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BOSTON – Hair is the key to knowing if patients have been taking their HIV antiretrovirals. In fact, hair levels were the strongest independent predictor of virologic control in a major trial of HIV-positive, treatment-naive patients that compared atazanavir, darunavir, and raltegravir-based regimens. Virologic success was similar in all three arms, but the raltegravir regimen was better tolerated than the protease inhibitor arms (Ann Intern Med. 2014 Oct 7;161[7]:461-71).
Because patient self-reporting is notoriously unreliable, the investigators checked hair for adherence. The results for 599 participants followed for a median of 217 weeks were reported at the Conference on Retroviruses and Opportunistic Infections. Hair samples were collected at weeks 4, 8, 16, and then quarterly; concentrations of the three drugs were measured by liquid chromatography-tandem mass spectrometry.
Rates of virologic failure were 26%, 6%, and 3% for patients with hair levels in the lowest, middle, and highest tertiles, respectively. Lower hair antiretroviral (ARV) levels strongly predicted virologic failure (hazard ratio for every twofold decrease in hair level 1.69, 95% confidence interval, 1.43-2.04, P less than .001). Results were consistent across drugs and for each drug individually.
Patients with ARV hair levels in the lowest tertile were 6.8 times more likely to fail than were patients in the highest tertile. The actual level that was considered low depended on the drug.
Meanwhile, self-reported adherence – a median of 100% in each arm – barely correlated with actual ARV levels (Pearson’s r 0.15).
In the end, “hair levels were the strongest independent predictor of how you did,” said lead investigator Monica Gandhi, MD, associate chief of the Division of HIV, Infectious Diseases, and Global Medicine at the University of California, San Francisco, General Hospital.
Testing for hair levels is already a part of clinical care at UCSF, which has a hair analysis lab. In one case, a 21-year-old man seroconverted after saying he was taking pre-exposure prophylaxis (PrEP) perfectly. After a check of his hair, it turned out that he was, but had caught a drug-resistant virus. Another patient who seroconverted on PrEP turned out to have missed some doses a few months before.
Ideally, hair testing could be used early on to provide extra help to patients who prove to have trouble with adherence. Text messaging – as long as the doctor actually responds – is effective, but so is just bringing people in and asking them how they needed to be helped, Dr. Gandhi said.
All that’s required for testing is a small bit of hair from the back of the head, cut close to the scalp. It’s easy and quick, but even so, acceptance was only 55% in the trial. “Where it seems to not be accepted in this country is in men who have sex with men.” Sometimes patients worry about their hairstyle, but “it isn’t very disruptive because it’s a very small amount of hair,” she said.
Bleaching is the only hair treatment that seems to affect ARV levels, reducing them. Short hair is fine, but it keeps less of a record over time. In general, “hair levels are more helpful in PrEP than in treatment, because in treatment we need a real time point of care test” for adherence, Dr. Gandhi said; her team has come up with a urine screen for tenofovir that looks promising.
The mean age in the study was 38 years. About a third of the subjects were women, and a third were black. The findings were similar for men and women.
The drugs in the trial were provided by their manufacturers. Dr. Gandhi had no relevant disclosures.
SOURCE: Gandhi M et al. Abstract 24.
BOSTON – Hair is the key to knowing if patients have been taking their HIV antiretrovirals. In fact, hair levels were the strongest independent predictor of virologic control in a major trial of HIV-positive, treatment-naive patients that compared atazanavir, darunavir, and raltegravir-based regimens. Virologic success was similar in all three arms, but the raltegravir regimen was better tolerated than the protease inhibitor arms (Ann Intern Med. 2014 Oct 7;161[7]:461-71).
Because patient self-reporting is notoriously unreliable, the investigators checked hair for adherence. The results for 599 participants followed for a median of 217 weeks were reported at the Conference on Retroviruses and Opportunistic Infections. Hair samples were collected at weeks 4, 8, 16, and then quarterly; concentrations of the three drugs were measured by liquid chromatography-tandem mass spectrometry.
Rates of virologic failure were 26%, 6%, and 3% for patients with hair levels in the lowest, middle, and highest tertiles, respectively. Lower hair antiretroviral (ARV) levels strongly predicted virologic failure (hazard ratio for every twofold decrease in hair level 1.69, 95% confidence interval, 1.43-2.04, P less than .001). Results were consistent across drugs and for each drug individually.
Patients with ARV hair levels in the lowest tertile were 6.8 times more likely to fail than were patients in the highest tertile. The actual level that was considered low depended on the drug.
Meanwhile, self-reported adherence – a median of 100% in each arm – barely correlated with actual ARV levels (Pearson’s r 0.15).
In the end, “hair levels were the strongest independent predictor of how you did,” said lead investigator Monica Gandhi, MD, associate chief of the Division of HIV, Infectious Diseases, and Global Medicine at the University of California, San Francisco, General Hospital.
Testing for hair levels is already a part of clinical care at UCSF, which has a hair analysis lab. In one case, a 21-year-old man seroconverted after saying he was taking pre-exposure prophylaxis (PrEP) perfectly. After a check of his hair, it turned out that he was, but had caught a drug-resistant virus. Another patient who seroconverted on PrEP turned out to have missed some doses a few months before.
Ideally, hair testing could be used early on to provide extra help to patients who prove to have trouble with adherence. Text messaging – as long as the doctor actually responds – is effective, but so is just bringing people in and asking them how they needed to be helped, Dr. Gandhi said.
All that’s required for testing is a small bit of hair from the back of the head, cut close to the scalp. It’s easy and quick, but even so, acceptance was only 55% in the trial. “Where it seems to not be accepted in this country is in men who have sex with men.” Sometimes patients worry about their hairstyle, but “it isn’t very disruptive because it’s a very small amount of hair,” she said.
Bleaching is the only hair treatment that seems to affect ARV levels, reducing them. Short hair is fine, but it keeps less of a record over time. In general, “hair levels are more helpful in PrEP than in treatment, because in treatment we need a real time point of care test” for adherence, Dr. Gandhi said; her team has come up with a urine screen for tenofovir that looks promising.
The mean age in the study was 38 years. About a third of the subjects were women, and a third were black. The findings were similar for men and women.
The drugs in the trial were provided by their manufacturers. Dr. Gandhi had no relevant disclosures.
SOURCE: Gandhi M et al. Abstract 24.
BOSTON – Hair is the key to knowing if patients have been taking their HIV antiretrovirals. In fact, hair levels were the strongest independent predictor of virologic control in a major trial of HIV-positive, treatment-naive patients that compared atazanavir, darunavir, and raltegravir-based regimens. Virologic success was similar in all three arms, but the raltegravir regimen was better tolerated than the protease inhibitor arms (Ann Intern Med. 2014 Oct 7;161[7]:461-71).
Because patient self-reporting is notoriously unreliable, the investigators checked hair for adherence. The results for 599 participants followed for a median of 217 weeks were reported at the Conference on Retroviruses and Opportunistic Infections. Hair samples were collected at weeks 4, 8, 16, and then quarterly; concentrations of the three drugs were measured by liquid chromatography-tandem mass spectrometry.
Rates of virologic failure were 26%, 6%, and 3% for patients with hair levels in the lowest, middle, and highest tertiles, respectively. Lower hair antiretroviral (ARV) levels strongly predicted virologic failure (hazard ratio for every twofold decrease in hair level 1.69, 95% confidence interval, 1.43-2.04, P less than .001). Results were consistent across drugs and for each drug individually.
Patients with ARV hair levels in the lowest tertile were 6.8 times more likely to fail than were patients in the highest tertile. The actual level that was considered low depended on the drug.
Meanwhile, self-reported adherence – a median of 100% in each arm – barely correlated with actual ARV levels (Pearson’s r 0.15).
In the end, “hair levels were the strongest independent predictor of how you did,” said lead investigator Monica Gandhi, MD, associate chief of the Division of HIV, Infectious Diseases, and Global Medicine at the University of California, San Francisco, General Hospital.
Testing for hair levels is already a part of clinical care at UCSF, which has a hair analysis lab. In one case, a 21-year-old man seroconverted after saying he was taking pre-exposure prophylaxis (PrEP) perfectly. After a check of his hair, it turned out that he was, but had caught a drug-resistant virus. Another patient who seroconverted on PrEP turned out to have missed some doses a few months before.
Ideally, hair testing could be used early on to provide extra help to patients who prove to have trouble with adherence. Text messaging – as long as the doctor actually responds – is effective, but so is just bringing people in and asking them how they needed to be helped, Dr. Gandhi said.
All that’s required for testing is a small bit of hair from the back of the head, cut close to the scalp. It’s easy and quick, but even so, acceptance was only 55% in the trial. “Where it seems to not be accepted in this country is in men who have sex with men.” Sometimes patients worry about their hairstyle, but “it isn’t very disruptive because it’s a very small amount of hair,” she said.
Bleaching is the only hair treatment that seems to affect ARV levels, reducing them. Short hair is fine, but it keeps less of a record over time. In general, “hair levels are more helpful in PrEP than in treatment, because in treatment we need a real time point of care test” for adherence, Dr. Gandhi said; her team has come up with a urine screen for tenofovir that looks promising.
The mean age in the study was 38 years. About a third of the subjects were women, and a third were black. The findings were similar for men and women.
The drugs in the trial were provided by their manufacturers. Dr. Gandhi had no relevant disclosures.
SOURCE: Gandhi M et al. Abstract 24.
AT CROI
Key clinical point: Hair is a solid alternative to blood, urine, and self-report for HIV drug adherence.
Major finding: Virologic failure was 6,8 times more likely among subjects with antiretroviral hair levels in the lowest tertile, compared with those in the highest tertile.
Study details: Phase 3 trial with 599 subjects.
Disclosures: The drugs in the trial were provided by their manufacturers. The lead investigator had no relevant disclosures.
Source: Gandhi M et al. Abstract 24.
