Improving Decision Making in Individualized HIV Treatment

Mary Watson Montgomery, MD, of the Brigham and Women’s Hospital at Harvard Medical School, discussed emerging HIV therapies and how health care decision makers can help patients access high quality HIV care at the NAMCP Spring Managed Care Forum 2018.

Dr Montgomery opened her discussion by reviewing the disease burden of HIV in the United States. She explained that there were 40,000 new cases of HIV identified in the United States in 2016; however, there are 1.1 million people living with HIV and 1 in 7 are not aware they have the disease. Additionally, she explained that there are geographic factors related to HIV disease burden, with 50% of new HIV infections identified in southern states. Southern states, along with New York, New Jersey, Maryland, and Delaware, also have the highest risk for HIV infection. 

According to Dr Montgomery’s presentation, HIV disproportionately affects men who have sex with men (MSM), with a 1 in 6 lifetime risk for infection among this patient population—compared with 1 in 241 for heterosexual women and 1 in 473 for heterosexual men. Further, the risk increases for MSM in minority populations, with a lifetime risk of 1 in 2 for black MSM and 1 in 4 for Hispanic MSM—compared with 1 in 11 for white MSM.

She explained that with the emergence of new therapies, testing positive for HIV is no longer a death sentence for patients and can be maintained as a chronic condition. Dr Montgomery cited evidence showing that in a well-maintained patient population treated with antiretroviral therapy, mortality rates among patients with HIV were the same as the general population. However, she noted that management of HIV has not yet completely reduced the mortality burden associated with HIV infection—with HIV positive patients living 13 years less than HIV negative patients in 2016. 

Among the emerging treatments for HIV, Dr Montgomery highlighted the newest single tablet regimen—Biktarvy (Bictegravir/FTC/TAF; Gilead). She explained that the drug is a once-daily single tablet regimen with novel, unboosted integrase strand transfer inhibitors (INSTI). The regimen is indicated for treatment-naïve patients and patients with HIV‐1 RNA < 50 copies/mL for ≥ 3 months with no history of treatment failure and no resistance to the regimen. 

Dr Montgomery explained that individualized treatment of HIV requires providers to consider many factors when choosing an INSTI regimen. These include the use of a multiple pill regimen vs a single-pill regimen, barriers to resistance, food requirements for treatments, drug-to-drug interactions, and medical comorbidities. 

Dr Montgomery also highlighted the recently approved two-drug therapy Juluca (dolutegravir/rilpivirine; ViiV). She explained that this single-tablet regimen is the first two-drug combo approved by the FDA. The treatment is not indicated for naïve patients, only patients who have had virological suppression for more than 6 months. Juluca must also be taken with a meal.

Dr Montgomery also reviewed when patients should be switched to a new drug regimen. She explained that patients can be switched when the pill burden is hurting adherence, when side effects are troubling the patient, when patients begin taking new drugs that may react with their current regimen, and when there are medical comorbidities to consider. 

During the presentation, Dr Montgomery also highlighted some therapies in the drug-approval pipeline that could soon impact management of HIV. She explained that doravirine (Merck) is a next generation NNRTI that is taken once-daily and has no food requirement. Another agent, MK‐8591 (Merck), is currently in phase 2 trials, according to Dr Montgomery. She also noted that treatments with new delivery methods could soon come to the market in the form of injectables.

Dr Montgomery concluded by emphasizing that patients with HIV need affordable therapies and high quality care. She said this can be achieved through access to a social worker or AIDS service organization that can help connect patients with insurance coverage, patient assistance programs, dental programs, and decrease stigma. She also noted that these patients need access to substance use disorder screening and treatment, preventative care, and smoking cessation services. 

—David Costill