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Rachel V Thomas

Once-Weekly Oral Combination HIV Pill Shows Promise As Alternative to Daily Treatment

A once-weekly oral HIV combination therapy may offer an effective alternative to standard daily treatment, according to results from a global phase 3 clinical trial.

The weekly tablet combines two long-acting antiretroviral medicines — Merck’s islatravir and Gilead Sciences’ lenacapavir — with complementary mechanisms of action that enable once-weekly dosing. The combination could reduce the burden of lifelong daily pill-taking for people living with HIV, revealed the trial published in the New England Journal of Medicine last week.

The randomized, double-blind trial evaluated a once-weekly combination tablet containing islatravir and lenacapavir in adults whose HIV had remained suppressed for at least six months while taking the daily regimen bictegravir–emtricitabine–tenofovir alafenamide by Gilead.

The international study involved 607 adults across 106 clinical sites in 12 countries. Participants who had maintained viral suppression on standard daily treatment were randomly assigned either to switch to the once-weekly tablet or remain on their existing daily medication.

After 48 weeks, the once-weekly regimen proved non-inferior to the standard once-daily treatment. Overall, 93.4% of participants taking the weekly regimen and 92.4% of those continuing daily therapy maintained viral suppression.

No participants receiving the weekly treatment experienced virological failure. At week 48, no participants taking the once-weekly regimen had a viral load of 50 copies per milliliter or higher, compared with one participant (0.3%) in the daily-treatment group.

None of the participants developed resistance to either islatravir or lenacapavir.

Levels of CD4+ T-cells and total lymphocytes, which are immune cells that help fight infections, remained stable in both groups.

Earlier studies of higher daily doses of islatravir raised concerns about declines in immune cell counts.

About 80% of participants in each group experienced at least one mild or moderate adverse event, such as headache or diarrhea.

Serious adverse events were less common, occurring in 16 participants (5.3%) receiving the weekly regimen and 14 participants (4.6%) receiving daily therapy.

Six participants in the weekly regimen group and five in the daily-treatment group discontinued treatment due to adverse events. No deaths were reported.

“As such, these findings support the safety of the current weekly 2-mg [milligram] dose of islatravir,” the researchers wrote in the paper.

Both islatravir and lenacapavir are US FDA-approved, but their combination is not.

Islatravir is approved by the FDA in combination with doravirine and is marketed as Idvynso. It is prescribed as a daily oral treatment for virologically suppressed adults.

Lenacapavir is also approved by the FDA as a multi-drug component for treatment-resistant HIV, marketed as Sunlenca. It is also approved as a twice-yearly injection for HIV prevention or PrEP, marketed as Yeztugo.

The study remains ongoing and participants will continue to be followed for a total of 96 weeks to assess longer-term safety and effectiveness.

The researchers said that the once-weekly oral regimen could also help address “pill fatigue,” or the mental and emotional burden of taking medication every day.

For some patients, a weekly oral regimen may be more convenient than long-acting injectable HIV therapies, which require regular clinic visits.

“The first ever weekly oral therapy for the treatment of HIV could offer welcome relief from the burden of life-long daily pill-taking for people living with HIV. This is especially important for people that are experiencing stigma and people with other HIV-associated health conditions who are taking multiple other tablets,” said Professor Chloe Orkin MBE, Professor of Infection and Inequities and Dean for Healthcare Transformation at Queen Mary University of London.

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A once-weekly oral HIV combination therapy may offer an effective alternative to standard daily treatment, according to results from a global phase 3 clinical trial.The weekly tablet combines two long-acting antiretroviral medicines — Merck’s islatravir and Gilead Sciences’ lenacapavir — with complementary mechanisms of action that enable once-weekly dosing. The combination could reduce the burden of lifelong daily pill-taking for people living with HIV, revealed the trial published in the New England Journal of Medicine last week.What Did The New Trial Show?The randomized, double-blind trial evaluated a once-weekly combination tablet containing islatravir and lenacapavir in adults whose HIV had remained suppressed for at least six months while taking the daily regimen bictegravir–emtricitabine–tenofovir alafenamide by Gilead.The international study involved 607 adults across 106 clinical sites in 12 countries. Participants who had maintained viral suppression on standard daily treatment were randomly assigned either to switch to the once-weekly tablet or remain on their existing daily medication.After 48 weeks, the once-weekly regimen proved non-inferior to the standard once-daily treatment. Overall, 93.4% of participants taking the weekly regimen and 92.4% of those continuing daily therapy maintained viral suppression.No participants receiving the weekly treatment experienced virological failure. At week 48, no participants taking the once-weekly regimen had a viral load of 50 copies per milliliter or higher, compared with one participant (0.3%) in the daily-treatment group.None of the participants developed resistance to either islatravir or lenacapavir.CD4+ T-Cell Levels Remained StableLevels of CD4+ T-cells and total lymphocytes, which are immune cells that help fight infections, remained stable in both groups.Earlier studies of higher daily doses of islatravir raised concerns about declines in immune cell counts.Comparable Safety ProfileAbout 80% of participants in each group experienced at least one mild or moderate adverse event, such as headache or diarrhea.Serious adverse events were less common, occurring in 16 participants (5.3%) receiving the weekly regimen and 14 participants (4.6%) receiving daily therapy.Six participants in the weekly regimen group and five in the daily-treatment group discontinued treatment due to adverse events. No deaths were reported.“As such, these findings support the safety of the current weekly 2-mg [milligram] dose of islatravir,” the researchers wrote in the paper.Both Drugs Are FDA-approved Both islatravir and lenacapavir are US FDA-approved, but their combination is not.Islatravir is approved by the FDA in combination with doravirine and is marketed as Idvynso. It is prescribed as a daily oral treatment for virologically suppressed adults.Lenacapavir is also approved by the FDA as a multi-drug component for treatment-resistant HIV, marketed as Sunlenca. It is also approved as a twice-yearly injection for HIV prevention or PrEP, marketed as Yeztugo.The study remains ongoing and participants will continue to be followed for a total of 96 weeks to assess longer-term safety and effectiveness.Could Reduce ‘Pill Fatigue’The researchers said that the once-weekly oral regimen could also help address “pill fatigue,” or the mental and emotional burden of taking medication every day.For some patients, a weekly oral regimen may be more convenient than long-acting injectable HIV therapies, which require regular clinic visits.“The first ever weekly oral therapy for the treatment of HIV could offer welcome relief from the burden of life-long daily pill-taking for people living with HIV. This is especially important for people that are experiencing stigma and people with other HIV-associated health conditions who are taking multiple other tablets,” said Professor Chloe Orkin MBE, Professor of Infection and Inequities and Dean for Healthcare Transformation at Queen Mary University of London.

once-weekly oral combination hiv pill shows promise as alternative to daily treatment

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