HIV / AIDS

Gilead Sciences will receive FDA review for its investigational bictegravir/lenacapavir (BIC/LEN) single-tablet HIV regimen, with a decision expected by late summer.

Doravirine/islatravir (Idvynso), is a non-INSTI, tenofovir-free alternative for virologically suppressed adults, with efficacy, safety, and potential benefits for aging populations managing complex treatment needs. Amy Colson, MD, MPH, offers some insights about the phase 3 trial and how clinicians may want to consider its use for patients.

The federal agency has given the nod to doravirine/islatravir (Idvynso), a once-daily, 2-drug HIV treatment that demonstrated noninferior efficacy to standard 3-drug regimens in phase 3 trials, expanding options for adults with virological suppression.

New research shows that antiretroviral therapy can reduce HIV-related accelerated biological aging by nearly 4 years, highlighting the critical importance of early and sustained treatment.

A new bipartisan bill aims to eliminate cost barriers and expand access to PrEP by mandating comprehensive coverage and launching a national program for uninsured populations.

By launching during the Super Bowl pregame and the Grammy Awards, Gilead’s One2PrEP campaign used music, mainstream media, and bold visibility to normalize conversations about HIV prevention and expand awareness of evolving PrEP options.

Phase 1 data show that the long-acting HIV-1 capsid inhibitor VH-499 is well tolerated as a single intramuscular or subcutaneous injection and demonstrates pharmacokinetics supportive of long-acting dosing intervals.

Amy Colson, MD, MPH, discusses data from the MK-8591A-052 trial that showed that switching to doravirine/islatravir maintained durable virologic suppression with efficacy and safety comparable to continuing bictegravir/emtricitabine/tenofovir alafenamide.

New 96-week subgroup data from the PASO-DOBLE study show that adults with virologically suppressed HIV who switched to dolutegravir/lamivudine experienced significantly lower rates of steatotic liver disease than those who switched to bictegravir/emtricitabine/tenofovir alafenamide, particularly among individuals with clinically meaningful weight gain.

In the phase 3 ARTISTRY-2 trial, switching people with virologically suppressed HIV from B/F/TAF to a once-daily bictegravir/lenacapavir single-tablet regimen maintained viral suppression through week 48 with comparable safety and tolerability.

In a phase 3 study of virologically suppressed adults with HIV, switching to once-daily doravirine/islatravir (DOR/ISL 100/0.25 mg) maintained high rates of viral suppression through 96 weeks, with no emergent resistance and a favorable safety profile.

In the final FY2026 spending bill, Congress rejected proposed House Republican cuts of more than $1.7 billion and instead maintained bipartisan funding for HIV prevention and treatment programs, while urging the Trump administration to focus on effective implementation.

The twice-yearly injectable, which significantly reduces HIV incidence compared with oral regimens, has high adherence and manageable adverse effects.

Amy Colson, MD, MPH, discusses phase 2 data showing durable virologic suppression, low resistance risk, and favorable safety with weekly oral islatravir plus lenacapavir in suppressed adults with HIV.

Zandraetta Tims-Cook, MD, MPH, AAHIVS, discusses access challenges, missed-dose management, and scalable care models for cabotegravir PrEP in women.

Gilead Sciences reported positive phase 3 ARTISTRY-2 results demonstrating that a once-daily single-tablet combination of bictegravir and lenacapavir is statistically noninferior to bictegravir/emtricitabine/tenofovir alafenamide tablets in virologically suppressed adults with HIV. The company plans to file for regulatory submissions for approval.

WHO and UNAIDS warn of service disruptions, widening inequities, and mounting drug-resistance threats, while highlighting innovations and commitments needed to end AIDS as a public health threat.

Merck’s investigational once-daily, 2-drug HIV regimen, doravirine/islatravir, achieved its primary efficacy and safety end points in a phase 3 trial.

Gilead reports its investigational single tablet of bictegravir and lenacapavir was efficacious in people with HIV who are virologically suppressed and who switched from taking multitablet regimens. The company says its phase 3 study results will form the basis for its future regulatory submissions.

New 96-week results from the study show that Dovato is as effective as Biktarvy in maintaining viral suppression in adults with HIV, while leading to less weight gain and fewer drug-related adverse events.

Initial findings from the phase 1 CLARITY study offer the first direct comparison of the acceptability and tolerability of single-dose cabotegravir and lenacapavir long-acting injections in HIV-negative adults, revealing differences in patient and health care provider preferences.

This newly approved long-acting injectable PrEP offers 6 months of HIV protection, and represents a major scientific and policy breakthrough. However, its success will depend on ensuring equitable access, enforcing coverage requirements, and maintaining a robust, multi-faceted HIV prevention infrastructure amid political and systemic challenges.

Today’s MMWR recommends twice-yearly subcutaneous lenacapavir for people ≥35 kg, citing PURPOSE-1/2 efficacy, a favorable safety profile with mostly mild to moderate injection-site reactions, and potential adherence benefits.

William Hanage, PhD, discusses viral evolution, transmission risk, and clinical implications for immunocompromised patients.

Up to 2 million people in low- and lower-middle-income countries may gain access to the long-acting PrEP option under a three-year, no-profit agreement.