Treat Early or Wait and Monitor? A Qualitative Analysis of Provider Hepatitis C Virus Treatment Decision-Making in the Context of HIV Coinfection

Article (PDF Available)inAIDS patient care and STDs 23(9):715-25 · September 2009with14 Reads
DOI: 10.1089/apc.2009.0049 · Source: PubMed
Abstract
Liver disease is a leading cause of death among patients with HIV coinfected with hepatitis C (HCV); yet, studies show that less than 10% receive HCV treatment, in part because of limited treatment response, high treatment toxicity, and psychosocial barriers to treatment readiness. Using a process model framework, we sought to explore the factors and processes by which providers make HCV treatment decisions for HIV-coinfected patients. We conducted 22 semistructured interviews with primary care providers and support staff at three HIV clinics in Los Angeles, California, in which rates of HCV treatment uptake varied from 10% to 38%. Providers agreed that stable HIV disease, favorable genotype, and significant signs of liver disease progression are all signs of need for treatment. However, two divergent treatment approaches emerged for genotype 1 and 4 patients with minimal disease, and in definitions of patient readiness. Providers with lower treatment rates preferred to delay treatment in hopes of better future treatment options, and were more conservative in requiring complete mental health screens and treatment and abstinence from substance use. Conversely, providers with higher treatment rates viewed all patients as needing treatment as soon as possible, and defined readiness more leniently, with some willing to treat even in the context of untreated depression and drug use, so long as ability to adhere well was demonstrated. Regardless of whether an aggressive or cautious approach to treatment is used, development of effective programs for promoting patient treatment readiness is critical to ensuring greater treatment uptake.
ORIGINAL ARTICLE
Treat Early or Wait and Monitor? A Qualitative Analysis
of Provider Hepatitis C Virus Treatment Decision-Making
in the Context of HIV Coinfection
Glenn Wagner, Ph.D.,
1
Gery Ryan, Ph.D.,
1
Karen Chan Osilla, Ph.D. ,
1
Laveeza Bhatti, Ph.D., M.D.,
2
Matthew Goetz, M.D.,
3
and Mallory Witt, M.D.
4
Abstract
Liver disease is a leading cause of death among patients with HIV coinfected with hepatitis C (HCV); yet, studies
show that less than 10% receive HCV treatment, in part because of limited treatment response, high treatme nt
toxicity, and psychosocial barriers to treatment readiness. Using a process model framework, we sought to explore
the factors and processes by which providers make HCV treatment decisions for HIV-coinfected patients. We
conducted 22 semistructured interviews with primary care providers and support staff at three HIV clinics in Los
Angeles, California, in which rates of HCV treatment uptake varied from 10% to 38%. Providers agreed that stable
HIV disease, favorable genotype, and significant signs of liver disease progression are all signs of need for
treatment. However, two divergent treatment approaches emerged for genotype 1 and 4 patients with minimal
disease, and in definitions of patient readiness. Providers with lower treatment rates preferred to delay treatment
in hopes of better future treatment options, and were more conservative in requiring complete mental health
screens and treatment and abstinence from sub stance use. Conversely, providers with higher treatment rates
viewed all patients as needing treatment as soon as possible, and defined readiness more leniently, with some
willing to treat even in the context of untreated depression and drug use, so long as ability to adhere well was
demonstrated. Regardless of whether an aggressive or cautious approach to treatment is used, development of
effective programs for promoting patient treatment readiness is critical to ensuring greater treatment uptake.
Introduction
N
early 30% of HIV-positive Americans are coinfected
with hepatitis C (HCV),
1
and with HIV antiretroviral
therapy (ART) extending the life of people living with HIV,
end-stage liver disease is now a leading cause of death in this
population.
2,3
Studies show that a majority of coinfected pa-
tients have at least moderate liver inflammation or other signs
of disease progression,
4,5
however, several studies published
over the past 5 years have shown that less than one third of
HIV coinfected patients in the United States are deemed eli-
gible for HCV treatment, and under 10% actually receive
treatment.
6–12
Despite the apparent discord between the need
for more aggressive HCV clinical management and the low
treatment rates that are generally observed, few studies have
examined the treatment decision-making of providers of HIV-
coinfected patients.
The relatively low efficacy and high toxicity of HCV treat-
ment undoubtedly contribute to the low treatment uptake.
Rates of sustained viral response (SVR) or a ‘cure’ have im-
proved with the advent of pegylated-interferon (PEG-IFN) in
combination with ribavirin (RBV), but still remain limited
with rates ranging from 27%–45% among HIV coinfected
patients
13–16
; rates are even lower among genotype 1 patients
at 17%–38%, who represent the vast majority of the patients in
the United States. New treatment agents (e.g., protease and
polymerase inhibitors) that may improve treatment efficacy
are at various stages of development and testing, but are not
expected to be available for routine practice for at least a few
years and interferon will remain a component of treatment.
17
HCV treatment is considered highly burdensome with flu-like
symptoms (nausea, diarrhea, weight loss), fatigue associated
with hematologic abnormalities (anemia, neutropenia), and
neuropsychiatric symptoms (depression, irritability) being
1
RAND Corporation, Santa Monica, California.
2
AIDS Healthcare Foundation, Los Angeles, California.
3
Greater Los Angeles Veterans Administation, Los Angeles, California.
4
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California.
AIDS PATIENT CARE and STDs
Volume 23, Number 9, 2009
ª Mary Ann Liebert, Inc.
DOI: 10.1089=apc.2009.0049
715
highly prevalent,
18
and dropout rates as high as 40%–50% in
community samples of coinfected patients.
14,19,20
Conversely,
proponents of HCV treatment can argue that PEG-IFN=RBV,
unlike ART, has a limited duration and at least a chance of a
cure.
Although HCV treatment guidelines for HIV coinfected
patients have been published,
21
there remains a lack of
consensus and variable expert opinion with regard to several
key factors. Stage of disease with regard to both HIV and
HCV is thought to play a leading role in influencing pro-
vider decisions about whether to recommend HCV treat-
ment. Patients with genotype 2 or 3 are typically thought to
be good treatment candidates as long as the liver disease is
not too advanced because of the high treatment success rate
among these patients.
13–16
Among genotype 1 and 4 pa-
tients, HCV treatment has generally been recommended for
patients with at least moderate signs of fibrosis and in-
flammation of the liver; however, some recommend that
coinfected patients with minimal or no fibrosis should also
be considered for treatment.
22
Late stage, decompensated
liver disease and advanced immunosuppressiona (i.e., low
CD4 count) are common reasons for coinfected patients
being excluded from HCV treatment,
7
and HCV treatment
has been shown to be more successful among HIV patients
with higher CD4 counts and milder liver disease.
23–25
This
suggests the need to closely monitor patients and to initiate
treatment prior to both HCV and HIV disease becoming too
advanced. Nonetheless, studies of coinfected patients reveal
high rates (55%–84%) of advanced liver disease upon onset
of HCV treatment.
26
Provider perception of a patient’s readiness to tolerate and
adhere to treatment also plays a major role in treatment de-
cision making. Poor clinic attendance and nonadherence to
ART are seen as proxies for readiness to adhere to HCV
treatment and as justification to defer treatment.
7,27
Substance
abuse and mental illness each account for 20%–30% of coin-
fected patients being deemed ineligible for treatment, as cli-
nicians are concerned that the side effects of HCV treatment
may lead to psychiatric deterioration, relapse into substance
abuse, poor adherence, and treatment discontinuation.
6–8,27,28
Psychiatric and substance abuse patients have been excluded
from most clinical trials, but the little data available show
mixed results; some studies find that such patients do equally
as well in terms of ability to complete and respond to treat-
ment,
29–31
while others suggest that patients with active
substance abuse and psychiatric problems are less likely to
respond and more likely to drop out of treatment.
32,33
Characteristics of the provider and clinic organization can
also influence HCV treatment decisions. Unlike HCV mono-
infected patients, who are typically treated by liver specialists
(e.g., hepatologist or gastroenterologist) with extensive ex-
perience with HCV treatment, HIV coinfected patients are
most often treated by HIV primary care providers (with rel-
atively limited experience with PEG-IFN=RBV) because liver
specialists are unavailable. Aside from medical discipline and
amount of experience with HCV treatment, other provider
characteristics that may influence treatment decisions include
provider attitudes towards the efficacy, burden level, and
urgency of HCV treatment. Organizational factors include the
availability of a liver specialist either as the primary HCV care
provider or as a consultant, the use of specialty subclinics
devoted specifically to HCV care, clinic policies or guidelines
for determining HCV treatment candidates, and access to
mental health and substance abuse specialists.
In this report, we document findings from semistructured,
qualitative interviews conducted with 11 HCV primary care
providers and 11 support staff at 3 HIV clinics in Los Angeles,
California. The goals of the study were to explore the factors
and processes by which providers make HCV treatment deci-
sions, and the barriers to HCV treatment uptake, among HCV
treatment-naı
¨
ve HIV patients with chronic HCV infection.
Methods
Study design
We used a process model framework
34
and case study
evaluations with semistructured interviews to explore the
HCV treatment decision making of providers. This approach
assumes that decisions involve considerable uncertainty, as
providers may be uncertain about how to define the deci-
sional problem, the outcomes of decisional options and their
probabilities, or alternative decisional choices. We would ex-
pect providers to deal with this uncertainty by attempting to
simplify the process by emphasizing some aspects of the
problem more than others, to differ in which factors influence
their decisions, and to use heuristics and guidelines to struc-
ture the decision making process. The interviews explored
factors that influence the provider’s decision to recommend or
defer HCV treatment for HIV coinfected patients.
Setting
The study was conducted at three HIV clinics in Los An-
geles, California. As listed in Table 1, the sites differ on a
number of characteristics including the number of HIV pa-
tients and HIV=HCV co-infected patients, involvement of a
liver specialist, and HCV treatment rates.
Each of the sites instituted efforts to increase access to HCV
treatment approximately 5 years ago. Although sites A and B
reside within a hospital or larger medical center, the HIV
coinfected patients at each of the three sites receive their HCV
care at the HIV clinic. Providers from outside the HIV clinic
are involved in HCV care only at site B, where a liver specialist
attends clinic to provide HCV treatment; this is the only site
where a liver specialist is involved.
The system of providing HCV care varies at each of the
three sites. At site A, HIV and HCV primary care are largely
provided by nurse practitioners (NPs) who are supervised by
two infectious diseases (ID) attending physicians. The phy-
sicians often play an active role in consultations with patients,
and treatment decisions are made jointly between the phy-
sicians and the NPs. Support staff includes nurses, case
managers, and mental health providers (psychiatrist and
psychology fellows). This site differs from the other two sites
in two key ways: it does not serve as a repository of referrals
for HCV care from other clinics; and its HCV specific clinic
session is only for patients who are on HCV treatment, not
patients being evaluated for treatment candidacy.
Site B is one clinic located within a hospital that is part of a
larger system of care centers. This clinic provides HCV care to
its patients as well as HIV coinfected patients referred from
one other Los Angeles clinic within the associated care sys-
tem. HIV primary care is provided by four ID physicians at
this site. These physicians refer their HCV coinfected patients
716 WAGNER ET AL.
to one of the hospital’s gastroenterologists who comes to the
clinic to conduct a biweekly HCV care clinic session for HIV
coinfected patients. Some of the physicians refer only patients
whom they believe are good treatment candidates, while
others refer all their coinfected patients for an evaluation. The
gastroenterologist conducts this clinic session in tandem with
one of the clinic’s physician’s assistants (PA); these two pro-
viders evaluate patients and make treatment decisions jointly,
with added consultation from the ID physicians when war-
ranted. Once a patient starts HCV treatment, they are fol-
lowed biweekly by the PA to monitor progress and side
effects, and more intermittently by the gastroenterologist.
Support staff at the clinic includes other PAs and a psychia-
trist.
Site C is part of a large system of HIV clinics operated in Los
Angeles County by a single private organization. This site is
the base of HCV care for all of the organization’s other clinics
in the county; hence, these other clinics refer their HCV co-
infected patients to site C for HCV evaluation and treatment.
The clinic director reports that most of the referring providers
refer all of their HCV patients for evaluation at the time that
HCV is detected; however, some providers do not refer until
they perceive the patient to have some indications for HCV
treatment. The clinic has three primary care providers, of
whom two (one ID physician and one NP) provide HCV
primary care during a once-a-week clinic session devoted
specifically to manage HCV. Support staff includes a phar-
macist who regularly meets with patients on treatment to
monitor side effects, nurses, case managers, and a social
worker who provides mental health counseling; patients with
serious mental illness are referred out for psychiatric consul-
tation and treatment.
Sample
In the summer of 2008, we conducted semistructured in-
terviews with primary care providers, nurses, mental health
providers, case managers, and clinic administrators at each
site. Although primary care providers are likely the primary
decision-makers with regard to whether or not HCV treat-
ment is recommended to patients, we chose to interview these
added stakeholders as well, as they observe and play a role in
the environment in which key decisions occur. At each site,
we attempted to interview all of the primary care providers,
up to two of each type of support staff (e.g., nurse, case
manager, mental health provider), and the clinic administra-
tor (although at each of the sites, the clinic director or ad-
ministrator was also a primary care provider). A total of 22
interviews were conducted. Nine providers and support staff
were interviewed at site A (4 primary care providers, 2 nurses,
2 case managers, and 1 mental health post-doctoral fellow),
7 at site B (5 primary care providers and 2 PAs), and 7 were
interviewed at site C (2 primary care providers, 2 nurses,
2 case managers, and 1 social worker). Among the 11 primary
care providers, the length of experience in HIV coinfected
patients with PEG-IFN=RBV ranged from 3 to 5 years, and
having provided HCV treatment to a range of 2 to 200 HIV
coinfected patients.
Semistructured interviews
The interviews were organized into the following sections:
background information on training and experience provid-
ing HCV care; personal attitudes with regard to liver biopsies
and HCV treatment; clinic procedures=protocols for deter-
mining liver disease stage and providing treatment with PEG-
IFN=RBV; factors influencing HCV treatment decisions; and
perceptions of patient decision making and adherence to HCV
treatment. The primary goal was to understand the factors
that influence provider decisions to recommend or defer HCV
treatment. We examined (1) who makes the decision and
whether multiple providers are involved in the decision-
making process, (2) what physical, mental, behavioral, and
sociodemographic characteristics of patients are considered,
(3) the role of support staff such as nurses, case managers, and
mental health providers in treatment decisions, and (4) whe-
ther organizational policies and=or barriers affect decision
making.
Structured interview guides were constructed to ensure that
all key questions were asked and to permit provider compar-
isons within and across clinics. Open-ended questions pre-
ceded closed-ended questions to avoid biasing responses, to
elicit unanticipated leads for further exploration, and to high-
light areas of greatest significance to the respondents. Standard
probes, such as verification and compare and contrast ques-
tions, were used to more fully elucidate specific content areas.
All interviews were conducted by Drs. Wagner and Chan-
Osilla, digital recorded, and transcribed verbatim. Written in-
formed consent was obtained from all respondents, and all
were remunerated $50 for the interview, except at one site
where institutional regulations did not allow any payment.
Qualitative data analysis
Transcripts were reviewed to identify key themes, as we
looked for text that involved processes, actions, assumptions,
Table 1. Site Characteristics
Site A Site B Site C
Number of HIV patients 1000 400 1700
Patients: % female 25% 5% 15%
Patients: % ethnic=racial minority 85% 72% 75%
Number (%) HIV=HCV coinfected patients 150 100
a
650
a
Number of HCV-treated coinfected patients 15 (10%) 30 (30%) 250 (38%)
Liver specialist involved in HCV care No Yes No
Number of HCV primary care providers 5 6 2
a
Includes HIV co-infected patients referred from other clinics.
HCV, hepatitis C virus.
PROVIDER HCV TREATMENT DECISION-MAKING 717
and consequences, repetitions across informants, and shifts in
content with regard to the decision making process. After
separately examining portions of the transcripts, we reached
consensus about which themes to examine in detail. We
constructed a framework of major factors and components
influencing decision making, and developed a codebook
using standard procedures and text management software
(e.g., Atlas=ti) to mark instances where each theme occurred
in the interviews. For each theme, we examined the range,
central tendency, and distribution, which allowed us to
discover decision criteria, patterns and generalities related to
the decision-making process within and across provider
groups.
Results
HCV treatment protocol and procedures
Each respondent was asked to describe the procedures or
protocol used at the clinic to treat coinfected patients with
PEG-IFN=RBV. At all three clinics, standard doses of PEG-
IFN are used (mostly peginterferon alfa-2a with a dose of
180 mg per week), along with weight-based doses of RBV
(doses ranging from 800 to 1400 mg=d). There was a consen-
sus among all providers that maintaining high, maximum
doses of both PEG-IFN and RBV were important for virologic
response; accordingly, aggressive side effect management
with common use of erythropoietin and recombinant granu-
locyte colony-stimulating factor (G-CSF) to manage anemia
and neutropenia, respectively, were reported at each site.
Occasional use of prophylactic antidepressants for patients
with past histories of depression (not current) was reported by
providers at two sites in an attempt to prevent treatment in-
duced depression.
There was some variation within and across sites with re-
gard to the duration of treatment and rules used for stopping
treatment. For genotype 1 patients, who represent the vast
majority of patients at these clinics, all providers reported a
treatment duration of at least 48 weeks, but providers at two
of the sites reported extending treatment to 72 weeks or lon-
ger. Providers at one site reported extending treatment for
African American patients, given the lower treatment re-
sponse rates found in this subgroup of patients
35
; treatment
was always extended to at least 36 weeks after the point at
which an undetectable HCV viral load was achieved. The
other site reported extending treatment for those on their
second or third course of IFN treatment, and with advanced
disease, risk of liver decompensation, or a fatty liver. For ge-
notype 2 and 3 patients, providers at two sites reported con-
sidering a treatment duration of less than 48 weeks, while the
other site reported maintaining 48 weeks as the treatment
duration. Finally, providers at one site reported that they had
recently started to consider early virologic response (unde-
tectable HCV viral load by Week 4 of treatment) as an indi-
cation for shortening treatment, even among genotype 1
patients, and especially if tolerance of treatment side effects
was a problem for the patient.
Studies consistently show that if a patient does not achieve
virologic response by week 12, there is virtually no chance of
achieving a sustained virologic response,
13,14
which has led
many providers to discontinue treatment at week 12 in the
absence of a 2-log drop in HCV viral load. None of the pro-
viders indicated strict adherence to this criteria for stopping
treatment at week 12, but at each clinic there were providers
who reported using this rule in their decision making. Several
indicated that even if there was not a 2-log drop in viral load,
they would consider continuing treatment if there was some
response. At two of the sites there were providers who pre-
ferred to treat for at least 24 weeks before possibly dis-
continuing treatment.
Factors that influence treatment decision making
The three participating sites reported substantially differ-
ent treatment rates, ranging from 10% at site A to 38% at site C
(Table 1). The lower treatment rate at site A is likely in part
due to the two organizational factors that differentiate it from
sites B and C as described in the site descriptions. With pa-
tients from other clinics referred to sites B and C for HCV care,
it is likely that at least some of these patients are referred
because they are appropriate for HCV treatment, therefore
increasing the proportion of the patient pool that warrants
treatment initiation. Also, at sites B and C the coinfected pa-
tients (regardless of whether they are on HCV treatment or
not) receive care during the HCV subclinic sessions where
providers can focus solely on the patient’s HCV care man-
agement; whereas at site A, patients who are not on HCV
treatment are intermingled among other HIV patients and
HCV is one of many problems that are discussed by the pri-
mary care providers.
These organizational differences not withstanding, pro-
vider approaches to treatment decision-making may also be a
significant contributor to the differences in treatment uptake.
Our interviews with providers and staff at each of the three
sites clearly indicated that this decision process is almost so-
lely in the hands of the primary care providers, and so the
following analysis centers on the interviews with the primary
care providers. The support staff play an informative role in
the decision process, which will be described later. The factors
that influence provider treatment decision making, as eluci-
dated in these interviews, can be broken into three main
components: biologic (HIV and HCV diseases), psychosocial
(motivation, adherence, mental health and substance use),
and provider or organizational.
Biologic factors
When speaking of the process by which decisions are made
regarding the appropriateness of HCV treatment for an in-
dividual patient, providers focused first on biological disease
factors. With this study focusing on HIV coinfected patients,
providers spoke of a dual emphasis on HIV and HCV dis-
eases.
Stability of HIV disease. There is little difference between
the sites with regard to the role of HIV disease in HCV
treatment decisions, as all providers spoke of the need for a
patient’s HIV disease to be stable prior to initiation of HCV
treatment. Considerations in determining stability of HIV
included HIV viral load, CD4 count, HIV antiretroviral regi-
men, and opportunistic infections. Providers at Site B said that
CD4 counts must be above 200, as declared by one provider,
‘I do not make an exception on that rule.’ Providers at the
other two clinics spoke of wanting CD4 count to be in the
300s, although there was not a rigid threshold. All providers
also spoke of a need for very low HIV viral levels, and one
718 WAGNER ET AL.
provider at site C reported that viral load must be undetect-
able if the patient’s CD4 is not in the 300s.
There is no good reason at this time that they should have
detectable (HIV) viral loads. There are fabulous drugs out
there. I probably can count on my fingers, maybe three or four
people who have detectable viral loads at this point. There are
no good reasons for that. That is something I don’t accept. (C1)
For patients with low CD4 (<350), the patient needed to be
on ART for at least several weeks and responding to it well in
terms of tolerance, adherence and clinical response. In addi-
tion, providers spoke of needing to switch antiretrovirals for a
patient whose ART regimen included zidovudine (AZT) or
didanosine (DDI), which have been shown to have interaction
effects with RBV.
21
The patient needs to be stable on the new
regimen with the replacement antiretrovirals prior to ini-
tiating HCV treatment. Finally, all acute HIV opportunistic
infections and other medical conditions (e.g., anemia, neu-
tropenia, hypothyroid) need to be effectively treated and in
remission prior to initiating HCV treatment.
HCV disease stage. Once a patient’s HIV disease is sta-
ble, providers then shift their focus to the patient’s HCV and
liver disease. A series of laboratory tests and procedures are
used to determine the patient’s stage of liver disease and the
appropriateness for HCV treatment. Standard practice at each
of the clinics is an assessment of physical symptoms that may
be suggestive of liver disease and a routine laboratory work-
up that includes HCV viral load, genotype, liver function tests
(LFTs), and a panel of others tests including alpha fetaprotein,
platelet counts, albumin, and others. Although these tests
have a low level of precision in evaluating liver disease stage,
they are able to provide some indications of the presence of
disease progression. If the labs show elevated liver enzymes
or signs of liver inflammation, ultrasounds and computed
tomography (CT) scans were performed to further evaluate
the condition of the liver at each site.
Liver biopsies have been the gold standard for evaluating
stage of liver disease and fibrosis, but have been used very
sparingly at the study sites (ranging from none to five or six
biopsies performed over the past 2 years) unless treatment
was being provided as part of a research study in which bi-
opsies were required. All providers spoke of informing
treatment candidates that they could have a biopsy done, but
that it was not needed for treatment to be provided, and pa-
tients typically opted out of having the procedure. Barriers
such as low insurance rates for covering the cost (site C)
and low institutional capacity for performing the biopsies (site
A) also contributed to the low utilization of the procedure.
Reasons that biopsies were viewed as not being essential in-
cluded the rationale that disease progression is much more
rapid in HIV patients and thus treatment needs to be initiated
earlier, few co-infected patients have no signs of disease, and
the potential inaccuracy of biopsies.
36
Furthermore, at each
site, biopsies were only considered when treatment was a
possible option for the patient; this meant that the patient
was both an appropriate candidate for treatment based on
other criteria, and was at least willing to consider treatment.
This latter condition includes patients who are ‘on the fence’
about treatment and could benefit from seeing evidence
from the biopsy about the state of their liver before making a
decision.
I cannot think of anyone who’s gotten a liver biopsy who was
not interested in treatment. People will say, ‘Well, if I don’t
want treatment, why do I want to subject myself to an invasive
procedure?’ In honesty, it probably comes the other way also.
It’s like if you’re not ready (for treatment), then what are we
going to do with that information (from a biopsy)? What
would we do different (with regard to treatment) with the
information from a liver biopsy? But I have said to patients, ‘If
you knew that you had progressive disease, would that change
your mind about treatment? And, if so, then that liver biopsy
would actually be worthwhile getting.’ But I haven’t had
anybody take me up on that. (A2)
There were noted differences across the sites with regard to
the role of HCV disease stage in determining appropriateness
of HCV treatment initiation. The providers were unanimous
in seeing no need for a biopsy if the patient had a genotype of
2 or 3, as these patients were generally seen as appropriate for
treatment given the high rate of treatment success with these
patients. In contrast, the providers differed considerably in
how they approach genotype 1 and 4 patients. Several pro-
viders at sites A and B spoke of a preference for deferring
treatment if signs of disease were minimal; these providers
perceived LFTs and liver biopsies as being useful for assessing
stage of disease and clarifying the need for treatment.
We’re not necessarily promoting treatment to patients who
have normal LFTs. Not because there’s great data behind that,
but just because it’s a toxic treatment and we don’t always get a
great result; in fact, more often than not we don’t (get a good
treatment response). (A1)
Some patients have a low chance of getting a good result
(treatment response), and if they have no indication of chronic
liver disease, then they are better off waiting, and we wouldn’t
do a biopsy on those. Patients who have an indication that they
may, may have some cirrhosis—some abnormality in ultra-
sound, a liver that feels firm upon examination, any indication
they might have fibrosis—even though they have a minimum
chance or a relatively lower chance of getting a good response,
those patients can benefit significantly, depending on their
stage from a biopsy. They can benefit significantly from giving
the interferon and ribavirin a shot. So those patients we would
biopsy to determine stage of disease. (B3)
Conversely, providers at site C and some at site B view all
patients as treatment candidates with regard to liver disease
stage as long as the liver is not decompensated. (Decom-
pensated liver was a contraindication to treatment for pro-
viders at all three clinics).
I really look at it very much from an infectious disease per-
spective. It’s an organism in the body that doesn’t belong there;
it needs to get out of the body. If somebody is a candidate, has a
good ability to do treatment, I will go ahead and treat, because
I don’t want them to be sicker and then treat them later on.
That’s because it’s two issues. It’s the HIV and the Hep C. We
know that HIV progresses faster; we know that Hep C pro-
gresses faster. Both of these are having a negative effect on each
other. There is no reason to not treat them. (C1)
Providers at Site C put little credence into the value of LFTs
and biopsies. Although one provider added the caveat that if
more effective and less toxic treatments were available, dis-
ease stage would be more relevant and biopsies may be
viewed as more important. Also, site C often uses the Fi-
brosure test (profile of biochemical markers) to elicit infor-
mation about disease progression and fibrosis.
PROVIDER HCV TREATMENT DECISION-MAKING 719
Psychosocial factors
Once it is determined that the patient’s HIV disease is stable
and their liver disease stage is appropriate for treatment, then
the provider’s focus shifts to the patient’s psychosocial read-
iness for treatment. Specifically, each provider spoke of the
importance of the patient’s motivation and commitment to
undergo treatment, and demonstration of being ready to ad-
here well. Mental health and substance abuse were also con-
sidered by all providers, but with different conditions for
being appropriate for treatment.
Motivation. While the biologic appropriateness of the
patient may be the first thing that a provider assesses, if the
patient is not interested in starting treatment, then treatment
is not even a possibility. Providers spoke of the need for pa-
tients to understand the importance of treatment for their
long-term health, and to be willing and motivated to adjust
their lifestyle if necessary. Only a few providers spoke of
trying to persuade resistant or ambivalent patients about
the importance of treatment and these providers tended to be
those who reported higher treatment rates and a greater sense
of urgency towards treatment initiation. One provider at site
C was particularly outspoken about her philosophy of trying
to treat every patient and to treat as soon as the patient is
willing. This provider spends considerable time educating the
patient and emphasizing the importance of treatment until it
starts to sink in.
I tell them, ‘A year and we’re talking (viral) eradication. This is
a very important concept and so I really want you to under-
stand. I’m not talking of lifelong therapy. I’m trying to shoot
for eradication. We’re getting it out of the body. So whatever it
takes.’ (C1)
Adherence. All providers spoke of the patient being
ready to adhere well to treatment as a critical factor in de-
termining whether treatment would be recommended. Most
providers used clinic attendance, and adherence to ART (if
applicable) as key indicators of whether the patient was ready
to adhere to PEG-IFN=RBV.
Generally substance abuse, nonadherence with clinic, signs of
nonsdherence with other medications, like HIV medications or
other medications, then we would feel that they might not be
ready for treatment. If we feel that they will be able to adhere,
and they’re willing to try to go through the side effects-not
everybody gets the side effects-then we feel that they will be
able to do well with treatment. (A3)
They need to come frequently. If they can’t, then that is another
thing I guess that I always look at too, is if they can’t make
frequent visits, then I don’t think I would start therapy, be-
cause they wouldn’t be monitored adequately. I tell them right
up front. (C2)
Mental health. Providers at each clinic reported some
level of screening of depression and psychiatric problems, and
needing clearance from mental health providers before start-
ing a patient on HCV treatment. However, there was varia-
tion in the definition of who was required to have such a
clearance. At the site with the lowest treatment uptake (site
A), one provider said that all patients who are potential
treatment candidates are required to have a mental health
screening and clearance, while another provider at that clinic
indicated that such a clearance was needed if the patient had
current psychiatric problems. At Site B, patients with any
history of depression or mental illness, past or current, were
required to have a mental health clearance. Finally, the site
with the highest treatment uptake (site C) required a mental
health consultation and clearance only for patients with cur-
rent serious psychiatric problems such as suicidality or severe
depression, schizophrenia, and bipolar depression.
Patients with current mental health problems were re-
quired not only to be cleared for HCV treatment by a mental
health provider, but also had to receive mental health treat-
ment for the problem such that the condition was stable or in
remission, and to receive ongoing follow-up and monitoring
from the mental health provider. An exception to this was at
Site C where the lead provider views moderate depression as
less problematic, and the decision of whether to postpone
HCV treatment until the depression is treated is left up to the
patient after a thorough discussion about the options and
risks.
Depression is so common; it’s in 60% of the patients. Depres-
sion is not something that’s going to stop me treating them. I
just need to know how they understand their depression. I will
analyze what they think, what they understand, how they
know that this is going to make their depression worse. If
they are depressed, I will ask them, ‘Do you need an anti-
depressant? Do you think that this will get worse?’ The other
thing I think is that they’re in control; I’m not. I ask them to
decide everything. ‘Do you think that your depression is at a
point where, if it gets worse, will you be able to handle it?
Because it takes three weeks or whatever for it to be effective,
do you want me to start now or do you want to start later? Do
you want to tell me when?’ They’re very involved in that de-
cision. (C1)
Substance use. Each provider reported some criteria
related to substance use, but as with mental health, providers
at the clinics with higher treatment rates described greater
leniency regarding reports of some substance use, and there
were differences with regard to alcohol versus illicit drug use.
At Sites A and B, some providers said absolutely no drinking
or use of drugs was allowed for as long as 6 months before
treatment could be initiated.
With me it’s a hard and fast rule (no drugs and alcohol for
6 months). I tell them, ‘If I test you (urine sample) and I find its
positive, then I’m going to recommend that you stop treat-
ment. (B5)
So what I tell the patients is this, especially with alcohol, where
there’s evidence for this: I say that the alcohol can make the
virus proliferate faster and makes the disease progress faster,
and it’s only adding one other factor to make the disease
worse, and patients who drink are not going to respond to the
drugs, and that’s actually established. So I say, ‘You can’t
drink, and you’ve got to be committed to that, and one way to
be committed is not to drink for six months. And then I’m
confident that you’re committed.’ And so I say, ‘You know, I
just don’t feel you’re ready for that. You’re not going to be able
to follow through. It’s kind of complicated, and you’re not
there yet.’ And they actually agree with me. They’ll say, ‘Yeah,
doc, give me 6 months, I’ll get myself in shape.’ (B2)
Yet even the provider quoted above said that if a patient
told him that he had an ‘occasional’ drink, he would treat the
patient as long as the patient did not have a history of alco-
720 WAGNER ET AL.
holism. At each site there were providers who said they en-
couraged patients not to drink and use drugs but would still
provide treatment if the patient only had a few social drinks or
used some marijuana. A number of providers singled out
marijuana as an exception, and would allow it to be used, but
not other types of drugs. Some providers at each of the sites
referred to substance use as a gray area in determining a pa-
tient’s readiness for treatment and they made these decisions
on an individual case basis.
In regards to alcohol and substance use, my own perspective is
that we don’t want to be punitive. A person who has a glass of
beer a week is a person that could still be treated. The person
who is engaging in the sporadic marijuana for appetite is dif-
ferent than the person who’s using crack cocaine under bridges
and alleys, so to speak. But most of these factors, you know,
there’s a little bit of a gray scale here rather than absolute black
and white situation, and clearly judgment is applied. (B1)
While providers at sites A and B did not allow active illicit
drug use (other than marijuana), at site C the providers were
willing to provide HCV treatment to patients who were ac-
tively using drugs such as cocaine and crystal methamphet-
amine, so long as they believed the patient was sufficiently
motivated and adherent. This viewpoint was influenced by
observations of patients who regularly used drugs, yet were
still able to adhere well to ART.
I have had very good success. I have a couple or maybe one
person who uses cocaine, maybe one or two other people who
use something else. I think it’s Ecstasy or something like that.
But most of them are crystal meth users. And they can be very
compliant. I have this patient who uses crystal meth regularly
every week, but he is fabulous with taking his HIV meds. (C1)
I think if they’re actually able-if they’re interested enough to be
there, and they understand the treatment is 48 weeks, and
they’re willing to start it knowing the side effects and every-
thing, even if they are using, I would not deny them treatment.
(C2)
One of these providers at site C spoke of an emphasis on
being nonjudgmental with patients about their substance use
and that this enables patients to be candid about their use.
This in turn results in mutual trust and respect and often the
patient taking on a sense of responsibility in terms of their
treatment behavior and assessing the impact of their drug use.
I’m very nonjudgmental and very clear about this. ‘Are you
taking them now? I need to know this.’ They’re very honest.
They’re very open. I have had them say it very nicely, ‘I want
to tell you that I’m going to be doing crystal for these three
days. So whatever regimen we have to do, we have to make it
work around this so it doesn’t coincide with my crystal tak-
ing.’ (C1)
The one person that I’m planning to treat now, he’s down to
one can of beer a week. I have to trust him. That’s what he
tells me. I talk a lot about this. ‘I need to trust what you’re
telling me because everything that I design, everything that I
do will be based on what you tell me. If I can trust you, I can
make sure that I can fix things for you. If I can’t trust you,
there’s no point in you doing this.’ (C1)
Provider characteristics
As providers consider a patient’s HIV and HCV disease
factors, and psychosocial readiness for treatment, this delib-
eration and decision making process is influenced by the
provider’s overall view of HCV treatment and in particular
the degree of urgency needed in initiating treatment. Among
the providers in this study, those at site C have the most
urgent view of treatment, and they spoke emphatically of the
sense of obligation to treat all patients as soon as a minimal
level of criteria was achieved.
I did general ID in the hospital and the reason I got into this
was because I saw so many people dying of Hep C-not HIV but
Hep C. I didn’t know anything about Hep C at that time. I
started referring them out and I had the most difficult experi-
ence with people that I referred out. They would come back
three months later, huffing and puffing. I think I even told you
about this guy too, white as a ghost, hemoglobin of 5. You can’t
see these patients three months later. That’s not possible in co-
infected patients. That’s when I thought, ‘Okay, I need to do
this. Because this is a 32-year-old guy who should not be dead,
who should not be dying.’ That’s the background in the way I
approach it now. I do not want to be the judge of whether I will
offer you treatment. I’m not God. So I don’t want to play that I
will offer you treatment, I will not offer you treatment. The
philosophy I have is that I offer everyone treatment, because
that’s their right. (C1)
Another provider, at site B, who advocates for aggressive,
urgent care, spoke of how his clinic has evolved over the
5 years of its existence, and that through their experience in
treating patients that many thought were ‘risky’’, and ob-
serving the success of treatment, that the clinic providers have
grown in confidence and willingness to treat more aggres-
sively.
If we went back several years ago I would’ve been pushing
my GI doc to treat where he did not necessarily want to
treat. Whereas my colleagues were more wary of treating a co-
infected individual. Now that we’ve been doing this for the
four or five years and we have accrued the surprising treat-
ment successes, that I think my colleagues have come to be
more comfortable with treating individuals and are sharing
my perspective that people warrant therapy. And our GI col-
league is, as well, more comfortable treating patients who he
would have regarded as poor treatment candidates a few years
ago. So there’s been really a shift in opinion. (B1)
In contrast, there were providers at sites A and B who took
a more cautious view of treatment. These providers viewed
treatment as urgent for some patients with advanced disease,
but for many patients with less progressed disease they be-
lieved it was best to defer treatment. The perspective of these
providers puts greater weight on the burden of toxicity and
limited success rate of treatment, and the ability to monitor
disease and wait for better treatments to become available.
From my point of view, it’s seldom an emergency decision on
these patients to treat or not. And I think the fact is, the trials
are looking really great—the protease inhibitors that are
coming out, the anti-hep C drugs. I’m not saying don’t treat the
patient, but do you have to jump in now with that patient? Or is
this patient sufficiently low risk that you could monitor and
maybe wait for the next round of studies in the next 12–24
months before making that decision and having the patient go
through the interferon ribavirin routine? I might feel inclined
to say, ‘Look, if you’re anxious to be treated, let’s do it, okay.
We will know by week 12 whether you’re likely to benefit from
going on or not. So we could do that. On the other hand, we are
reasonably certain, based on our tests, including a biopsy, that
you don’t have any significant fibrosis at this point, so that if
you chose to, we think at maximum 4 or 5 years, there will be a
PROVIDER HCV TREATMENT DECISION-MAKING 721
very good or maybe a couple of good agents around that we
would combine with interferon, plus or minus ribavirin. So
you may want to have us watch and wait and talk about it for
the next year or so.’ (B3)
I tell them, ‘You have HCV. This is long-term, it’s not an
emergency, but we’d like to discuss treatment with you.’
When we tell them about the treatment, the injectable nature of
it and the side effect profile—it makes them not want to discuss
it further. If biopsies were more of an option, we could avoid
treating people with earlier stage liver disease, who can afford
to wait for better, less toxic treatment to become available,
instead of undergoing treatment now and suffering through it
when it might not work, probably wont work. (A1)
Role of support staff providers
Support staff providers, such as nurses, mental health
providers (social workers, psychiatrists, psychologists), and
case workers also have a role in the HCV treatment decision
making of primary care providers. Primary care providers
typically have 10–15 minutes to spend with patients during
regular clinic visits, whereas support staff can often spend
quite a bit more time. This affords them the ability to develop
a rapport with the patient, to hear about social and behavioral
aspects of the patient’s life that are troubling the patient, to
provide education and support to the patient, and address
issues such as side effects and adherence problems. A number
of the support staff described how primary care providers
seek their information and opinions about the patient’s
readiness for treatment with regard to mental health status,
substance use, and ability to adhere. Hence, the opinions of
the support staff can contribute to the decision of the primary
care provider to either recommend or defer treatment.
I think we play the role of basically providing the clinical staff
with the current mental status of the client, the client’s be-
havioral focus, the client’s interest in treatment, and giving
background as to whether or not the client would be interested
in treatment. (A8)
They ask (our opinion). And most of the time we agree. We say,
‘He’s not ready for that. We have to first take care of this, this,
and that before you can consider starting him on treatment.’
Once we have him in this place stable, then we could go back
and address the treatment. Whatever issue it is that the patient
needs to be worked on, and if I can help them, then I work with
the patient. (A4)
I’m a middle person. Sometimes they’re not that open with the
nurse practitioner. Maybe that patient is drinking and he’s not
telling her. But he might tell me. And then maybe she’s
thinking he’s ready for treatment. But then I’ll go back and say,
‘You know what? He’s not ready. They (the patients) are
definitely more up to talking with me. I get that a lot of times. ‘I
didn’t tell my doctor, but I just wanted to say that I’m using
again.’ ‘Why didn’t you tell your doctor?’ ‘I didn’t want them
to be angry with me.’ (A4)
Discussion
HCV treatment rates reported by providers at the three
participating sites ranged from 10%, which is similar to those
found in the literature,
6–12
to as high as 38%. With providers
being the primary gatekeepers of treatment access, we sought
to examine how the decision making process differs across the
primary care providers at these three sites.
Stable HIV disease is clearly a basic tenet to HCV treatment
being considered. Providers at each of the three sites preferred
CD4 counts to be in the 300s and certainly greater than 200
before treatment could be considered. This is consistent with
published HCV treatment guidelines for HIV patients,
21
and
evidence that HCV treatment is more successful with higher
CD4 counts,
25
and that HCV treatment depletes CD4 cells
during the course of treatment, rendering patients vulnerable
to opportunistic infections.
37
With a stable HIV disease, pro-
viders then shift their focus to the patient’s HCV and stage of
liver disease. All providers agreed that late stage, decom-
pensated liver disease was a treatment contraindication due
to the risk of serious side effects, and that the few patients with
genotype 2 or 3 should be treated when at all possible given
the high treatment response rates in these patients. Further-
more, there was general consensus that genotype 1 and 4
patients with significant signs of disease, fribrosis and liver
inflammation should be treated.
Where these clinics and providers differed was in the
treatment of genotype 1 and 4 patients who have no or min-
imal signs of liver disease. At sites with lower treatment rates,
providers preferred to delay treatment for these patients, cit-
ing low treatment response rates, high toxicity burden, and
better treatment options on the horizon, thus weighing the
costs of treatment to be greater than the likely benefits. Pro-
viders at Site C (and some at Site B), who reported higher
treatment rates, viewed all patients as needing treatment as
soon as possible regardless of whether or not there were signs
of disease; these providers cited the added risk for rapid
disease progression associated with HIV,
38
the greater likeli-
hood of treatment success with milder disease,
39
the chance of
a cure, and the confidence to help patients successfully man-
age side effects. Provider attitudes toward liver biopsies were
influenced by this decision process as providers who pre-
ferred to treat these patients saw little or no value in having a
biopsy done, whereas providers who would rather defer
treatment viewed biopsies as being able to confirm the stage
of liver disease and treatment decision. Yet regardless of these
attitudes, biopsies are not needed to provide treatment at
these sites and each site reported that very few biopsies had
been performed on their patients.
Given the low uptake of treatment reported in the litera-
ture,
6–12
and studies that report mild liver disease to be a
common reason for treatment ineligibility,
28,40
it appears that
most providers in the field side with those who favor the
‘wait and monitor’ approach for genotype 1 and 4 patients
with mild disease. This approach aims to spare the patient
from having to endure a toxic treatment that for most will
provide no virologic benefit, so long as the patient’s liver
disease does not progress significantly. Providers must bal-
ance waiting for indicators of significant liver disease pro-
gression with the risk of waiting too long such that treatment
is likely to be less successful or even contraindicated because
the liver disease is too advanced or because CD4 count drops
too low, both of which are common reasons for coinfected
patients being excluded from HCV treatment.
7
Whether a
patient is treated early in the disease stage, or not until there
are at least moderate signs of disease progression, would
not have significant policy implications if treatment was in
fact eventually started. But the low treatment rates reported in
the literature, and data showing that most coinfected pa-
tients have at least moderate signs of fibrosis,
4,5
highlight the
role that nondisease factors play in treatment decision
making.
722 WAGNER ET AL.
Regardless of whether providers prefer to treat early or
delay treatment depending on disease stage, they must still
assess the patient’s psychosocial readiness for treatment. All
providers agreed on the key components of readiness, those
being patient motivation and interest in treatment, demon-
stration of ability to adhere to treatment and clinic appoint-
ments, and a mental health status that will not impede ability
to adhere and tolerate treatment. These readiness components
account for a large proportion of the patients not being trea-
ted.
6–12
However, while there was general agreement on the
components of readiness, there was considerable variation in
how providers viewed the influence of depression and
substance use in determining a patient’s readiness for treat-
ment.
Mental illness and substance use are leading causes for
treatment deferment,
6–8,27,28
and thus are prime reasons why
many patients with significant liver disease continue to be
untreated. Yet the empirical evidence is mixed with regard to
the effects of these conditions. A number of studies have
found that HCV treatment response and completion rates do
not differ between patients with or without histories of psy-
chiatric illness or substance abuse, nor between active drug
users and nonusers.
29–31,41,42
However, other studies have
found that patients with past psychiatric problems are more
likely to need psychiatric care during HCV treatment
43
and
that patients who are depressed at treatment baseline are less
likely to respond to treatment.
44
While all providers in the
study called on mental health screens and clearance for some
patients, and required that serious mental illness be stabilized
by psychiatric treatment prior to initiating HCV treatment,
the views on depression varied. Most providers spoke of the
need to use antidepressants to stabilize current depression
before starting HCV treatment, and some used antidepres-
sants as a prophylactic for patients with past depression.
However, the provider who reported the highest treatment
uptake had the most lenient approach, indicating that un-
treated moderate depression would not prevent prescription
of HCV treatment, and that it was up to the patient to decide
whether or not they wanted depression treatment prior to
starting HCV therapy once they were informed of the possible
options and risks of not treating the depression.
There was even more variation in how the providers
viewed current use of alcohol and illicit drugs. A few pro-
viders spoke of no tolerance for any alcohol and drug use for 6
months prior to the patient being considered ready for treat-
ment, which is a common standard in the field.
45
But several
experts and patient advocates have called for a more flexible
approach—one that looks at the individual circumstances for
each patient.
29,46
All providers in the study spoke of strongly
encouraging their patients to abstain from use of alcohol and
drugs, but several conceded that there was a ‘gray zone’ in
judging this criteria and that they would allow an occasional
drink or use of marijuana, but not harder drugs. Similar to
evaluations of mental health, the providers at the site with
the highest treatment rate were most willing to offer treat-
ment to patients who were actively using drugs such as
crystal methamphetamine, so long as the patient convinced
them that they could still adhere to treatment.
In conclusion, findings from this study highlight two ap-
proaches to managing HCV treatment decisions. One views
treatment initiation as more urgent and is willing to accept the
risk of a more lenient definition of patient readiness for
treatment. The other takes a more cautious approach with a
preference for holding off treatment until it is clear that a
patient’s liver disease is in need of treatment and the patient
has all the signs of being ready to adhere well. There is no clear
evidence indicating whether one approach is more appro-
priate than the other. An urgent approach to treatment results
in more patients being treated and thus more patients being
‘cured,’ but also more patients who endure significant side
effects that compromise mental health and quality of life
without virologic benefit.
Conversely, delaying treatment can reduce unnecessary
burden on a patient’s quality of life, and better, less toxic
treatment may become available before the patient’s disease
progresses to the point of definitively needing treatment;
however, ultimately treatment is needed to avoid liver failure
and the longer a patient waits, the lower the odds of treat-
ment being successful with the currently available treatment.
Regardless of which approach may be more appropriate,
development of effective programs for promoting patient
readiness for treatment are critical to ensuring that more pa-
tients receive treatment, either earlier in the disease or later,
given the high mortality associated with liver disease among
HIV=HCV coinfected patients.
Finally, the examination of treatment uptake rates and the
treatment decision making process cannot be fully under-
stood without accounting for the role of the patient and their
decision process for requesting, accepting or refusing treat-
ment. Provider decisions to recommend or offer treatment is
critical to providing treatment access, but whether or not a
patient starts treatment is ultimately in the hands of the pa-
tient. Studies show that 10%–20% of HIV coinfected patients
choose to refuse HCV treatment.
47
In addition to analyzing
the qualitative interviews of coinfected patients who partici-
pated in this study, we will soon conduct a quantitative sur-
vey of HCV providers and their HIV coinfected patients. The
goal of these assessments is to better understand the multi-
level factors that contribute to the treatment decision making
of both providers and patients, and to inform the develop-
ment of intervention strategies for improving HCV treatment
uptake and outcomes for HIV coinfected patients.
Acknowledgments
This research is supported by National Institutes of Health
grant R21 MH078740 (PI: G. Wagner).
Author Disclosure Statement
No competing financial interests exist.
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Address correspondence to:
Glenn Wagner, Ph.D.
RAND Corporation
1776 Main Street
Santa Monica, CA 90407
E-mail: gwagner@rand.org
PROVIDER HCV TREATMENT DECISION-MAKING 725
    • "Despite recent and emerging advances in treatment, barriers to care persist, particularly for HCV care. The most common barriers are at the systems level (e.g., limited infrastructure for assessment and treatment, accessing care, high treatment costs), provider level (e.g., perceptions of poor patient adherence, concerns for active drug abusers, lack of experience treating patients), and at the patient level (e.g., lack of knowledge, misconceptions, level of motivation) [20,34]. Potential strategies to improve engagement in care include routine HCV testing and linking patients to care immediately following diagnosis. "
    [Show abstract] [Hide abstract] ABSTRACT: Few studies have explored how utilization of outpatient services differ for HIV/HCV coinfected patients compared to HIV or HCV monoinfected patients. The objectives of this study were to (1) compare annual outpatient clinic visit rates between coinfected and monoinfected patients, (2) to compare utilization of HIV and HCV therapies between coinfected and monoinfected patients, and (3) to identify factors associated with therapy utilization. Data were from the 2005-2010 U.S. National Hospital Ambulatory Medical Care Surveys. Clinic visits with a primary or secondary ICD-9-CM codes for HIV or HCV were included. Coinfection included visits with codes for both HIV and HCV. Monoinfection only included codes for HIV or HCV, exclusively. Patients <15 years of age at time of visit were excluded. Predictors of HIV and HCV therapy were determined by logistic regressions. Visits were computed using survey weights. 3,021 visits (11,352,000 weighted visits) met study criteria for patients with HIV/HCV (8%), HIV (70%), or HCV (22%). The HCV subgroup was older in age and had the highest proportion of females and whites as compared to the HIV/HCV and HIV subgroups. Comorbidities varied significantly across the three subgroups (HIV/HCV, HIV, HCV): current tobacco use (40%, 27%, 30%), depression (32%, 23%, 24%), diabetes (9%, 10%, 17%), and chronic renal failure (<1%, 3%, 5%), (p < 0.001 for all variables). Annual visit rates were highest in those with HIV, followed by HIV/HCV, but consistently lower in those with HCV. HIV therapy utilization increased for both HIV/HCV and HIV subgroups. HCV therapy utilization remained low for both HIV/HCV and HCV subgroups for all years. Coinfection was an independent predictor of HIV therapy, but not of HCV therapy. There is a critical need for system-level interventions that reduce barriers to outpatient care and improve uptake of HCV therapy for patients with HIV/HCV coinfection.
    Full-text · Article · Apr 2014
    • "HCV treatment decisions for PWID with coinfection have added complexity because of issues related to the timing of antiretroviral therapy (ART), the severity of HIV disease, and drug-drug interactions [4]. Qualitative research with primary care HIV providers in the United States found that experienced providers agree that stable HIV disease, favorable HCV genotype, and advanced liver disease are all factors supporting a stronger recommendation for HCV treatment [18]. However, many providers are deferring therapy, given that IFN-sparing regimens with increased simplicity (once-daily dosing and shorter therapy duration), improved tolerability and efficacy will probably soon be available. "
    [Show abstract] [Hide abstract] ABSTRACT: The majority of hepatitis C virus (HCV) and human immunodeficiency virus (HIV) coinfection occurs among persons who inject drugs. Rapid improvements in responses to HCV therapy have been observed, but liver-related morbidity rates remain high, given notoriously low uptake of HCV treatment. Advances in HCV therapy will have a limited impact on the burden of HCV-related disease at the population-level unless barriers to HCV education, screening, evaluation, and treatment are addressed and treatment uptake increases. This review will outline barriers to HCV care in HCV/HIV coinfection, with a particular emphasis on persons who inject drugs, proposing strategies to enhance HCV treatment uptake and outcomes.
    Full-text · Article · Mar 2013
    • "A few provider surveys have revealed reasons for classifying patients as ineligible for IRT (Fultz et al., 2003; Thompson et al., 2005). However, there is a lack of data on how providers' treatment decisions are shaped by their assessment of IRT's side effects against its effectiveness (see exception, Wagner et al., 2009). "
    [Show abstract] [Hide abstract] ABSTRACT: Despite the high prevalence of hepatitis C virus (HCV) infection among injection drug users also infected with human immunodeficiency virus (HIV), and the synergistic adverse effect of the two diseases on patients' health and survival, research on the clinical management of these patients and particularly the low uptake of HCV therapy is limited. We conducted qualitative interviews with 17 HIV providers from two urban public hospitals. We discovered that the limitations of the current state of medical knowledge, the severe side effects of HIV and HCV therapies, and the psychosocial vulnerability of HIV/HCV-coinfected patients combined with their resistance to becoming informed about HCV posed significant challenges for providers. To contend with these challenges, providers incorporated key dimensions of patient-centered medicine in their practice, such as considering their patients' psychosocial profiles and the meaning patients assign to being coinfected, and finding ways to engage their patients in a therapeutic alliance.
    Article · Aug 2011
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