Friday, December 5, 2014

Fighting an Uphill Battle': Experience With the HCV Triple Therapy

Fighting an Uphill Battle': Experience With the HCV Triple Therapy
What support is needed for patients undergoing the burdensome HCV triple therapy?

Available @ Medscape:
Fighting an Uphill Battle': Experience With the HCV Triple Therapy
Qualitative Thematic Analysis
Manuela Rasi, Patrizia K├╝nzler-Heule, Patrick Schmid, David Semela, Philip Bruggmann, Jan Fehr, Susi Saxer, Dunja NiccaDisclosures
BMC Infect Dis. 2014;14(507)
December 05, 2014 

Discussion Provided Below

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This thematic analysis provides insights into HCV patients' experiences with PI based triple therapy. Before beginning their therapy, these patients were powerfully motivated to improve their health and achieve a cure. For dual therapy, patients have associated concerns regarding disease progression, loss of liver function and other potential health problems with treatment initiation.[43,44] However, this study group's homogeneously high motivation might not reflect the attitude of the majority of HCV patients in need for treatment. Studies have shown that large proportions of patients (10% - 44%) undergoing dual therapies typically discontinue treatment.[15,43,45] Although we included participants from three different outpatient clinics and used maximum variation sampling to ensure diverse characteristics and living circumstances, there might have been an earlier clinical selection of highly motivated patients treated with the then-newly-available triple therapies and the next generation of interferon-free treatments.

Soon after starting triple therapy, our highly-motivated study group found themselves struggling. The constitutive theme–"Fighting an uphill battle"–describes the patients' common existential experience of coping with the therapy's side effects and indirect negative consequences. Bell et al. describe similar existential treatment experiences among cancer patients receiving adjuvant chemotherapy.[46] However, in contrast to cancer patients, who saw their symptoms as a means of tracking treatment effectiveness and increasing the possibility of remission, this study's HCV patients indicated beliefs congruent with research on triple therapy, i.e., that it numerous side effects, including possible life threatening adverse events, are to be expected, but that no associations exist between symptoms and success.[18,47]

In this study, despite information from healthcare providers and research oriented treatment reports, the symptoms experienced surpassed the patients' expectations (as described in the "Encountering surprises" subtheme). Across chronic conditions, high symptom numbers, high symptom distress and low perceived symptom manageability have negative impacts on health outcomes including quality of life and medication adherence.[48,49] Given the high number of HCV patients who commonly interrupt dual therapy and the high symptom burden of triple therapy, it can be hypothesized that mitigating patient distress via early symptom management support will increase successful completion of therapy and would decrease dropout rates in less persistent patient groups. And while even healthcare providers were occasionally surprised by the severity and diversity of the new treatment's side effects, the first step of effective symptom management is to assess patients' perceptions of their symptoms.[50] However, our records illustrate very clearly that the participants' symptom experiences were often so foreign to them that only metaphoric language was sufficient to explain them. Therefore, standard biomedical symptom assessment by health care providers might not be sufficient to capture the details of symptoms or symptom clusters that impact safety, adherence and treatment persistence. And with the prospect of HCV treatment options appearing in the near future, a proactive and patient-oriented system of symptom assessment will remain an important component of clinical HCV management. On the one hand these treatments are expected to entail fewer and less severe adverse events; on the other, they will also be used in patients in advanced stages of the disease, suffering co-morbidities and living in more complex circumstances.
As described above in the subtheme "Reaching the limits of systems" the therapy's drastic physical and emotional effects fundamentally disrupted participants' everyday lives and severely limited their social interactions. Similar phenomena have been described for symptomatic but untreated HCV patients, as well as for other chronic conditions.[51]

However, the radical social changes described by our study participants appeared heavily influenced by their fear of stigmatization. In order to protect themselves from negative social consequences, it is common for patients with stigmatized infectious diseases such as HIV and HCV to make careful disclosure decisions and in some cases conceal their conditions as fully as possible.[52–54] Our illness-experienced study group described a range of selective disclosure management strategies that had apparently been effective before the start of their triple therapy. During treatment, though, the sudden appearance of visible symptoms led to isolation when support was most needed. In some cases, though, the perception of societal rejection might simply have been internalized, i.e., the fear of stigmatization may have led some to project it onto those around them. Recent evidence shows promising approaches to combatting internalized stigma (self-stigmatization) by improving both self-esteem and help-seeking behavior.[55,56] To minimize stress and improve social support during HCV treatment, healthcare providers should discuss stigmatization fears and disclosure management strategies during consultations both before and during treatment.

The importance of social support is also apparent in the "Reaching the limits of systems" subtheme. Participants recalled both how their symptoms sometimes impaired their judgment and how, during these periods of diminished capacity, the support of family members and close friends was crucial. The positive effects of social support on chronically ill patients' health outcomes is well documented. For example, for patients living with HIV and receiving antiretroviral treatment, a stable partnership is associated with a slower progression to AIDS or death;[57] and among patients living with HCV, those who are married are more likely to complete dual therapy.[43] In addition to companionship, close social contact is known to have multifaceted benefits, including emotional, instrumental, informational support.[34,58,59]

Since study patients revealed problems with judgment and efficacy concerning sometimes life threatening symptoms, a sound knowledge of HCV treatment and decision making skills is important not only for patients but for their close support persons. This requires healthcare providers to identify close support persons and integrate them into patient education programs. Where social contact with support persons is limited, professional support, e.g., community care, should be intensified.
Based on current evidence and clinical expertise, difficulties in adherence with the complex triple therapy regimens are to be expected.[18,28,59] Surprisingly, this study's patients did not raise the issue of medication management. However, as some patients mentioned difficulties when asked, adherence issues may simply have been eclipsed by the intensity of the medications' side effects. Given that heavy symptom burdens (often much lighter than those described by this study's patients) are known to impact adherence, and that poor adherence to dual therapy is known to impact virological response,[25–27] it is important to integrate non-judgmental adherence assessment into routine clinical care.

The insights provided by this study illustrate the need to assess patient perspectives of new treatment options in 'real-life' settings–as opposed to those of clinical trials. In clinical care, clinicians routinely treat patients who would have been excluded from clinical trials due to medical, social or behavioral problems. Research shows that exactly such medical or socio-behavioral challenges impair results in patients with HCV.[42,60,61] Therefore, despite the availability of new HCV treatment options, it remains important to assess patients' treatment experiences with various other regimens where, based on information from clinical trials, these treatments offer higher tolerability and manageability. Furthermore, considering the extremely high cost of the currently-available IFN-free regimes with improved tolerability, it can be expected that they will not be used in all countries.

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