and subsequently inhibiting viral replication. Vitekta is a pharmacokinetically boosted integrase strand transfer inhibitor (INSTI) that is also being marketed by Gilead as a standalone agent. INSTIs block the activity of the HIV integrase enzyme, preventing reverse-transcribed viral DNA from integrating into the human genome, and subsequent viral replication. Tybost is a boosting agent which inhibits cytochrome P450 3A4, an enzyme that metabolizes drugs, including INSTIs and protease inhibitors (PIs). This enables enhanced pharmacokinetics of INSTIs and PIs, allowing decreased dosing and a reduction in adverse events.
In a bid to mitigate the impact of generic versions of TDF on its HIV revenues, Gilead has heavily promoted the cannibalization of Stribild’s patient share by its successor tenofovir alafenamide (TAF)-based product Biktarvy ([bictegravir + emtricitabine + TAF]; Gilead). Indeed, in its Q1 2019 earnings call, the company noted that TAF-based products now comprise over 80% of its HIV prescription volume in the US and EU, suggesting that the majority of physicians are convinced by TAF’s superior renal and bone safety data compared to TDF. As a result, Stribild’s revenues are expected to continue to decline rapidly as more patients are swapped to Biktarvy, which also has the benefit of not including a boosting agent, meaning that patient management is simplified by reducing the potential for drug-drug interactions.
Analyst Outlook
In a bid to mitigate the impact of generic versions of tenofovir disoproxil fumarate (TDF) on its HIV revenues, Gilead has heavily promoted the cannibalization of Stribild’s ([elvitegravir + cobicistat + emtricitabine + TDF; Gilead/Japan Tobacco]) patient share by its successor tenofovir alafenamide (TAF)-based product Biktarvy ([bictegravir + emtricitabine + TAF]; Gilead). Indeed, in its Q1 2019 earnings call, the company noted that TAF-based products now comprise over 80% of its HIV prescription volume in the US and EU, suggesting that the majority of physicians are convinced by TAF’s superior renal and bone safety data compared to TDF. As a result, Stribild’s revenues are expected to continue to decline rapidly as more patients are swapped to Biktarvy, which also has the benefit of not including a boosting agent, meaning that patient management is simplified by reducing the potential for drug-drug interactions.
Stribild is a single-tablet regimen for the treatment of HIV-1 infection. It is a co-formulation of the marketed fixed-dose combination (FDC) Truvada ([emtricitabine + TDF]; Gilead/Japan Tobacco), along with Vitekta (elvitegravir; Gilead/Japan Tobacco) and Tybost (cobicistat; Gilead). Truvada is an FDC of the nucleos(t)ide reverse transcriptase inhibitors (NRTIs) Emtriva (emtricitabine; Gilead) and Viread (TDF; Gilead). NRTIs and non-NRTIs block the action of the viral reverse transcriptase enzyme, preventing synthesis of viral DNA and subsequently inhibiting viral replication. Vitekta is a pharmacokinetically boosted integrase strand transfer inhibitor (INSTI) that is also being marketed by Gilead as a standalone agent. INSTIs block the activity of the HIV integrase enzyme, preventing reverse-transcribed viral DNA from integrating into the human genome, and subsequent viral replication. Tybost is a boosting agent which inhibits cytochrome P450 3A4, an enzyme that metabolizes drugs, including INSTIs and protease inhibitors (PIs). This enables enhanced pharmacokinetics of INSTIs and PIs, allowing decreased dosing and a reduction in adverse events.
In a bid to mitigate the impact of generic versions of TDF on its HIV revenues, Gilead has heavily promoted the cannibalization of Stribild’s patient share by its successor tenofovir alafenamide (TAF)-based product Biktarvy ([bictegravir + emtricitabine + TAF]; Gilead). Indeed, in its Q1 2019 earnings call, the company noted that TAF-based products now comprise over 80% of its HIV prescription volume in the US and EU, suggesting that the majority of physicians are convinced by TAF’s superior renal and bone safety data compared to TDF. As a result, Stribild’s revenues are expected to continue to decline rapidly as more patients are swapped to Biktarvy, which also has the benefit of not including a boosting agent, meaning that patient management is simplified by reducing the potential for drug-drug interactions.
Analyst Outlook
In a bid to mitigate the impact of generic versions of tenofovir disoproxil fumarate (TDF) on its HIV revenues, Gilead has heavily promoted the cannibalization of Stribild’s ([elvitegravir + cobicistat + emtricitabine + TDF; Gilead/Japan Tobacco]) patient share by its successor tenofovir alafenamide (TAF)-based product Biktarvy ([bictegravir + emtricitabine + TAF]; Gilead). Indeed, in its Q1 2019 earnings call, the company noted that TAF-based products now comprise over 80% of its HIV prescription volume in the US and EU, suggesting that the majority of physicians are convinced by TAF’s superior renal and bone safety data compared to TDF. As a result, Stribild’s revenues are expected to continue to decline rapidly as more patients are swapped to Biktarvy, which also has the benefit of not including a boosting agent, meaning that patient management is simplified by reducing the potential for drug-drug interactions.
Table of Contents
OVERVIEW
LIST OF FIGURES
LIST OF TABLES
