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Gilead (GILD) & MRK's HIV Oral Combo Shows Efficacy in Phase II
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Gilead Sciences (GILD - Free Report) and Merck (MRK - Free Report) announced promising first data from a phase II study evaluating the combination of a once-weekly treatment regimen of Merck’s islatravir and Gilead’s lenacapavir.
The data demonstrated the efficacy of this potential long-acting oral combination treatment option in maintaining viral suppression in individuals with HIV.
At the 24-week mark, the combination of islatravir and lenacapavir showcased an impressive 94.2% rate of viral suppression (HIV-1 RNA <50 copies/mL), with only one participant experiencing a viral load of >50 copies/mL at Week 24, which was suppressed by Week 30. This novel investigational combination not only demonstrated potent antiviral activity but also boasted favorable pharmacokinetic profiles, supporting its development as a once-weekly oral regimen.
The phase II study (NCT05052996) involved virologically suppressed adults who were randomly assigned to receive either oral islatravir and lenacapavir once weekly or continue daily oral Biktarvy. Notably, both treatment groups maintained comparable high rates of HIV suppression at Week 24, underscoring the efficacy of the investigational combination regimen.
These findings were presented at the 31st Conference on Retroviruses and Opportunistic Infections.
The significance of this development lies in its potential to address several key challenges faced by individuals living with HIV. While daily oral therapies have been transformative, the prospect of a less frequent dosing regimen holds promise in enhancing treatment adherence, reducing stigma and improving overall patient outcomes. If approved, the combination of islatravir and lenacapavir will be the first oral weekly HIV treatment.
In the past year, Gilead’s stock has declined 9.5% compared with the industry‘s 4.5% decline.
Image Source: Zacks Investment Research
In the past year, Merck’s stock has gained 11.2% compared with the industry’s 31.4% rise.
Image Source: Zacks Investment Research
While islatravir, alone or in combination with lenacapavir, remains investigational, lenacapavir is marketed as Sunlenca in several countries, including the United States and EU, for the treatment of people with multi-drug resistant HIV in combination with other antiretroviral (s).
Gilead Sciences has been a longstanding leader in HIV research and development. With a track record of groundbreaking innovations, including the first single-tablet regimen and the first antiretroviral for pre-exposure prophylaxis, Gilead continues to drive advancements in HIV treatment, prevention, and cure research.
Other than Gilead and Merck, some other key players in the HIV market are ViiV Healthcare, a joint venture between GSK, Pfizer, and Shionogi, Bristol Myers Squibb (BMY - Free Report) and J&J (JNJ - Free Report) .
ViiV Healthcare’s portfolio includes several leading medications for the treatment of HIV, such as dolutegravir-based regimens. Bristol-Myers’s HIV portfolio includes medications like Reyataz (atazanavir) and Evotaz, while J&J’s portfolio has drugs like Prezista (darunavir) and Edurant (rilpivirine).
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.
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Gilead (GILD) & MRK's HIV Oral Combo Shows Efficacy in Phase II
Gilead Sciences (GILD - Free Report) and Merck (MRK - Free Report) announced promising first data from a phase II study evaluating the combination of a once-weekly treatment regimen of Merck’s islatravir and Gilead’s lenacapavir.
The data demonstrated the efficacy of this potential long-acting oral combination treatment option in maintaining viral suppression in individuals with HIV.
At the 24-week mark, the combination of islatravir and lenacapavir showcased an impressive 94.2% rate of viral suppression (HIV-1 RNA <50 copies/mL), with only one participant experiencing a viral load of >50 copies/mL at Week 24, which was suppressed by Week 30. This novel investigational combination not only demonstrated potent antiviral activity but also boasted favorable pharmacokinetic profiles, supporting its development as a once-weekly oral regimen.
The phase II study (NCT05052996) involved virologically suppressed adults who were randomly assigned to receive either oral islatravir and lenacapavir once weekly or continue daily oral Biktarvy. Notably, both treatment groups maintained comparable high rates of HIV suppression at Week 24, underscoring the efficacy of the investigational combination regimen.
These findings were presented at the 31st Conference on Retroviruses and Opportunistic Infections.
The significance of this development lies in its potential to address several key challenges faced by individuals living with HIV. While daily oral therapies have been transformative, the prospect of a less frequent dosing regimen holds promise in enhancing treatment adherence, reducing stigma and improving overall patient outcomes. If approved, the combination of islatravir and lenacapavir will be the first oral weekly HIV treatment.
In the past year, Gilead’s stock has declined 9.5% compared with the industry‘s 4.5% decline.
Image Source: Zacks Investment Research
In the past year, Merck’s stock has gained 11.2% compared with the industry’s 31.4% rise.
Image Source: Zacks Investment Research
While islatravir, alone or in combination with lenacapavir, remains investigational, lenacapavir is marketed as Sunlenca in several countries, including the United States and EU, for the treatment of people with multi-drug resistant HIV in combination with other antiretroviral (s).
Gilead Sciences has been a longstanding leader in HIV research and development. With a track record of groundbreaking innovations, including the first single-tablet regimen and the first antiretroviral for pre-exposure prophylaxis, Gilead continues to drive advancements in HIV treatment, prevention, and cure research.
Other than Gilead and Merck, some other key players in the HIV market are ViiV Healthcare, a joint venture between GSK, Pfizer, and Shionogi, Bristol Myers Squibb (BMY - Free Report) and J&J (JNJ - Free Report) .
ViiV Healthcare’s portfolio includes several leading medications for the treatment of HIV, such as dolutegravir-based regimens. Bristol-Myers’s HIV portfolio includes medications like Reyataz (atazanavir) and Evotaz, while J&J’s portfolio has drugs like Prezista (darunavir) and Edurant (rilpivirine).
Zacks Rank
Currently, Merck and Gilead have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.