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Single-tablet regimen boosts virologic response in acute/early HIV-1 infection

Elaine Soliven
14 Aug 2020

Rapid treatment initiation with a single-tablet regimen comprising darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) demonstrated a high virological response rate in patients with acute or early HIV-1* infection, according to a subgroup analysis of the DIAMOND** study presented at AIDS 2020.

“The limited data [in patients] with acute or early HIV-1 infection suggest that initiation of antiretroviral therapy (ART) may have immunologic and virologic benefits ... [The] US DHHS*** guidelines recommend selection of an ART regimen with a high genetic barrier to resistance, such as D/C/F/TAF, when resistance testing is pending or unavailable (such as rapid initiation scenarios), or poor adherence is suspected,” said Dr Rachel Rogers, medical affairs manager at Janssen Scientific Affairs, LLC in Titusville, New Jersey, US.

This subgroup analysis involved participants diagnosed with acute (n=13, aged 22–56 years) or early HIV-1 infection (n=43, aged 19–44 years) who were given a single-tablet regimen of D/C/F/TAF 800/150/200/10 mg in a rapid initiation setting. At baseline, 46 percent and 21 percent of patients with acute and early HIV-1 infection, respectively, had viral loads of ≥100,000 copies/mL. [AIDS 2020, abstract PEB0089]

At 48 weeks since rapid initiation of D/C/F/TAF, patients with acute or early HIV-1 infection achieved high rates of virologic response (HIV-1 RNA <50 copies/mL) based on the ITT-FDA+ snapshot analysis (77 and 86 percent, respectively) and observed analysis (91 and 97 percent).

HIV-1 RNA <200 copies/mL was achieved by a majority of the patients in the ITT-FDA snapshot analysis (85 percent [acute] and 88 percent [early]), and all patients in the observed analysis (100 percent for both subgroups) at week 48.

The most common adverse events (AEs) across both subgroups were diarrhoea, nausea, and vomiting. One patient with early infection discontinued treatment due to allergic dermatitis (grade 3) and pyrexia and lip swelling (grade 2), all of which resolved after study drug discontinuation.

The researchers found no cases of immune reconstitution inflammatory syndrome and there were no discontinuations due to weight gain, or central nervous system, renal, bone, or gastrointestinal AEs.

“To conclude, high rates of virologic suppression were achieved among patients who rapidly initiated D/C/F/TAF during acute or early infection, including some [patients] with high baseline viral loads,” said Rogers.

“[The] D/C/F/TAF [regimen] was well tolerated, with [only] few serious AEs and none that were considered related to study drug … A high proportion of patients in both subgroups were retained in care through 48 weeks, and no patients discontinued due to noncompliance … [as] adherence rates were high [>95 percent at each study visit in both groups],” she highlighted.

“These findings reinforce the recommendations of using a darunavir-based regimen for rapid initiation, including in those patients with acute or early HIV-1 infection,” she added.

 

*HIV-1: Human immunodeficiency virus type 1

**DIAMOND: A study to evaluate the efficacy and safety of (D/C/F/TAF) once daily fixed dose combination (FDC) regimen in newly diagnosed, antiretroviral treatment-naive human immunodeficiency virus type 1 (HIV-1) infected participants receiving care in a test and treat model of care

***DHHS: Department of Health and Human Services

+FDA: Food and Drug Administration
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