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National Association of Managed Care Physicians Fall Forum 2019

Implementing Rapid and Effective ART Initiation to Successfully Manage HIV

Jaime Rosenberg
Mary Montgomery, MD, associate physician in the Division of Infectious Diseases at Brigham and Women’s Hospital, and an instructor of medicine at Harvard Medical School, discussed emerging treatment strategies for managing HIV during a session at the National Association of Managed Care Physicians 2019 Fall Managed Care Forum, held October 10-11 in Las Vegas, Nevada.

When choosing the first-line treatment for patients diagnosed with HIV, it may seem like there are endless options, but it’s important to factor in several considerations to find which regimen works for which patient, such as preference for multiple pills versus single-tablet regimens, barrier to resistance, food requirement, drug–drug interaction, and medical comorbidities, said Montgomery.

Among the options recommended by HHS for initial treatment, there are 2 that Montgomery uses often in clinical practice: Biktarvy (bictegravir/emtricitabine [FTC]/tenofovir alafenamide [TAF]) and dolutegravir (DTG).

Biktarvy is a once-daily, single-tablet regimen that includes the novel, unboosted INSTI bictegravir and is indicated for both patients with HIV-1 ribonucleic acid (RNA) <50 copies/mL for at least 3 months with no history of treatment failure and no treatment resistance, as well as for treatment naïve patients.

Both Biktarvy and DTG have a high barrier to resistance.

Montgomery noted concerns that have surrounded DTG since May 2018, when data came out that the treatment was associated with neural tube defects, with an increased rate of just under 1.00% (0.90%). However, additional data recently coming from Botswana and Brazil found that, among the larger population, the risk was considerably lower (0.30%). For Montgomery, the decision to prescribe DTG is made on a case by case basis.

More recently, 2 randomized clinical trials pointed to significant weight gain associated with treatment with DTG when combined with TAF. In the NAMSAL trial, which included 613 ART-naïve patients with HIV-1 RNA >1000 c/mL in Cameroon, patients received either dolutegravir or efavirenz, both combined with the older formulation of tenofovir disoproxil fumarate (TDF) and lamivudine.

In the ADVANCE trial, which included 1053 ART-naïve patients with HIV-1 RNA >500 c/mL in South Africa, researchers compared the combination of DTG plus TAF/FTC with DTG plus TDF/FTC and EFV/TDF/FTC.

While both trials demonstrated that DTG was noninferior to EFV, results did show that there was progressive weight gain and clinical obesity among the participants, particularly in women. In the ADVANCE trial, those receiving DTG plus TAF/FTC exhibited a 19% prevalence of treatment-emergent obesity at week 96.

Based on these findings, there are various questions that are left unanswered, said Montgomery:
  • Why is INSTI use plus TAF associated with weight gain?
  • Why does TAF cause more weight gain than TDF?
  • Is there a difference between INSTIs?
  • Will the trend reverse if the drugs are stopped?
  • Will this weight gain lead to diabetes, metabolic, or cardiovascular risks?
Pilcher CD, Ospina-Norvell C, Dasgupta A, et al. The effect of same-day observed initiation of antiretroviral therapy on HIV viral load and treatment outcomes in a US public health setting [published online January 1, 2017]. J Acquir Immune Defic Syndr. doi: 10.1097/QAI.0000000000001134.

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