Can J Gastroenterol Vol 22 No 4 April 2008376
Evaluation of oral cannabinoid-containing
medications for the management of interferon and
ribavirin-induced anorexia, nausea and weight loss in
patients treated for chronic hepatitis C virus
Cecilia T Costiniuk MD1, Edward Mills PhD2, Curtis L Cooper MD FRCPC3
1Department of Internal Medicine, University of Ottawa, Ottawa, Ontario; 2British Columbia Centre of Excellence in HIV/AIDS, University of
British Columbia, Vancouver, British Columbia; 3University of Ottawa, Division of Infectious Diseases, The Ottawa Hospital – General
Campus, Ottawa Health Research Institute, Ottawa, Ontario
Correspondence: Dr Curtis L Cooper, Room G12-501 Smyth Road, The Ottawa Hospital – General Campus, Ottawa, Ontario K1H 8L6.
Telephone 613-737-8924, fax 613-737-8164, e-mail firstname.lastname@example.org
Received for publication October 10, 2007. Accepted November 29, 2007
CT Costiniuk, E Mills, CL Cooper. Evaluation of oral
cannabinoid-containing medications for the management of
interferon and ribavirin-induced anorexia, nausea and weight
loss in patients treated for chronic hepatitis C virus. Can J
OBJECTIVES: The systemic and cognitive side effects of
hepatitis C virus (HCV) therapy may be incapacitating, necessitating
dose reductions or abandonment of therapy. Oral cannabinoid-
containing medications (OCs) ameliorate chemotherapy-induced
nausea and vomiting, as well as AIDS wasting syndrome. The efficacy
of OCs in managing HCV treatment-related side effects is unknown.
METHODS: All patients who initiated interferon-ribavirin therapy
at The Ottawa Hospital Viral Hepatitis Clinic (Ottawa, Ontario)
between August 2003 and January 2007 were identified using a com-
puterized clinical database. The baseline characteristics of OC recip-
ients were compared with those of nonrecipients. The
treatment-related side effect response to OC was assessed by χ2analy-
sis. The key therapeutic outcomes related to weight, interferon dose
reduction and treatment outcomes were assessed by Student’s t test
RESULTS: Twenty-five of 191 patients (13%) initiated OC use.
Recipients had similar characteristics to nonrecipients, aside from
prior marijuana smoking history (24% versus 10%, respectively;
P=0.04). The median time to OC initiation was seven weeks. The
most common indications for initiation of OC were anorexia (72%)
and nausea (32%). Sixty-four per cent of all patients who received
OC experienced subjective improvement in symptoms. The median
weight loss before OC initiation was 4.5 kg. A trend toward greater
median weight loss was noted at week 4 in patients eventually initi-
ating OC use (–1.4 kg), compared with those who did not (–1.0 kg).
Weight loss stabilized one month after OC initiation (median 0.5 kg
additional loss). Interferon dose reductions were rare and did not dif-
fer by OC use (8% of OC recipients versus 5% of nonrecipients).
The proportions of patients completing a full course of HCV therapy
and achieving a sustained virological response were greater in OC
CONCLUSIONS: The present retrospective cohort analysis found
that OC use is often effective in managing HCV treatment-related
symptoms that contribute to weight loss, and may stabilize weight
decline once initiated.
Key Words: Anorexia; HCV; Interferon; Oral cannabinoid;
Évaluation de médicaments oraux à base de
cannabinoïdes pour la prise en charge de
l'anorexie, des nausées et de la perte de poids
induites par l'interféron et la ribavirine chez
des patients traités pour l'hépatite C
OBJECTIFS : Les effets secondaires systémiques et cognitifs du traitement de
l’hépatite C (VHC) peuvent être invalidants et nécessiter des réductions de dose
ou l’arrêt du traitement. Les médicaments oraux à base de cannabinoïdes
(MOC) soulagent les nausées et les vomissements induits par la chimiothérapie
et corrigent le syndrome d’émaciation lié au sida. L’efficacité des MOC dans la
prise en charge des effets secondaires liés au traitement du VHC est inconnue.
MÉTHODES : Tous les patients qui ont débuté un traitement par inter-
féron-ribavirine à la clinique de traitement de l’hépatite virale de
l’Hôpital d’Ottawa (Ottawa, Ontario) entre août 2003 et janvier 2007
ont été recensés à l’aide d’une base de données cliniques informatisée. Les
caractéristiques de départ des receveurs de MOC ont été comparées à
celles des non-receveurs. La réponse aux MOC sur le plan des effets sec-
ondaires liés au traitement contre l’hépatite a été évaluée au moyen du
test du χ2. Les paramètres thérapeutiques clés avaient trait au poids, à la
réduction de la dose d’interféron et à l’issue des traitements et ont été
évalués au moyen des tests t de Student et du χ2.
RÉSULTATS : Vingt-cinq patients sur 191 (13 %) ont commencé à prendre
des MOC. Les receveurs présentaient les mêmes caractéristiques que les non-
receveurs, outre des antécédents d’utilisation de marijuana (24 %, contre 10 %,
respectivement, p = 0,04). La durée médiane avant le début des MOC était de
sept semaines. Les indications les plus courantes pour l’instauration des MOC
étaient l’anorexie (72 %) et les nausées (32 %). Soixante-quatre pour cent de
tous les patients qui ont reçu des MOC ont connu une amélioration subjective
de leurs symptômes. La perte de poids médiane avant l’instauration des MOC
était de 4,5 kg. Une tendance à une perte de poids médiane plus accentuée a été
notée à la semaine 4 chez les patients qui ont éventuellement commencé à pren-
dre des MOC (– 1,4 kg), comparativement aux non-receveurs (– 1,0 kg). La
perte de poids s’est stabilisée un mois après le début des MOC (perte de poids
médiane additionnelle (0,5 kg). Les réductions des doses d’interféron ont été
rares et n’ont pas différé selon l’utilisation ou non des MOC (8 % des
receveurs, contre 5 % des non-receveurs). Les proportions de patients ayant
complété leur cycle de traitement anti-VHC complet et ayant obtenu une
réponse virologique soutenue ont été plus grandes chez les receveurs de MOC.
CONCLUSION : La présente analyse de cohorte rétrospective a révélé
que l’utilisation des MOC est souvent efficace pour la prise en charge des
symptômes liés au traitement du VHC qui contribuent à la perte de poids
et pourrait stabiliser la perte pondérale lorsqu’elle est débutée.
©2008 Pulsus Group Inc. All rights reserved
espite the efficacy of hepatitis C virus (HCV) antiviral ther-
apy (1-5), the physical and cognitive side effects of
interferon-ribavirin-based regimens are numerous. Most patients
experience persistent side effects including fatigue, headache,
nausea, anorexia, depressive symptoms and insomnia (6-9). These
symptoms can be incapacitating and may necessitate dose reduc-
tion or abandonment of therapy. This is not ideal, because subop-
timal dosing of interferon-ribavirin results in diminished sustained
virological response (SVR) rates (3). Adjunctive therapy such as
antiemetics, anxiolytics and sleeping agents are frequently
employed to assist patients with these side effects. Unfortunately,
these adjunctive agents are often insufficient (7-9).
Although formal studies are lacking, there is anecdotal evi-
dence that cannabis may be beneficial by alleviating common
side effects associated with interferon-ribavirin, including
anorexia, nausea, weight loss and insomnia (10-15). Despite
the potential benefits of cannabis, concerns related to the
long-term medical complications of inhaled cannabis use and
the inability to legally obtain this product limit the use of it as
a therapeutic intervention.
Oral cannabinoid-containing medications (OCs) have
multiple potential therapeutic uses due to their analgesic,
antiemetic, anticonvulsant, bronchodilatory and anti-
inflammatory effects (16). They have been shown in clinical
trials to ameliorate chemotherapy-induced nausea (17,18), to
benefit those with AIDS wasting syndrome (19) and to reduce
spasticity in multiple sclerosis patients (20).
We conducted a retrospective study to describe the use of
OCs in an HCV-infected population receiving interferon-
ribavirin therapy to quantify the potential efficacy of these
agents in relieving anorexia, nausea, vomiting and insomnia.
We also examined the effect of OCs on weight loss. We further
compared interferon-ribavirin dose reduction, HCV treatment
duration and SVR rates between patients receiving OC versus
PATIENTS AND METHODS
All patients who initiated interferon-ribavirin therapy at The
Ottawa Hospital Viral Hepatitis Clinic (Ottawa, Ontario)
between August 2003 and January 2007 were identified using a
computerized clinical database (SPSS 13.0, SPSS Inc, USA).
This time frame was selected, because OCs were not routinely
used in the clinic before August 2003. The present study’s work
was conducted with Ottawa Hospital Research Ethics Board
approval. Data from the most recent HCV therapy were used in
those receiving more than one round of treatment. Baseline
characteristics of all patients were compared between recipients
of OCs (ie, Cesamet [Valeant Canada, Limited, Canada] and
Marinol [Solvay Pharma Inc, Canada]) and nonrecipients.
A descriptive analysis of the HCV-infected population
receiving interferon-ribavirin therapy, stratified by OC use, was
compiled. Data capture was censored as of January 15, 2007. The
proportion of OC recipients who achieved relief of anorexia,
nausea, vomiting and insomnia was calculated. Trends in weight
loss, HCV antiviral dose reduction, duration of HCV therapy,
discontinuation rates and SVR were compared between OC
recipients and nonrecipients by Student’s t test and χ2analysis.
Significance was defined as P<0.05.
Twenty-five of 191 patients (13%) initiated OC use (Cesamet,
n=16; Marinol, n=9). This represented 866 person-weeks of
interferon-ribavirin exposure in those who initiated OC use
and 4323 person-weeks in those who did not. Baseline charac-
teristics are described in Table 1. The characteristics of recipi-
ents were similar to those of nonrecipients, aside from prior
marijuana smoking history (24% versus 10%, respectively;
P=0.04). A higher proportion of patients with genotype 1
infection received OC. This was likely a consequence of
receiving HCV therapy for 48 weeks, as opposed to 24 weeks
for infection with genotypes 2 and 3.
Starting dates, initial doses and frequency of dosing of
OCs were highly variable. The median time to OC initiation
was week 7 (quartiles 2, 7, 18). Some patients used the med-
ication routinely, while others used it on an as-needed basis.
The most common indications for initiating OC use were
anorexia (72%) and nausea (32%), with 67% and 75% of
recipients, respectively, achieving subjective improvement in
these symptoms. Insomnia was a rare indication for OC use
(n=2) (Table 2).
The median weight loss following the start of HCV therapy
and before OC initiation was 4.5 kg. A trend toward greater
median weight loss was noted at weeks 2 (–1.5 kg) and 4
(–1.4 kg) of HCV treatment in patients who initiated OC use,
Oral cannabinoids for HCV treatment symptoms
Can J Gastroenterol Vol 22 No 4 April 2008377
Baseline characteristics of hepatitis C virus (HCV)
treatment recipients, stratified by oral
cannabinoid-containing medication (OC) use
Yes (n=25)No (n=166)
Age, years, mean ± SD 44±743±10
Weight, kg, mean ± SD78±19 79±17
HCV RNA, copies/mL, mean ± SD1.1×106±1.7×106
ALT level, U/L, mean ± SD73±52101±78
Sex, n (%)
Male18 (72)125 (75)
Female7 (28) 41 (25)
HCV genotype, n (%)
1 18 (73)102 (61)
2 2 (8)20 (12)
3 5 (20)39 (23)
4 0 (0)5 (3)
Ethnic background, n (%)
White24 (96) 148 (89)
Other1 (4) 18 (11)
Country of birth, n (%)
Canadian-born22 (88)138 (83)
Immigrant3 (12) 28 (17)
Liver biopsy stage (METAVIR), n (%)*
0–210 (53)67 (68)
3–49 (47) 32 (32)
HIV coinfection, n (%)5 (20)14 (9)
Psychiatric illness history13 (52) 86 (52)
Injection drug use history18 (72) 98 (59)
Excess alcohol use history18 (72)100 (60)
Alcohol or drug abuse history22 (88)130 (78)
Marijuana smoking history6 (24)16 (10)
*Nineteen of 25 patients and 99 of 166 patients underwent pretreatment liver
biopsy. ALT Alanine aminotransferase
compared with those who did not use OC (–1.0 kg at each
time point) (Note – this analysis excluded patients who began
OC use in the initial four weeks of HCV therapy). Weight loss
stabilized one month after the initiation of OC use (median
0.5 kg additional loss). Figure 1 illustrates trends in weight loss
between those eventually starting OC use and nonrecipients.
Interferon dose reductions were rare and did not differ by
OC use (two of 25 OC recipients versus eight of 166 nonre-
cipients). This reflects a strict practice policy at The Ottawa
Hospital Viral Hepatitis Clinic to avoid any interferon or rib-
avirin dose reduction, except as a last resort. A similar pro-
portion of patients completed at least 12 weeks of HCV
therapy, irrespective of OC use (Table 3). The proportion of
patients completing a full course of HCV therapy
(ie, 48 weeks for genotypes 1 and 4, and 24 weeks for geno-
types 2 and 3) was 78% in OC recipients and 49% in those
who did not initiate this class of medication (P=0.02). The
proportion of patients achieving a SVR was greater in OC
recipients (79%) than in nonrecipients (52%, P=0.07). A
sensitivity analysis was conducted, which was restricted to
patients who initiated OC use before week 12 (ie, those who
failed to achieve an early virological response (EVR) would
have interrupted HCV therapy and never had the opportu-
nity to subsequently initiate OC use, thereby biasing the
SVR results in favour of OC users). Seventeen of the
25 patients who initiated OC use did so before week 12. The
EVR rate was 92% in OC recipients versus 78% in nonrecip-
ients (P=0.22). The SVR rate was 67% in OC recipients ver-
sus 52% in nonrecipients (P=0.29). All results were similar
when a sensitivity analysis was conducted that excluded
marijuana-smoking patients (data not shown).
In general, OCs were well tolerated. Five recipients
reported a minor side effect that was attributed to OC use. Side
effects included sedation (n=1), dizziness (n=1), headache
(a single episode) (n=1) and nonspecific malaise attributed to
OC use (n=2). In three cases, OC use was discontinued
because of side effects attributed to these medications. None of
these side effects would be classified as severe adverse events.
No case of abuse or addiction was identified.
Cannabinoids work via two known receptors – cannabinoid
receptor (CB) 1 and CB2. Neurological and behavioural effects
are mediated via CB1, which is expressed in peripheral neurons
and the basal ganglia, cerebellum and hippocampus (21). This
distribution of cannabinoid receptors also contributes to the
observed benefit of OC use for chemotherapy-induced nausea
(17,18) and AIDS-related weight loss (19).
In our clinical experience, OC use is often effective in
managing HCV treatment-related symptoms that contribute
to weight loss. It is our practice to avoid any HCV antiviral
dose reduction unless absolutely necessary. The use of OC as
an effective alternative therapy serves to preserve full thera-
peutic doses of HCV treatment. In the present study, precipi-
tous weight loss in the first four weeks of HCV therapy was a
marker of eventual OC prescription. We found that anorexia
and nausea were managed effectively in most recipients of OC.
We suspect that this, in turn, led to diminished additional
weight loss following OC initiation.
Costiniuk et al
Can J Gastroenterol Vol 22 No 4 April 2008378
Reasons for initiating oral cannabinoid-containing
medication use and the corresponding outcomes
Proportion of improvement, as per
Indicationn patients, %patient report, n (%)
Anorexia1872 12 (67)
Nausea8 32 6 (75)
Vomiting3 122 (67)
Insomnia28 0 (0)
Composite indication*25– 16 (64)
*Some patients had multiple indications for oral cannabinoid-containing med-
Comparison of dose reductions, discontinuations and
hepatitis C virus treatment outcomes between controls
and oral cannabinoid-containing medication (OC)
No OC prescribed,OC recipients,
% (n/total)% (n/total)P
Patients requiring interferon 5 (8/166) 8 (2/25) NS
Patients requiring ribavirin 10 (17/166) 8 (2/25) NS
At least 12 weeks of 89 (118/132) 94 (17/18) NS
Full duration of 49 (65/132)78 (14/18) P=0.02
Sustained virological52 (53/101) 79 (11/14)P=0.07
Significance was defined as P<0.05. *Patients still on therapy at the time of
data censorship were not included in this analysis (n=34 in the non-OC group
and n=7 in OC recipients); †The full duration of therapy was 48 weeks for
genotypes 1 and 4, and 24 weeks for genotypes 2 and 3; ‡Patients who did
not yet reach the six months after completion of therapy point at the time of
analysis have been excluded. NS Not significant
0 2 4 6 8 12
Week of HCV treatment
Figure 1) Comparison of weight loss during hepatitis C virus (HCV)
treatment between those eventually initiating oral cannabinoid-
containing medication use (solid line) and nonrecipients (dashed line).
This analysis excluded patients who began oral cannabinoid-containing
medication use in the initial four weeks of HCV therapy
Oral cannabinoids for HCV treatment symptoms
Can J Gastroenterol Vol 22 No 4 April 2008379
Our findings are consistent with those of Sylvestre et al (22)
in demonstrating that the amount of HCV drug exposure while
on treatment and the duration of time that patients remain on
therapy can be increased with the use of cannabinoids. These
benefits likely contributed to the improved SVR rates observed
in our population of patients. Our study does differ from that of
Sylvestre et al in several key ways. While our patients used
pharmaceutical grade OCs, the Sylvestre et al cohort smoked
marijuana. Furthermore, the study by Sylvestre et al was con-
fined to patients on methadone maintenance therapy.
The only pretreatment characteristic more frequently iden-
tified in those eventually receiving OC was a history of mari-
juana smoking. This is likely a marker of greater willingness to
use cannabinoid-containing medication. We have found that
patients are often hesitant to initiate these medications, given
the stigmata attached to marijuana use and concerns related to
addiction or criminal activity. An effort to educate patients
about the potential benefits, low risks and negligible addiction
risk of OCs may be an effective approach to mitigate these con-
cerns. Additional concerns are that the provision of OCs may
represent the exchange of one substance of abuse for another or
that the prescription of OCs may enable substance abusing ten-
dencies. In fact, there is little evidence to support abuse or
diversion of OCs (23,24). Nonetheless, a personal observation
in the clinic setting is that the occasional patient will seek OC
prescriptions for the purpose of trafficking.
CB2 receptors are present on B lymphocytes and natural
killer cells (25). Concerns related to potential immunosuppres-
sive properties of cannabinoids have been raised (26-28).
Because CB1 and CB2 receptors may be expressed on hepatic
myofibroblasts, cannabinoids may also influence liver disease
progression (27,29). In the present study, the use of OC was
associated with minimal adverse events, which is consistent
with other studies (30-32). Although our analysis raised no
concerns related to the safety of OC use in combination with
immunosuppressive HCV therapy or with regards to liver sta-
tus, additional evaluations of the long-term immunological and
hepatic effects of OCs are warranted.
There are limitations to consider when interpreting this
work. Our study employed a retrospective cohort design and, as
such, is subject to issues related to incomplete data for some
parameters and to bias. Survival bias (ie, remaining on HCV
treatment long enough to initiate OC use) must be considered
when interpreting treatment outcomes. The proportion of
patients completing a full course of HCV therapy and achiev-
ing a SVR was greater in OC recipients. However, patients
without EVRs discontinued HCV therapy early, did not suffer
further HCV treatment-related side effects and therefore did
not start OC. We attempted to control for this by sensitivity
testing, but recognize that further analyses are necessary before
concluding that OC use improved SVR rates. Our sample size
of OC recipients was relatively small. However, the effects
between groups appear large and remain following sensitivity
Despite these concerns, this evaluation of a well-described
HCV treatment recipient cohort demonstrates the efficacy of
OCs for the management of therapy-related anorexia, nausea
and weight loss. As a consequence of better side effect man-
agement, patients may be better able to complete a full course
of treatment and achieve higher SVR rates.
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