This Week in HIV Research: As Pill Burden Drops, Pill Cost Rises
Much like the effects of climate change on global sea levels, it has begun to feel in recent years that the rise of health care costs in the U.S. is an inevitable, ever-increasing tide. It’ll probably come as little surprise to those of you reading this article that HIV treatment has not been magically protected from that sea change. If anything, as our lead story this week makes clear, the opposite is true: The relative cost of antiretroviral therapy is showing no sign of slowing, even as efforts kick into gear that seek to put an end to the U.S. HIV epidemic by 2030—and even as treatment itself grows simpler, requiring fewer pills and smaller doses to achieve and maintain viral suppression.
On tap for us this week in our examination of recently published research on HIV:
- HIV medication costs significantly outpaced the rate of inflation in the U.S. throughout much of the past decade.
- HIV infection later in life may attenuate the effects of childhood smallpox vaccination—a finding with potential implications for other vaccinations a person receives prior to becoming HIV positive.
- Explorations of dolutegravir use among pregnant women in the U.S. reveal little cause for concern—but also reveal challenges to obtaining useful data on how medications can affect pregnancy.
- For the U.S. to end its HIV epidemic, HIV testing programs and other interventions will need to be diligently localized, research suggests.
More on each of these findings is just ahead. To beat HIV, you have to follow the science!
HIV Treatment Costs Are Rising Much Faster Than Inflation in U.S.
After being diagnosed and linked to care, people living with HIV (PLWH) will be taking antiretroviral medications at an ever-increasing price, a research letter in JAMA Internal Medicine notes.
Among well-resourced countries, the U.S. has the highest cost for antiretroviral therapy, but the lowest viral suppression rate (54%), researchers found. Between 2012 and 2018 in the U.S., the average wholesale price of recommended initial treatment regimens increased at 3.5 times the rate of inflation. The price of recommended alternative regimens rose even more, at 5.6 times the rate of inflation.
In 2018, the U.S. spent $22.5 billion on antiretroviral therapy. To achieve the goals of the current U.S. “Plan to End the HIV Epidemic” by 2030, viral suppression rates must increase by a third, raising the total cost of HIV treatment to $35.6 billion.
Average wholesale prices are not what most patients pay out of pocket. However, as PLWH live longer, health insurance companies are trying to manage their cost by various means, including having people who are insured pay a larger share of the price of their treatment. "We provide these details so that physicians can be sensitive to drug costs when recommending initial regimens of similar efficacy because costs borne directly by patients can affect their adherence and engagement in care," study authors explained.
HIV May Reduce Protection Conferred By Childhood Vaccination
Among women who were vaccinated against smallpox as children, the T cells of HIV-positive women who were on successful antiretroviral therapy were much more likely to have lost their “memory” of smallpox than the T cells of HIV-negative women, researchers reported in Journal of Infectious Diseases.
Study authors compared CD4 and CD8 cell antibody responses to vaccinia in 50 women living with HIV and 50 matched HIV-negative controls. Vaccinia is a virus similar to smallpox that was used to inoculate people against smallpox. (Routine vaccinations were stopped in the U.S. in 1972, when the disease was declared eradicated.)
Despite their natural decline over time, detectable vaccinia-specific CD4 T cells were still found in 20% of HIV-negative participants, but only in 2.4% of those living with HIV. CD8 T cell memory remained similar between the two groups.
Participants in the HIV group started antiretroviral therapy at CD4 cell counts < 200 cells/mm3 and saw that count rebound to >350 cells/mm3 after HIV treatment. Other studies have shown better retention of T cell memory in people whose CD4 counts never dip below 350 cells/mm3.
It is unclear whether the observed loss of antibody response is specific to the smallpox vaccine or may affect vaccination-induced protection against other common viruses, such as measles or mumps. The current study did not address the need for re-administering common childhood vaccinations to PLWH, although the data may suggest this, a related press release cautioned.
Study authors called for additional research among people with higher CD4 cell counts, as well as among men.
Researchers Call for Linking Disease Surveillance Programs to Assess Effect of Medications on Pregnancy
New U.S. research appears to affirm recent findings suggesting little cause for concern about a potential link between dolutegravir (Tivicay) use and neural tube defects in infants, but it also highlights systemic obstacles that make it harder to accurately assess such relationships.
After early warnings about dolutegravir and birth defects emerged in Botswana in early 2018, researchers tried to ascertain whether such a link also existed in the U.S. Writing in the Morbidity and Mortality Weekly Report on Jan. 10, the research team reported that during 2013-2017, the rates of neural tube defects in infants born to women living with HIV and in the general population were similar at 7 and 8 per 10,000 live births, respectively. (Dolutegravir was approved in the U.S. in 2013.)
Further refining the data proved extremely difficult, the authors reported. Their research was hampered by the fact that birth defects and HIV status are tracked in two separate registries and pregnancy surveillance differs across jurisdictions. In addition, no data on specific antiretroviral regimens taken were available. Furthermore, 1 in 9 women living with HIV does not know her serostatus and is therefore not included in the HIV registry. While undiagnosed women are not on antiretroviral therapy, they may take other medications that could affect their infants.
The challenges experienced by researchers as they sought answers to their questions have implications that stretch far beyond the relationship between a single antiretroviral and a single birth defect, the authors suggested. "Linkage of data from other surveillance programs might help to assess possible associations between maternal disease or maternal use of medications, and pregnancy outcomes," they concluded.
Localized HIV Testing and Treatment Strategies Needed to Lower Seroconversion Rates
Interventions that are demographically customized within each locality in which they are implemented will be critical to the success of efforts to end the HIV epidemic in the U.S., researchers reported in Morbidity and Mortality Weekly Report.
The current U.S. “Plan to End the HIV Epidemic” (EHE) identifies 50 high-priority jurisdictions. In 2017, programs funded by the U.S. Centers for Disease Control and Prevention in these locations conducted almost 2 million HIV tests and diagnosed 8,154 people who had not previously known their serostatus, study authors found.
Of these diagnoses, 49% were among African Americans, and the same percentage were among people living in the U.S. South. The programs also identified 8,917 people who had been previously diagnosed but were not in care, 59% of whom were African American, 17% were white, and 15% Latinx.
African Americans received HIV testing at twice the rate of whites or Latinos (43% versus 22% of HIV tests). Study authors identified stigma, comorbidities, and socioeconomic inequalities as risk factors for HIV acquisition and barriers to prevention and care, as well as to housing. “To achieve the goals of the EHE initiative, HIV prevention programs will need to focus on locally tailored evidence-based testing strategies to overcome barriers for and enhance linkage to and retention in care, provide prophylaxis and treatment, and reduce onward HIV transmission and HIV-related disparities,” they concluded.