The NDA submission was based on data from 2 multicenter, open-label, parallel-group studies (ATLAS and FLAIR) which demonstrated that the 2-drug regimen administered by intramuscular injection every 4 weeks was non-inferior to a standard of care 3-drug oral regimen in maintaining viral suppression in adults with HIV-1 infection (primary endpoint), as measured by the proportion of patients with HIV-1 RNA ≥50 copies/mL at Week 48. In both studies, virologic suppression rates (HIV-1 RNA <50 copies/mL) were found to be similar between the 2 treatment arms at Week 48.
Commenting on the NDA submission, Brian Woodfall, MD, Global Head, Development, Infectious Diseases; Janssen Biopharma, Inc. said, “We believe this once-monthly injectable regimen has the potential to offer many people living; with HIV a treatment option that does not require taking pills every day.”
Non-nucleoside reverse transcriptase inhibitor (NNRTI)
Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI); but is currently approving in an oral formulation to treat HIV-1 in combination with other antiretrovirals; while cabotegravir is an investigational integrase inhibitor. In addition to the NDA for the injectable formulation; a second NDA for an oral form of cabotegravir has also been submitting for review for treatment in combination with oral rilpivirine.
Substantially less mental health research has been conducting; in young adults and adolescents compared with adults; and such evidence is especially sparse in resource-limited settings. Noting that the burden of illness may be particularly pronouncing in children and adolescents living with HIV; the authors of a recent review examined the available literature regarding mental health care access, treatment outcomes; and the role of mental health problems in the transition from pediatric to adult care in this patient population.
Mental health disorders including depression and anxiety are more common among perinatally; HIV-infected adolescents vs those who are not infecting. Adolescents infected with HIV have a greater risk for psychiatric hospitalizations compared with those not infected with HIV.
A large cohort study found that 61% of perinatally-exposed youth (both infected and uninfected); had psychiatric disorders other than substance use. Among HIV-positive adolescents involved in a 2000 US study; 53% was diagnosing with psychiatric disorders and 44% had chronic depression.
High rates of depression have also been observing in HIV-infected children and adolescents in Kenya (17.8%); Malawi (18.9%), and Rwanda (25.0%). There is a need for research comparing HIV-infected youth with other groups such as perinatally-exposed; but uninfected youth and matched controls with no history of exposure.
Mental health problems
Some studies suggest a higher prevalence of mental health problems in female vs male HIV-infected youth; although results was mixing overall. Mental health issues may interfere with indicators of successful transition from pediatric to adult care; such as taking ownership of medical care and adhering with medication and clinic visits.
In general, there are few mental health treatment facilities devoted to children and adolescents. In the Adolescent Impact Study conducted in 3 US cities (n=164); 31% of HIV-infected adolescents demonstrated psychopathology. However, nearly one-third of the patients reporting clinical symptoms; but did not receive care despite the availability of psychiatric medications, hospitalizations, counselling, or psychotherapy. Treatment access may be even lower for marginalized populations; with one study showing that black HIV-infected youth; were less likely to receive mental health care than non-black youth.