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PRIORITY PRESS - 19th Annual Canadian Conference on HIV/AIDS Research (CAHR)

Saskatoon, Saskatchewan / May 13-16, 2010

As discussed by investigators under lead author Dr. Anita Rachlis, Professor of Medicine, University of Toronto, Ontario, management of antiretroviral (ARV)-related symptoms is a major challenge in the treatment of HIV infection; uncensored reporting by the patient and subsequent acknowledgement by the physician are critical. Results from BEAHIV (Behaviour and Attitudes in HIV), a recent Canadian study, demonstrated a low level of agreement between patients and physicians when it came to recognizing the presence of common HIV symptoms. When both patients and physicians reported that the symptoms were discussed, there was more agreement in symptom recognition.

BEAHIV Survey

BEAHIV was a non-interventional, single-visit study that was carried out at 17 sites across Canada. Surveys were completed by the patient and his or her physician during a routine visit at one time point. The patient survey consisted of a number of components but only results from the HIV Symptom Distress Module (SDM) were reported here. As noted by Dr. Marianne Harris, Medical Research Advisor, St. Paul’s Hospital AIDS Research Program, Vancouver, British Columbia, here at CAHR, patients were asked to indicate whether they had experienced any of the symptoms listed on the SDM and the degree to which they found the symptom bothersome and whether they had discussed the symptom with their physician during the clinic visit. “Physicians completed a modified form of the HIV SDM,” Dr. Harris added, “and they were also asked whether they had discussed symptoms at the clinic visit [and the degree to which it bothered the patient].”

A total of 42 physicians participated in the survey—a “highly experienced group,” as characterized by Dr. Harris— with 83% of them indicating they had more than 100 HIV-positive patients in their practice. The mean length of time physicians had been treating patients was 15 years. Patients were mostly men, mean age 46 years, the great majority of whom were born in North America. Seventy-nine per cent of patients had been on antiretroviral therapy (ART) for over three years and over half had been on their current treatment for more than three years. A total of 1000 matched physician-patient surveys were collected between September and November 2009.

Total SDM Score

Out of a total SDM score of 84, the median total SDM score reported by patients was 32.5 vs. 10 by physicians. For individual symptoms, fatigue was the most common, reported as present by 75.8% of patients. In contrast, only 35.5% of physicians documented the presence of fatigue for the same patients. There were 34.5% of patients who also reported that the fatigue they experienced was bothersome compared with 11% of physicians. Sixty-seven per cent of patients indicated they experienced feelings of being “sad, down and depressed” with 25.4% having indicated that these feeling bothered them. From the physician survey, 26.1% of physicians indicated that the symptoms of being “sad, down and depressed” were present and only 7.1% of physicians felt that these feelings were bothersome to their patients. A similar number of patients (66.8%) also indicated they felt nervous or anxious and 23.2% were bothered by these feelings. Twenty-five per cent of physicians indicated that patients were feeling nervous or anxious but only 6.6% of them felt these feelings were bothersome to the patient.

“Patterns were pretty similar for all of the symptoms on the SDM,” Dr. Harris reported. The greatest discordances between patient and physician-reported symptoms were trouble remembering, sexual problems, bloating, pain and gas. The “best pick-up” was for gynecological problems, she added. Dr. Harris indicated that the “good news” was that if both patient and physician agreed they had discussed the symptom, there was much less discordance between patient and physician.

As she also noted, there are many possible explanations for the apparent discordance identified on the survey, including the fact that the patient might have discussed symptoms with another member of the health care team but not the physician; the possibility that patients had discussed the symptom during some other visit, just not this one; the fact that if the symptom was not assessed, it was considered to be absent; and that the survey took into account discussion of symptoms during a single visit at a single time point.

“This was a fairly robust study with 1000 matched patient-physician surveys so I think the good news is that in most cases where the symptom was bothersome, physicians are picking it up,” Dr. Harris told delegates. “But the data do raise additional questions and we need to look further for ways to optimize communication between patients and their physicians.

Optimizing Communication

In a role-playing video presentation of patient-physician-pharmacist interactions here at CAHR, Dr. Harris and colleagues demonstrated how physicians can sometimes override patient concerns about treatment-related side effects, concentrating instead on how good a patient’s numbers are in terms of viral load and CD4 cell counts. Patients themselves also can put up barriers to communication in the mistaken belief that ART is always associated with side effects, that there is nothing they can do to minimize side effects and that, most importantly, if they switch their ART regimen too soon, they may deplete all their options and have nothing left to switch to.

“It has to go both ways—both the physician and the patient have to be proactive and ask questions,” Dr. Harris emphasized in an interview. For example, patients may understand that if treatment is not working well, physicians will have to switch them to another regimen because they have developed resistance to the current one. But patients also need to know that they can still switch from one agent to another if they are not tolerating treatment well because if it is effective, there is no resistance and they can go back to the original therapy if necessary in the future. “A lot of patients want to stay on their first regimen as long as possible because they fear they will not have any options left if they switch but physicians have to explain to them that this is not the case,” Dr. Harris advised.

She remarked that patients need to have “realistic expectations” about HIV care. “These are potent medications and patients are taking at least three of them, so it is pretty unlikely that a patient is going to have zero side effects,” she noted. Importantly, however, patients do need to know that some of these side effects can be managed quite effectively with specific home care strategies, while others are cause for true concern and their physician needs to be alerted right away if they do occur.

Simplifying Treatment Options

Simplification of the ART regimen can also help improve quality of life for patients. Pierre Giguère, Director, Orbicom Research Projects, Montreal, Quebec, cited the ODIN (Once-daily DRV in Treatment-experienced Patients) study presented by Cahn et al. at this year’s annual meeting of CROI. Results from the phase IIIb randomized, open-label study comparing the efficacy, safety and tolerability of ritonavir-boosted darunavir (DRV/r 800/100 mg) given once a day vs. DRV/r (600/100 mg) given twice a day showed that 72% of treatment-experienced patients on the once-daily regimen and 71% of those on twice-daily regimen achieved a viral load of <50 copies/mL at week 48. Median increases in CD4 cell counts were similar at approximately 100 cells/mm3 in each arm and only one patient developed a primary protease inhibitor mutation at week 48. Importantly from a longer-term perspective, the incidence of lipid elevations with once-daily DRV/r was approximately half that seen with the twice-daily regimen.

Investigators concluded that findings support the use of once-daily DRV in treatment-experienced HIV-infected adults provided they have no resistance mutations to the agent on treatment initiation.