This Week in HIV Research: Let's Get Real About Treatment Efficacy

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Many of the research findings that have formed the pillars of our HIV treatment evolution since the 1980s were derived from well-constructed and tightly controlled studies, in which potential participants were excluded based on any of a host of factors. These restrictions are critical characteristics: They allow us to remove background noise and assess the true safety and efficacy of our treatment options and strategies. But they also often leave a critical question answered: How well will this treatment truly work in the real world?

Most of our featured studies this week seek to answer that question across a range of important topics, including:

  • The efficacy of modern-era antiretroviral regimens in real-world settings as opposed to phase 3 trials.
  • The correlation between parent-child communication about HIV and pre-exposure prophylaxis (PrEP) awareness among adolescent men who have sex with men.
  • The feasibility of immune-checkpoint inhibitors as cancer therapy in people receiving HIV treatment.
  • The relationship between AIDS-defining illness history and mortality risk among people diagnosed with cancer.

Read on, and let's get real about each of these study findings. To beat HIV, you have to follow the science!

Barbara Jungwirth is a freelance writer and translator based in New York. Follow Barbara on Twitter: @reliabletran.

Myles Helfand is the executive editor and general manager of TheBody and TheBodyPRO. Follow Myles on Twitter: @MylesatTheBody.

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Real-World Treatment Efficacy High, But Falls Well Short of Clinical Trials

The efficacy of initial antiretroviral therapy regimens in real life is lower than that shown in phase 3 trials, with post-2010 regimens failing in >20% of people over three years, a systematic review published in AIDS showed.

Researchers compared data from 181 studies published between 1994 and mid-2017 comprising a total of 77,999 participants. Mean intention-to-treat efficacy increased with newer regimens; for instance, looking at 144-week results, efficacy averaged 77.1% among studies published after 2010, compared to 61.8% overall. The corresponding numbers for week-48 results were 83.8% among studies published after 2010 compared to 71.3% overall.

Integrase inhibitor- and tenofovir-based regimens predicted greater efficacy at all time points. Resistance genotyping before treatment and once-daily antiretroviral treatment also predicted viral control at week 48.

To further increase real-world regimen efficacy, study authors recommended that initial regimens not based on integrase inhibitors be listed as non-preferred in guidelines, access to pre-antiretroviral genotyping be improved, and early start of once-daily treatment be increased. They also called for collecting socioeconomic data during clinical trials, conducting longer post-approval studies, and incorporating real-world data into guideline development, among other recommendations.

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Parental Communication Associated With PrEP Awareness Among Adolescent MSM

Adolescent men who have sex with men (AMSM) in the U.S. are more likely to know about PrEP when their parents often talk to them about HIV, a 2015 survey published in Journal of Acquired Immune Deficiency Syndrome found.

Sixteen percent of the 636 AMSM who participated in the survey said they were aware of PrEP, and 0.5% reported taking it. More frequent parent communication about HIV was associated with greater odds of knowing about PrEP (odds ratio = 1.45). Among the 104 participants who were already familiar with this biomedical prevention method, those who thought their parents were open, honest, knowledgeable, and trustworthy felt more positively toward PrEP and reported higher perceived behavioral control for its use.

While parental communication improved both knowledge of and readiness to take PrEP, such engagement may not be feasible for all AMSM, study authors acknowledged. They called for further research into where children get their information and how exactly parents influence the way in which their sons learn about and form opinions on sexual health innovations.

Bristol-Myers Squibb Company

Immunotherapy Feasible in People With HIV and Cancer

Treating HIV-positive cancer patients with PD-1/PD-L-1 immune-checkpoint inhibitors is feasible and will not interrupt antiretroviral therapy, a small French study presented at the European Society of Medical Oncology Conference in Munich, Germany, and published in Annals of Oncology showed.

These cancer drugs target the same system that is affected by HIV, a related press release explained, noting that people living with HIV (PLWH) are at increased risk of developing a range of cancers.

The study found that 17 of 20 people treated with the PD-1 inhibitor nivolumab had an undetectable viral load, and two more had a viral load of less than 40 copies/mL. Median CD4 cell count at diagnosis was 338.5 cells/mm3. CD4 cell count and viral load worsened in only one participant, and that occurred only after that person interrupted HIV treatment. Response to the cancer drug appeared comparable to that of people treated similarly who do not live with HIV.

PLWH treated with anti-PD-1 inhibitors should continue antiretroviral treatment, have their CD4 cell count and viral load monitored, and be included in dedicated clinical trials, study authors concluded.

History of AIDS-Defining Illness Increases Mortality Risk in Lung Cancer Patients

PLWH who had a history of AIDS-defining illness (ADI) at the time they were diagnosed with cancer had higher mortality rates than those without such a history, a data analysis published in Journal of Acquired Immune Deficiency Syndrome found.

Thirty-nine percent of 814 participants had an ADI before their cancer diagnosis. The most common cancers were of the lung (55%), anus (20%), and oropharynx (14%), as well as Hodgkin lymphoma (11%). With 96% of participants male, cervical cancer was rare (0.6%). Cancer stage at diagnosis did not differ based on ADI status.

For each cancer, the mortality rate per 1,000 person-years was higher for those with a prior ADI compared to those without such a history. However, that difference only reached statistical significance for lung cancer, where the adjusted mortality rate ratio was 1.6 (compared to 1.0 without an ADI).

Given current HIV treatment recommendations, fewer PLWH may have an ADI history when they are diagnosed with cancer, study authors noted. They called for monitoring the effect of immediate HIV treatment on cancer outcomes and mortality.