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IDCM Issue 3: Updates in HIV for All Providers: Key Studies from the 2016 Conference on Retroviruses and Opportunistic Infections
Natasha Chida, MD, MSPH
The 23rd annual Conference on Retroviruses and Opportunistic Infections (CROI) was held February 22nd-25th, 2016, in Boston, Massachusetts. The conference reviewed critical basic, translational, and clinical HIV research from around the world. The following are a few of many key studies presented at the conference that may be of interest to all providers who see patients with HIV, either as a primary provider or in consultation.
The Centers for Disease Control and Prevention (CDC) estimates that 1 in 96 persons living in the United States (US) will get diagnosed with HIV in their lifetime.1
This CDC study used HIV diagnosis data from the National HIV Surveillance System, mortality data from the National Center for Health Statistics, and population data from the US Census 2009-2013 to estimate the lifetime risk of HIV infection in the US. Key findings of certain groups’ lifetime risks include the following:
- 1 in 62 men and 1 in 221 women will be diagnosed with HIV.
- 1 in 19 black men, 1 in 47 Hispanic men, 1 in 127 white men, and 1 in 174 Asian men will be diagnosed with HIV.
- 1 in 46 black women, 1 in 214 Hispanic women, 1 in 851 white women, and 1 in 883 Asian women will be diagnosed with HIV.
- 1 in 6 men who have sex with men (MSM), 1 in 2 black MSM, 1 in 4 Hispanic MSM, 1 in 11 white MSM, and 1 in 14 Asian MSM will be diagnosed with HIV.
- 1 in 241 heterosexual women and 1 in 473 heterosexual men will be diagnosed with HIV.
- 1 in 23 women and 1 in 36 men who inject drugs will be diagnosed with HIV.
- 1 in 15 persons who are 29 years old and 1 in 55 persons who are 50 years old will be diagnosed with HIV in the next 10 years.
The study shows that certain subgroups of the US population are at greater risk for acquiring a diagnosis of HIV than others. In addition, prevention of new infections is critical in the national fight against HIV. With increased availability and utilization of pre-exposure prophylaxis, we may see these numbers drop.
In newly diagnosed patients with HIV and CD4 counts <50, empiric therapy for active tuberculosis (TB) + antiretroviral therapy (ART) does not have a mortality benefit when compared with empiric latent tuberculosis therapy + ART.2
26% of patients in low and middle income countries who have HIV and who initiate ART die within 1 year, often from TB. In this multi-country randomized controlled trial, ART + empiric 4-drug therapy for active TB was compared with ART + empiric latent TB therapy (INH X 9 months) in newly diagnosed persons with HIV and CD4 counts <50. Patients were screened prior to enrollment for evidence of active TB. The primary outcomes were death, AIDS progression, or confirmed/probable TB at 48 weeks. 850 patients were enrolled; 90% were black and 53% were male. The median CD4 count was 18. No difference was found between the arms in terms of mortality or AIDS progression. Surprisingly, the empiric TB therapy arm had more cases of TB than the latent TB therapy arm at week 48. The authors note these data support enhanced screening for TB prior to ART initiation, and for latent TB treatment in persons with advanced HIV living in high TB burden regions.
More evidence for an intermittent all-injectable HIV treatment regimen.3
2 long acting injectable antiretrovirals (ARVs), carbotegravir (an integrase inhibitor) and rilpivirine (a nonnucleoside reverse transcriptase inhibitor) are under development. This study compared the safety and efficacy of giving these ARVs as intramuscular (IM) injections either every 8 weeks (Q8W) or 4 weeks (Q4W), versus a daily oral regimen of carbotegravir, abacavir, and lamivudine. Patients who were treatment-naïve were enrolled and received carbotegravir, abacavir, and lamivudine for 20 weeks. Those with an undetectable viral load at week 20 were switched to the Q8W IM regimen, the Q4W IM regimen, or were continued on the oral regimen via a 2:2:1 randomization. At 32 weeks, 95% of the Q8W and 94% of the Q4W patients remained undetectable, compared with 91% of those on the oral regimen. The most common adverse reaction for the IM regimens was pain at the injection site (92%). Other adverse reactions included nasopharyngitis (20%), diarrhea (12%) and headache (14%) in IM arms, and nasopharyngitis (25%), headache (7%), and diarrhea (5%) in the oral arm. This study thus found comparable efficacy and rates of side effects among the groups, which supports the continued of this potential all-injectable treatment regimen.
Higher than expected rates of side effects to dolutegravir found in a real-life cohort.4
Integrase inhibitors have become preferred ARVs in countries with access to these drugs. Dolutegravir, in particular, is highly potent, has a high barrier to resistance, and was well-tolerated in trials (<3% adverse reactions). In this study, a group in the Netherlands evaluated 388 patients who were initiated on dolutegravir. Researchers found that 62 (16%) of patients stopped taking dolutegravir after a median of 78 days (range 5-327). Of the treatment-naive patients, 9/65 (13.8%) stopped, while of the treatment-experienced patients 53/322 (16.4%) stopped. Of those who used dolutegravir as a tablet along with other ARV tablets, 24/158 (15.6%) stopped, compared with 38/230 (16.5%) of patients used a single combination tablet of dolutegravir, abacavir, and lamivudine. The majority of the patients who stopped the dolutegravir did so due to intolerance (55/62; 88.7%). Intolerances included: sleeping problems (19/55; 34.5%), gastrointestinal problems (18/55; 32.7%), psychiatric problems (12/55; 21.8%), headache (7/55; 12.7%), and musculoskeletal problems (6/55; 10.9%).
This study found higher than expected discontinuation rates of dolutegravir in a real-life cohort. Patients who are initiated on dolutegravir and who develop these symptoms may be experiencing an intolerance to the drug.
More about this year’s CROI conference, including webcasts for many presentations, can be found online: http://www.croiconference.org/
- Hess K, et al. Estimating the lifetime risk of a diagnosis of HIV infection in the United States. Abstract 52 presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2016; Boston, MA. http://www.croiconference.org/sessions/estimating-lifetime-risk-diagnosis-hiv-infection-united-states
- Johnstone J, et al. Empiric TB therapy versus IPT in HIV-infected persons initiating ART (ACTG A5274 48w). Abstract 745 presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2016; Boston, MA. http://www.croiconference.org/sessions/empiric-tb-therapy-versus-ipt-hiv-infected-persons-initiating-art-actg-a5274-48w
- Margolis DA, et al. Cabotegravir+rilpivirine as long-acting maintenance therapy: LATTE-2 week 32 results. Abstract 31LB presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2016; Boston, MA.http://www.croiconference.org/sessions/cabotegravirrilpivirine-long-acting-maintenance-therapy-latte-2-week-32-results
- Van den Berk G, et al. Unexpectedly high rate of intolerance for dolutegravir in real-life setting. Abstract 948 presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2016; Boston, MA. http://www.croiconference.org/sessions/unexpectedly-high-rate-intolerance-dolutegravir-real-life-setting
The Johns Hopkins Center for Clinical Global Health Education is a clinical research, education, and leadership development center in the Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine. We conduct clinical research, and we train, support, and empower healthcare providers and researchers working in resource-limited communities who share our commitment to improve health outcomes.