A high proportion of patients with newly diagnosed HIV-1 infection achieved an undetectable viral load through 48 weeks after starting Symtuza (Janssen) within two weeks of diagnosis, according to new data from the DIAMOND study.
Symtuza combines darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg and was approved in the United States in July 2018 for treatment-naive and certain virologically suppressed adults with HIV-1 infection.
White pills in bottles. Source: Getty
"Rapid initiation of antiretroviral therapy is emerging as the standard of HIV care, with global guidelines starting to recommend that all people living with HIV be treated as soon as possible once a diagnosis is confirmed," study investigator Dr. Moti Ramgopal of Midway Immunology and Research Center, in Fort Pierce, Florida, told Reuters Health by email.
"It could be an additional strategy in our quest to achieve the 90/90/90 prevention and treatment goals (http://bit.ly/2UmX0hz) as outlined by UNAIDS. The DIAMOND study not only adds to the literature on Symtuza but also further reinforces this concept as it is the first Phase 3 trial studying the rapid initiation of a single-tablet regimen (STR)," Dr. Ramgopal added.
The 48-week results, presented April 11 at the American Conference for the Treatment of HIV in Miami, follow presentation of 24-week results at the 2018 International AIDS Conference, and support the safety, efficacy and tolerability profile of rapid initiation of Symtuza in antiretroviral treatment-naive adults with HIV-1, Janssen said in a news release announcing the results.
The DIAMOND study enrolled 109 treatment-naive adults within 14 days after receiving an HIV diagnosis, with 30% of patients enrolled within 48 hours of diagnosis. All were started on once-daily Symtuza before laboratory or baseline resistance test results were available.
At 48 weeks, in the primary intent-to-treat analysis, 92 patients (84%) achieved undetectable viral loads (<50 copies/mL) and nine patients had virologic failure (viral load 50 copies/mL or higher).
In an analysis excluding patients with missing data, 96% of patients achieved undetectable viral loads, and all patients achieved viral loads of less than 200 copies/mL at 48 weeks. No patient discontinued treatment due to lack of efficacy.
Symtuza was well-tolerated with no serious related adverse events. The most common adverse drug reactions were diarrhea, nausea, rash, vomiting and fatigue. Grade 3 and 4 laboratory abnormalities included increases in aspartate aminotransferase (5%), alanine aminotransferase (3%) or bilirubin (3%). The vast majority of patients (97%) said they were satisfied with treatment.
In an email to Reuters Health, Dr. Keith Dunn, U.S. Medical Director, Infectious Diseases, at Janssen, noted, "Most studies examining rapid initiation to date have been conducted in more resource-limited settings or have utilized regimens that do not offer STRs. They may not be reflective of the clinical scenarios that providers and patients newly diagnosed with HIV in the U.S are dealing with today. The DIAMOND trial aimed to explore the efficacy and safety of Symtuza patients rapidly starting treatment in the U.S."
"Furthermore," said Dr. Dunn, "we recently demonstrated when HIV treatment is delayed, even by one week after diagnosis, patients may incur higher total accumulated healthcare costs, inclusive of both medical and pharmacy costs compared to those who rapidly initiate treatment out to three years of follow-up. With the clinical and economic benefits clearly favoring rapid initiation, and the findings from DIAMOND, it is important to recognize that Symtuza is the only evidence-based STR recommended by the U.S. Department of Health and Human Services for rapid initiation."
Janssen funded the study and provided support for medical writing. Dr. Ramgopal has received research support from Janssen and has served as a paid consultant to the company.
American Conference for the Treatment of HIV 2019.