July 12, 2010

Prevent and Protect Yourself from Hepatitis

Posted by Bea Lang on Monday, July 12, 2010, 13:49

Hepatitis is a liver disease that makes you feel like you have the flu. Several different viruses called the hepatitis A, B, C, D and E viruses can cause hepatitis, but researchers believe others might cause the disease as well. These viruses attack your liver and keep it from working right. This can make you feel tired and sick to your stomach. You could get a fever, lose your appetite or have stomach pain, diarrhea, dark yellow urine or light-colored stools. You may even develop yellowish eyes and skin. All the hepatitis viruses can cause acute, or short-term, hepatitis. Some can also cause chronic hepatitis, in which the infection lasts a long time, sometimes for your whole life. Chronic hepatitis can eventually lead to scarring of the liver tissue, liver failure and liver cancer. Some forms of hepatitis get better on their own, but others can inflict serious liver damage, and may even leave you needing a new liver.

You can’t live without a functioning liver. The liver clears poisons from your blood and helps control infections. It also makes proteins involved in blood clotting and the bile that helps you absorb fats and vitamins. While the liver can heal itself to some extent, repeated or extensive damage can overwhelm it.

Different hepatitis viruses spread in different ways. Hepatitis A, the most common, is spread through food or water contaminated by feces from a person who has the virus. Hepatitis B, the next most common type, is spread through contact with an infected person’s blood, semen or other body fluid. Hepatitis C and D are spread through contact with an infected person’s blood. Hepatitis E spreads the same way as hepatitis A does, but is not common in the U.S. The U.S. Centers for Disease Control and Prevention recommends vaccination for hepatitis A to children ages 12- to 23-months old as well as for adults at high risk for infection and for hepatitis B, all infants and unvaccinated children, adolescents and at-risk adults should get it.

While there are treatments for some types of hepatitis, it is still a potentially dangerous disease. To prevent it Wash your hands after going to the bathroom and before fixing food or eating, use latex condoms, which may lower the risk of transmission, avoid tap water when traveling to certain countries or regions, don’t share drug needles, and don’t share personal items—such as toothbrushes, razors and nail clippers—with an infected person.

If you do get hepatitis, several medications are available to treat hepatitis B and C, and other drugs are being developed and evaluated. Most people with hepatitis A get well on their own after a few weeks. By young adulthood, most who get acute hepatitis B infections also recover on their own. Infected newborns, however, are more likely to progress to chronic hepatitis B.

NIH continues to support research into the nature and transmission of the hepatitis viruses, as well as new treatments and methods of prevention. In the meantime, the best way to prevent hepatitis is to reduce your risk of being exposed to these viruses. If you suspect you might have hepatitis, see your doctor for a blood test.


FDA Approves Infergen Combo Therapy for Retreating HCV

Yael Waknine

July 12, 2010 — The US Food and Drug Administration (FDA) has approved an expanded indication for interferon alfacon-1 subcutaneous injection (Infergen; Three Rivers Pharmaceuticals, LLC), in combination with ribavirin, for retreatment of chronic hepatitis C (HCV) viral infection.

The action was based on data from the United States–based Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy clinical trial of nonresponders to prior pegylated interferon plus ribavirin therapy who were randomly assigned to receive active treatment or placebo for up to 48 weeks.

Results showed that 9% of patients receiving 15 μg interferon alfacon-1/ribavirin achieved a sustained virologic response, defined as undetectable HCV RNA levels at 24 weeks posttherapy (vs placebo, 0%).

The retreatment strategy was especially effective for interferon-sensitive patients with lower baseline fibrosis scores. According to a company news release, up to 38% of noncirrhotic patients who were sensitive to pegylated interferon/ribavirin and who did not modify their interferon alfacon-1/ribavirin dosages achieved a sustained virologic response. Cirrhotic patients were less likely to benefit from treatment unless they displayed previous interferon sensitivity or a minimum 1 log10 drop in HCV RNA on prior therapy.

"Approximately 50 percent of patients with chronic hepatitis C do not respond to their initial course of therapy," stated Bruce Bacon, MD, in the company news release. "The FDA's recognition of this expanded label allows patients failing therapy a safe and efficacious retreatment strategy. The results from this study legitimize how we properly treat these patients helping them to achieve [a sustained virologic response]." Dr. Bacon was the lead investigator for the registration trial.

Adverse events most commonly reported with 15 μg interferon alfacon-1/ribavirin included fatigue, nausea, influenza-like symptoms, headache, arthralgia, myalgia, neutropenia, leukopenia, insomnia, and depression. Dose modifications were required in 52% of patients, primarily because of neutropenia/leukopenia, thrombocytopenia, and fatigue/weakness.

Interferon alfacon-1 previously was approved as monotherapy for chronic HCV in adults with compensated liver disease.

Also See:
Consensus Interferon (Infergen) Label Changed to Include Data on Dosing with Ribavirin
Three Rivers Pharmaceuticals Announces FDA Approval Of Expanded Labeling of INFERGEN®

Newly Discovered Hepatitis C-Related Virus Found in Bats

Wildlife Trust Scientist Employs Advanced Genetic Sequencing to Uncover New Pathogen

NEW YORK, July 12 /PRNewswire-USNewswire/ -- Wildlife Trust, the global conservation health organization, announced the discovery of a previously unknown pathogen that may offer insight into the origins of the Hepatitis C virus. The virus, tentatively named GBV-D, is related to a group of GB viruses, previously only known to occur in monkeys and humans. Dr. Jonathan Epstein, Associate Vice President of Conservation Medicine Programs at Wildlife Trust, reveals in a paper published in PLoS Pathogens that the new viral discovery is part of a large family of viruses, called Flaviviridae, which includes the Hepatitis C virus, GB viruses and others. Viral hepatitis affects more than 500 million people worldwide and is the leading cause of liver failure and liver cancer.

Wildlife Trust scientists are actively surveying wildlife species, such as bats, for viruses that may threaten human health in key regions all over the world that are highly vulnerable to disease emergence. The team was actively testing bats for the deadly Nipah virus that infects and kills people each year in Bangladesh. It is estimated that infectious diseases lead to 13 million human fatalities per year. Additionally, over three-quarters of emerging infectious diseases are a result of zoonotic pathogens.

Bangladesh is a notable emerging disease hot spot due to its dense population and the close association between wildlife and humans. Scientists tested 100 giant fruit bats, Pteropus giganteus, in the Faridpur region of the country. "Bangladesh is densely populated and large colonies of bats roost in close proximity to people. We know from studying Nipah virus that bat viruses can be transmitted to people through food-borne pathways," said Dr. Jonathan Epstein.

Bats are known to be the reservoir for many zoonotic viruses including rabies, Ebola, Marburg, Hendra, Nipah, and SARS. Wildlife Trust is working to predict and prevent emerging diseases by actively testing wildlife in critical hot spots around the world. "The Indian subcontinent and South Asia are areas where we are ardently working to identify the next possible pandemic disease," stated Dr. Peter Daszak, President of Wildlife Trust.

In the lab, the bat blood samples were analyzed using high-throughput pyrosequencing – an emerging platform for DNA analysis. The technology has helped scientists improve genomic sequencing and enabled Dr. Epstein to discover the new GBV-D virus. "It's essential to understand if and how viruses are being transmitted from animals to people in an outbreak setting such as SARS, but it's equally important to identify the natural reservoir of the virus, which may not be directly infecting people, to ensure that more outbreaks don't happen in the future," said Dr. Epstein. "With our preliminary research it's too early to tell if GBV-D could cause disease in human populations. Our next steps will require testing people that come in contact with these bats to gauge possible infections."

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.

Peter Daszak

Jonathan Epstein

SOURCE Wildlife Trust



Also See: Discovery of a hepatitis C-related virus in bats may reduce outbreaks in humans

HIV & Hepatitis C: Coping with Coinfection (Part 1 and Part 2)

HIV & Hepatitis C: Coping with Coinfection (Part 1)

Bova, Ogawa, and Sullivan-Bolyai (2010) report that "an estimated 25% to 40% of HIV-infected patients are also infected with HCV [hepatitis C virus], and in some practices the prevalence is as high as 75% to 90%. . . . Recent estimates suggest that approximately 250,000 persons are coinfected with HIV and HCV in the United States" (p. 63), "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. . . . Studies show that a majority of coinfected patients have at least moderate liver inflammation or other signs of disease progression, . . . 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 eligible for HCV treatment, and under 10% actually receive treatment" (Wagner et al., 2009, p. 715).

Increasing attention has been directed to individuals coinfected with HIV and HCV because in patients infected only with HCV, the time between infection and development of fibrosis [scar tissue resulting from inflammation of the liver] averages 20 years, whereas in patients coinfected with HIV/HCV, liver disease may develop in 5 to 10 years. . . . [Additionally,] HCV infection . . . influences the course and management of HIV disease, particularly by increasing the risk of ART-induced hepatotoxicity [liver damage]. . . . The goal of HCV treatment is to achieve a sustained virologic response (SVR), which is defined as the absence of serum hepatitis C RNA for 24 weeks after treatment completion. . . . Without HCV treatment, increasing numbers of HIV-infected patients will die either from end-stage liver disease or from HIV-related complications resulting from the inability to use antiretroviral agents because of their hepatotoxicity. (Bova et al., 2010, p. 64)

This is the first of a two-part series. Part 1 provides a medical, psychiatric, psychosocial, and neuropsychological overview of HIV/HCV coinfection, the process of determining eligibility for HCV treatment, and the important role mental health clinicians play in assessing eligibility and intervening with clients who elect to receive treatment for HCV.

Part 2 (to be presented in the Summer 2010 issue of mental health AIDS) will expand on how providers make the decision to offer HCV treatment to individuals living with HIV and chronic HCV infection, how coinfected individuals make decisions to accept or defer treatment for HCV, and the latest thinking on HCV-treatment interventions.

The Chance of a Cure

"A patient's willingness to undergo HCV treatment is likely influenced by how the patient views the efficacy and burden or risk of treatment" (Osilla et al., 2009, p. 993).

On the question of efficacy, it's important to know that "at least six distinct genotypes (numbered 1-6) and more than 30 subtypes of HCV are known," but "the most common genotype present in the United States, genotype 1, is also the most resistant to treatment" (Bova et al., 2010, pp. 63-64). According to Osilla et al. (2009), "standard HCV treatment, which consists of 48 weeks of weekly pegylated interferon (PEG-IFN) injections in combination with daily ribavirin (RBV), . . . has demonstrated a success rate of 30%-45% among HIV coinfected patients across all genotypes, . . . but only 17%-29% among HIV patients with . . . HCV . . . genotype 1" (p. 993). Although "new treatment agents (e.g., protease and polymerase inhibitors) that may improve treatment efficacy are at various stages of development and testing, . . . [they] are not expected to be available for routine practice for at least a few years and [IFN] will remain a component of treatment" (Wagner et al., 2009, p. 715).

As for the risks involved, treatment for HCV has been characterized as "lengthy, rigorous, and associated with side effects that are difficult to manage" (Silberbogen, Ulloa, Janke, & Mori, 2009, p. 114). "Flu-like symptoms (nausea, diarrhea, weight loss)" and "fatigue associated with hematologic abnormalities (anemia, neutropenia) . . . [are] highly prevalent" (Wagner et al., 2009, pp. 715-716). "In addition to physiological side effects, there are also significant neuropsychiatric side effects, including depression, anxiety, irritability, psychosis, suicidality, apathy/malaise, fatigue, impaired concentration, anhedonia, and recurrence of posttraumatic stress disorder symptoms" (Silberbogen et al., 2009, p. 114).

"Not surprisingly, a general fear and apprehension regarding side effects and their impact on quality of life and functioning are common among patients considering treatment" (Osilla et al., 2009, p. 993), and Wagner and colleagues report "dropout rates as high as 40%-50% in community samples of coinfected patients" (p. 716). Yet, "despite these side effects and related patient concerns," proponents of HCV treatment "recommend early treatment for coinfected patients to prevent more serious disease development" (Osilla et al., 2009, pp. 993-994) and "can argue that PEG-IFN/RBV, unlike ART, has a limited duration and at least a chance of a cure" (Wagner et al., 2009, p. 716; see also neuropsychology sidebar).

The Offer of Treatment

"Upon detection of HCV infection, for treatment to be provided, providers must first consider a patient an appropriate treatment candidate, and multiple medical and psychosocial factors can contribute to a provider's reluctance to recommend or offer treatment to a patient" (Osilla et al., 2009, p. 993). In a Seattle HIV-specialty clinic, for example, among 248 predominantly white and male, HCV/HIV-coinfected patients, fewer than half . . . were evaluated for possible [IFN]-based HCV treatment. Only 16% received treatment, and only 2.4% of the entire cohort achieved an SVR. The median time to evaluation for treatment was almost 3 years, a significant period of delay in patients who may have a much more rapid progression to cirrhosis [the final stage of fibrosis], compared to patients without HIV. . . . Similarly, the median time elapsing between evaluation and treatment initiation was 1.4 years. Substance abuse and advanced HIV infection were the primary reasons for nonevaluation. (Scott et al., 2009, p. 928)

According to Wagner and colleagues (2009), substance abuse and mental illness each account for 20%-30% of coinfected patients being deemed ineligible for treatment, as clinicians are concerned that the side effects of HCV treatment may lead to psychiatric deterioration, relapse into substance abuse, poor adherence, and treatment discontinuation. . . . 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 treatment, . . . 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. (p. 716)

For this reason, mental health clinicians are often called upon to conduct a psychological evaluation to determine appropriateness for this course of treatment. . . . A pre-treatment psychological evaluation should assess for those factors that will maximize the likelihood of a successful treatment course. Therefore, clinicians should assess for: psychiatric stability and safety (e.g., suicidal ideation, uncontrolled depression), current and past substance use and abuse, knowledge and expectations about treatment for HCV, motivation and ability to adhere to treatment, and psychosocial support.1 . . . After an assessment, clinicians can help prepare patients for treatment by providing education, establishing realistic expectations of treatment success, developing stress-management skills, and identifying areas of concern that patients and/or providers can monitor throughout the course of treatment. Also, a clinician can discuss the potential benefits of a referral for psychiatry consultation to consider psychotropic medication. However, it is important to note that there have been few large-sample, controlled studies evaluating the benefits of prophylactic psychotropic medications in HCV patients on IFN treatment, and that studies with small sample sizes have found inconsistent results. (Silberbogen et al., 2009, p. 117; see alsopsychiatry sidebar)

The Role of the Mental Health Clinician

Silberbogen and colleagues (2009) "have identified areas in which clinicians can intervene [with patients diagnosed with HCV]; these include adjustment to having a chronic medical illness, coping with stigma and relationship changes, management of side effects, and implementing healthy lifestyle changes" (p. 114). Some of the recommendations from these authors in each of these areas follow:

Adjustment to having a chronic medical illness - At the time of diagnosis with HCV, "a mental health clinician can help a patient to process this new diagnosis, generate effective coping strategies, facilitate communication between the patient and hepatologists, and serve as a resource for patients' questions and concerns while providing stability and support" (p. 115). In fact, a key role for the mental health clinician is to ensure that HCV-positive patients have a thorough understanding of their diagnosis and to help translate this knowledge into behavioral change. A well-informed clinician can assess patients' current level of understanding, correct inaccurate beliefs, increase their base of knowledge, and help patients set behaviorally-based goals consistent with treatment recommendations.

Although education may be sufficient to assist some during this adjustment process, other patients may benefit from counseling that helps them to make sense of this diagnosis. Cognitive-behavioral stress-management interventions have proven effective in reducing depressive symptoms and enhancing benefit-finding, positive reframing, and perceived social support in chronic medical populations, including those with HIV. . . . Stress- and anger-management interventions are likely to benefit patients struggling with the unpredictability that often accompanies the diagnosis of a chronic illness. Mental health clinicians can also help patients to identify areas of their life in which they can exert some control (i.e., response to stressors) that may counterbalance these negative psychological sequelae. (pp. 115-116) Coping with stigma and relationship changes - Clinician can help individuals living with HCV to "identity ways to buffer themselves from the impact of stigmatization, such as building a supportive network of friends, family, and medical providers, advocating assertively for . . . [their] needs, and learning how to disclose information while being self-protective. Therapy can also focus on enhancing patients' self-esteem by identifying and building on their positive attributes. Some patients may find value in activities that give them a sense of purpose (e.g., public-awareness programs, political advocacy)" (p. 116). In addition, "mental health clinicians can assist individuals with HCV to navigate . . . changes within their social support network. Communication and problem-solving skills training specifically focused on managing role-changes may prove beneficial, as well as acceptance-based work. Also, participation in couples or family therapy can allow patients to practice these skills in a supportive environment" (p. 116).

Finally, clinicians can help patients build their social support networks by treating mood disorders that interfere with social efforts and by setting small goals toward increased socialization. Clinicians can also assist HCV patients to identify and enhance existing relationships that they may initially overlook or discount. Patients may find it beneficial to engage in "safer" outlets for social interaction, such as online support communities, volunteer positions, or psycho-educational/support groups for patients with HCV, liver disease, or chronic medical conditions. Support groups can be a useful source of information and connection for patients with chronic illness. Mental health providers can make an important contribution to the care of patients with HCV by organizing and/or facilitating support groups focused on issues relevant to this patient population. In addition to providing much-needed social support, these groups can provide education, promote positive health behaviors, and moderate experiences of stigma or discrimination. (p. 117)2

Management of side effects - Once treatment has been initiated, mental health clinicians can use brief standardized measures (e.g., the Beck Depression Inventory) . . . to monitor the presence and severity of psychiatric symptoms . . . and can address specific symptoms in the context of therapy. Stress-management (e.g., relaxation exercises, problem-solving practice), behavioral activation, cognitive restructuring, and enhancement of self-care behaviors (e.g., exercise, proper diet, sleep hygiene) are useful strategies for minimizing potential side effects. Clinicians are also in an excellent position to provide feedback to medical staff, such as psychiatrists, should greater intervention be necessary (i.e., psychotropic medications). (pp. 117-118) In the area of medication adherence, "clinicians can help patients to identify and problem-solve barriers to treatment-adherence, assist in the organization and scheduling of medications, manage side effects, and facilitate access to medical providers" (p. 118).

Implementing healthy lifestyle changes - Because alcohol has a detrimental effect on liver functioning, "reduction in alcohol use is one of the most important behavioral changes patients can make to slow the rate of HCV progression" (p. 118), and "patients with an understanding of the relationship between HCV and alcohol use may be increasingly motivated to make and sustain healthy lifestyle changes" (p. 119). In support of this effort, mental health clinicians can work with patients to develop a concrete change plan based on their stated goals for treatment and anticipate challenges that may interfere with the execution of these goals. Also, patients on IFN treatment who have a history of alcohol abuse or dependence may benefit from ongoing monitoring and support from a clinician with experience in substance-abuse counseling, because the side effects of treatment may result in increased urges and cravings. . . .

Several standardized instruments, such as the Alcohol Use Disorders Identification Test (AUDIT) . . . or the Alcohol Abstinence Self-Efficacy Scale, . . . may prove useful to the clinician assessing and monitoring alcohol intake for patients with HCV. These brief measures are easy to administer and can be used to identify patients in need of additional intervention. All patients should be educated regarding the effects of alcohol on the course of HCV, and, when appropriate, should be evaluated by a chemical-dependency specialist. (p. 118)

Because cigarette-smoking can affect "liver health, treatment efficacy, and quality of life," clinicians are encouraged to review "evidence-based recommendations from research in general populations that can be used as guides for . . . assisting . . . HCV-positive patient[s] to quit smoking or reduce the amount that they smoke. . . . Goals of these recommendations are to increase screening, enhance motivation, and assist patients to reduce tobacco use through problem-solving techniques" (p. 119).

Since "it is likely that improved nutritional status will have a positive effect on disease-progression and long-term outcome for HCV-positive patients," mental health clinicians can take several steps to assist the HCV-positive patient to achieve his or her individual dietary goals. First, clinicians should encourage all HCV-positive patients to pursue a healthy diet and educate patients about how diet can affect their disease progression and quality of life. Unhealthy diet patterns should be identified (e.g., high-sugar and high-fat diets, high daily caloric intake, frequent fast-food consumption, limited fruit and vegetable intake) and addressed. Finally, referrals to nutrition services may be appropriate for some patients, particularly for cases in which the nutritional needs may require a unique or intensive intervention, such as with HCV-positive patients who are overweight/obese, those for whom there are concerns about iron overload, and those who have comorbid metabolic concerns, such as diabetes. (p. 119)

Additionally, with medical-provider approval, HCV-positive patients should be encouraged to participate in regular physical activity to address weight-management, quality of life, and symptom-management. Clinicians can assist HCV patients with setting exercise goals, enhancing motivation to exercise, addressing barriers to activities, and challenging any unhelpful thoughts that interfere with exercise. Devices such as pedometers may motivate patients who are ready to make changes in activity levels. When appropriate, a referral to rehabilitation or physical therapy services for exercise recommendations can be extremely useful. (p. 119) ----Compiled by Abraham Feingold, Psy.D.


Bova, C., Ogawa, L.F., & Sullivan-Bolyai, S. (2010). Hepatitis C treatment experiences and decision making among patients living with HIV infection. Journal of the Association of Nurses in AIDS Care, 21(1), 63-74.

Osilla, K.C., Ryan, G., Bhatti, L., Goetz, M., Witt, M., & Wagner, G. (2009). Factors that influence an HIV coinfected patient's decision to start hepatitis C treatment. AIDS Patient Care & STDs, 23(12), 993-999.

Scott, J.D., Wald, A., Kitahata, M., Krantz, E., Drolette, L., Corey, L., & Wang, C.C. (2009). Hepatitis C virus is infrequently evaluated and treated in an urban HIV clinic population. AIDS Patient Care & STDs, 23(11), 925-929. Silberbogen, A.K., Mori, D.L., & Sogg, S. (2005). The Structured Interview for the Treatment of the Hepatitis C Virus (SIT-HCV). Journal of Clinical Psychology in Medical Settings, 12(1), 57-69.

Silberbogen, A.K., Ulloa, E.W., Janke, E.A., & Mori, D.L. (2009). Psychosocial issues and mental health treatment recommendations for patients with hepatitis C. Psychosomatics 50(2), 114-122.

Wagner, G., Ryan, G., Osilla, K.C., Bhatti, L., Goetz, M., & Witt, M. (2009). Treat early or wait and monitor? A qualitative analysis of provider hepatitis C virus treatment decision-making in the context of HIV coinfection. AIDS Patient Care & STDs, 23(9), 715-725. -------------------- 1 One version of the pre-treatment psychological evaluation, "the Structured Interview for the Treatment of the Hepatitis C Virus (SIT-HCV), developed by the Medical Psychology Service at the VA Boston Healthcare System in collaboration with the VA Liver Clinic[,] . . . expands upon a standard psychiatric interview by addressing those psychological and behavioral factors that are unique to this population and essential to consider prior to recommending a patient for IFN therapy. . . . On the basis of the information gathered during the administration of the SIT-HCV, clinicians can make behavioral recommendations that will enhance a patient's likelihood of attaining an optimal treatment outcome while minimizing the impact of incapacitating side effects" (Silberbogen, Mori, & Sogg, 2005, p. 58). The complete protocol can be found in the appendix of Silberbogen and colleagues' article.

2 "As the nation's largest care-provider of patients with HCV, the [Department of Veterans Affairs] has developed a comprehensive website designed to meet both patients' and providers' needs (www.hepatitis.va.gov). . . . Available resources for mental health providers include a 'how-to' program guide that outlines the basic steps for initiating and maintaining a hepatitis C support group. This valuable resource includes a discussion of issues to consider when developing a group, suggestions for group topics, descriptions of therapeutic and facilitation techniques, and sample forms and handouts" (Silberbogen, Ulloa, Janke, & Mori, 2009, p. 117).

Neuropsychology of HIV/HCV Coinfection

"HCV mono-infection is associated with significant impairment in neuropsychological domains typically characterized as 'subcortical' in nature, with predominant impact on attention, information processing speed, and verbal memory. Further, evidence of neuropsychological impairment among HCV mono-infected individuals exists independent of comorbid substance abuse and severe liver disease, raising the possibility of direct brain involvement from HCV" (Martin-Thormeyer & Paul, 2009, p. 223). Moreover, individuals infected with both HCV and HIV express more severe neuropsychological impairment than individuals with HIV alone but the mechanisms underlying these effects remain unclear. To date a handful of studies have examined neuropsychological function among individuals co-infected with HCV and HIV. Among these studies there is notable variability in the methods to examine neuropsychological function, the use of various comparison groups (e.g., HCV alone, HIV alone, both mono-infected groups compared to co-infected patients), and the focus on various laboratory indices of disease burden. These methodological differences require some caution when drawing conclusions regarding the impact of co-infection on cognitive outcome. For example, a number of studies did not involve a comprehensive neuropsychological assessment, and therefore, conclusions regarding the neuropsychological pattern associated with co-infection remains premature. With that caveat noted, there is some suggestion in the literature that several domains of cognitive function are more likely impacted by co-infection than others.

Decreased processing speed and psychomotor speed among co-infected individuals is a commonly reported outcome of the studies . . . [although e]vidence of selective impairment in psychomotor speed/information processing is not universal. . . . [In fact, n]ot all studies have reported greater cognitive impairment among co-infected patients. . . . When taken collectively the majority of studies have reported more severe neuropsychological impairment among co-infected patients than mono-infected patients. (Martin-Thormeyer & Paul, 2009, pp. 224-225) Importantly, "recent studies of dually infected subjects indicate that neurocognitive function may improve with successful therapy for either disorder" (Gonzalez, Quartana, & Martin, 2009, p. 223).


Gonzalez, R., Quartana, P.J., & Martin, E.M. (2009). Co-occurrence of HIV, hepatitis C, and substance use disorders: Effects on brain functioning. In R.H. Paul, N.C. Sacktor, V. Valcour, & K.T. Tashima (Eds.), HIV and the brain: New challenges in the modern era (pp. 213-233). Totowa, NJ: Humana Press. Martin-Thormeyer, E.M., & Paul, R.H. (2009). Drug abuse and hepatitis C infection as comorbid features of HIV associated neurocognitive disorder: Neurocognitive and neuroimaging features [Review]. Neuropsychology Review, 19(2), 215-231.

Psychiatry & HIV/HCV Coinfection

According to Silberbogen and colleagues (2009), "numerous studies . . . document high prevalence rates of preexisting psychiatric disorders among patients with HCV. . . . Within the HCV-positive population, approximately 27%-78% of patients are diagnosed with past or current substance abuse, 15%-62% with mood disorders, and 30%-40% with anxiety disorders such as PTSD [posttraumatic stress disorder]" (p. 115).

With regard to the population of co-infected individuals, however, and "in the absence of established guidelines for the management of [the] psychiatric status of HIV/HCV-coinfected patients initiating PEG-IFN/RBV therapy," Weiss and Morgello (2009) "sought to determine what the state of practice is for providers actively engaged in the care of these patients" (p. 532). The investigators developed and reported on "a provider survey designed to determine whether consensus exists in the management of these patients and what factors might impact differing treatment approaches taken by health care providers" (p. 532). They focused in particular on "the use of prophylactic treatment with antidepressants [to] prevent . . . the development of depressive side effects during HCV treatment" (p. 532).

From a pool of 236 "expert" providers invited to participate, the sample consisted of 92 providers who completed the anonymous online survey, 26% of whom were psychiatrists. With regard to practice setting and provider discipline, Weiss and Morgello found that "the psychiatric management of HIV-coinfected patients being treated for HCV occurs in multiple contexts (varying from comprehensive integrated clinics to individual practices) and is done by providers from a wide range of disciplines (infectious disease, psychiatry, internal medicine, nurse practitioner). The survey was able to establish the practice patterns of expert providers who are predominantly physicians working in varied practice settings internationally" (p. 535).1 Notably, most of the nonpsychiatrist survey respondents have "very limited access to psychiatric consultation" (p. 535).

With regard to these practice patterns, more than one third of providers indicate[d] that they use or offer the option of antidepressant use prophylactically in HIV-positive patients with no past or current depression beginning HCV treatment, and more than three quarters do so in patients with a history of depression but no current symptoms of depression. The most experienced nonpsychiatrist providers were more likely to use antidepressants prior to the start of treatment in HIV-coinfected patients as compared to in HCV mono[-]infected patients. There . . . [wa]s consensus among providers to leave psychiatric medication unchanged in patients currently treated for unipolar depression. (p. 531)

Weiss and Morgello conclude that "many expert providers prescribe antidepressants to HIV/HCV-coinfected patients initiating [HCV] treatment in the absence of symptoms of depression, despite the lack of data supporting this approach in this population" (p. 531). The investigators surmise that "this pattern of prescribing . . . may be related to . . . limited access to psychiatric consultation, with providers viewing the prophylactic use of antidepressants as the safest and most cautious treatment approach" (p. 536). Weiss and Morgello advocate for "increasing [nonpsychiatrist] provider skills and competence through advanced training in psychiatric assessment and management[, because this] would likely reduce the extent to which these providers use antidepressants prophylactically and could potentially lead to better HCV treatment outcomes" (p. 536). Additionally (and importantly), "research is needed to provide an evidence base to guide the optimal psychiatric management of HIV/HCV-coinfected patients beginning [HCV] treatment" (p. 531).


Silberbogen, A.K., Ulloa, E.W., Janke, E.A., & Mori, D.L. (2009). Psychosocial issues and mental health treatment recommendations for patients with hepatitis C. Psychosomatics 50(2), 114-122.

Wagner, G., Ryan, G., Osilla, K.C., Bhatti, L., Goetz, M., & Witt, M. (2009). Treat early or wait and monitor? A qualitative analysis of provider hepatitis C virus treatment decision-making in the context of HIV coinfection. AIDS Patient Care & STDs, 23(9), 715-725.

Weiss, J.J., & Morgello, S. (2009). Psychiatric management of HIV/HCV-coinfected patients beginning treatment for hepatitis C virus infection: Survey of provider practices. General Hospital Psychiatry, 31(6), 531-537.

1 Wagner et al. (2009) point out that "unlike HCV mono-infected patients, who are typically treated by liver specialists (e.g., hepatologist or gastroenterologist) with extensive experience with HCV treatment, HIV coinfected patients are most often treated by HIV primary care providers (with relatively limited experience with PEG-IFN/RBV) because liver specialists are unavailable" (p. 716).
HIV & Hepatitis C: Coping with Coinfection (Part 2)
Part 1 of this series (presented in the Spring 2010 issue of mental health AIDS) provided a medical, psychiatric, psychosocial, and neuropsychological overview of HIV/hepatitis C virus (HCV) coinfection, the process of determining eligibility for HCV treatment, and the important role mental health clinicians play in assessing eligibility and intervening with clients who elect to receive treatment for HCV.
This concluding segment expands on how providers make the decision to offer HCV treatment to individuals living with HIV and chronic HCV infection, how coinfected individuals make decisions to accept or defer treatment for HCV, and the latest thinking on HCV treatment interventions.

What Providers Say

Wagner et al. (2009) documented "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 decisions, and the barriers to HCV treatment uptake, among HCV treatment-naïve HIV patients with chronic HCV infection" (p. 716). Among these three clinics, 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. (p. 715)

Wagner and colleagues' findings thus highlight

two approaches 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 appropriate 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 [HCV] 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 treatment 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 patients receive treatment, either earlier in the disease or later, given the high mortality associated with liver disease among HIV/HCV coinfected patients. (p. 723)

Of course, "provider decisions to recommend or offer treatment [are] critical to providing treatment access, but whether or not a patient starts treatment is ultimately in the hands of the patient" (Wagner et al., 2009, p. 723), "and 15%-30% of coinfected patients decline treatment. . . . Clearly, many patients perceive the risks of treatment to outweigh its benefits, though few studies have examined specifically how coinfected patients make HCV treatment decisions" (Osilla et al., 2009, p. 993). On this point, two recent studies examined how coinfected individuals make decisions regarding treatment for HCV.

What Their Patients Say

This same Los Angeles-based research team (Osilla et al., 2009) conducted semistructured interviews with 35 HIV/HCV coinfected patients at the same three HIV clinics and also drew data from their interviews with the 11 primary care providers included in the study by Wagner et al. (2009), for the purpose of exploring factors that influence the decision to initiate HCV treatment. The investigators interviewed "patients who had been offered treatment (n = 26) as well as those who had not (n = 9), and among patients who had been offered treatment, those who had started treatment (n = 17) as well as those who declined treatment (n = 9). The site coordinator at each clinic (a clinic staff member) identified a convenience sample of coinfected patients who represented these various treatment decision points and informed the patient[s] of the study to assess their interest in participating" (p. 994). Among these 35 patients, 31 (89%) were male, mean age was 49.8 years (standard deviation [SD] = 8.1), and 22 (63%) were non-Caucasian (12 Hispanic, 9 African American, 1 Asian). Patients reported being diagnosed with HIV between 1986 and 2005. All but two were currently on HIV antiretroviral therapy, and the mean self-reported CD4 count was 470 (SD = 250; range: 93-1000). Timing of HCV diagnosis ranged from 2 to 18 years prior to the interview. The majority (27/35; 77%) had a history of alcohol or drug problems, with the latter including use of marijuana, cocaine, methamphetamine, and heroin. Over half (56%) reported past injection drug use. In terms of current substance use, 27% reported some alcohol use and 19% reported drug use (mostly marijuana). (p. 995)

Additionally, the investigators conducted semistructured interviews with 11 primary care providers who were "the primary decision makers with regard to whether or not HCV treatment was recommended to patients. As part of these interviews, providers were asked about how their relationships with patients influenced the patient's decision to accept or refuse HCV treatment" (p. 994). Among the 26 patients who were offered treatment, "fear of treatment side effects and being uncertain of one's emotional stability and drug use were all concerns to patients who chose to refuse treatment" (p. 997). On the other hand, factors related to wanting to start treatment ranged from not wanting to waste time and the hope of being cured and being healthy, to feeling like there was nothing to lose by going on treatment, and a sense of trust and faith that their doctor would help them be successful with treatment. The most common factors across both groups of patients were perceived need to preserve physical health and survival, trust in the quality of relationship with one's provider, level of support for treatment within one's social network, and self-perception of treatment readiness. (p. 995)

Osilla and colleagues expand on these factors as follows:
Need for treatment to preserve physical health and survival. The most common reason patients reported for deciding to start treatment was concern over the effects of HCV disease on their physical health and related motivation to live and remain healthy, which was reported by 8 of the 17 patients (47%) who started treatment. . . . (p. 995)

Treatment readiness. One factor that strongly influenced decisions to start treatment as well as to defer treatment was a sense of personal readiness for treatment. How patients viewed or defined their readiness for treatment varied considerably. For some patients, feeling that their HIV disease was under control and stable implied a readiness to then take on HCV disease. . . . Others spoke of treatment readiness with regard to feeling ready to tolerate side effects, and being medically and psychologically stable. . . . Seven of the 17 (41%) patients who decided to start treatment expressed a confidence in being able to handle treatment side effects compared to only one of nine (11%) patients who refused treatment. . . . For many patients, treatment readiness was viewed in reference to a sense of stability in one's life Ð from feeling stable mentally and emotionally, to having substance use under control, and having a roof over one's head and being able to support oneself. Patients understood that treatment was going to be stressful and therefore they felt the need for more stability in their lives before starting treatment. . . . (pp. 995-996) Social support. While most patients expressed intrinsic reasons for wanting to start or defer treatment, several patients also referred to the influence of people in their social network.

Six of 17 patients (35%) who decided to start treatment stated that the HCV support group they attended was influential in their decision; HCV support groups were not mentioned at all by those who refused treatment, although it is not known whether these patients were members of such groups. Patients reported consulting with fellow patients about their experiences with treatment, including how they dealt with side effects and whether they viewed treatment as "worth it." Being able to address their fear of side effects with a patient actually in treatment or who had recently completed treatment helped dispel misunderstandings about the treatment. . . . (p. 996)

Doctor-patient relationship. When asked about the influence of the relationship with their doctor, 11 of the 17 (65%) patients who decided to start treatment reported that having a supportive doctor contributed to their decision compared to 2 of the 9 (22%) patients who refused treatment. While all patients in the study spoke favorably of their providers, it was the patients who decided to start treatment who often made especially strong statements about the quality of relationship they had with their doctor. . . . When discussing how their doctors were supportive, patients referred to how their providers were responsive, dependable, and provided hope and encouragement regarding benefits that could be derived from treatment. (p. 996)

Given the strong influence that HIV primary care providers appear to have with regard to HCV treatment decisions made by their patients, Osilla and colleagues surmise that the way in which providers present treatment recommendations may play a key role in the patient's response.

. . . [Approaches] can vary from one that reflects strong advocacy and encouragement of treatment, to one that is more neutral and [a] mere presentation of options, to a presentation that may subtly dissuade a patient from considering treatment. In many cases, the provider's general philosophy and sense of urgency toward treatment was reflected in [his or her] approach to presenting treatment as an option for the patient.

. . . [Among the] strategies some providers use to encourage and motivate patients to accept the [recommendation for HCV] treatment . . . [are] emphasizing the importance of treatment for the patient's health, the chance for treatment resulting in a cure, and confidence that the provider can effectively address any side effects that the patient may experience. . . . Other providers described a more neutral stance in presenting treatment as an option to the patient. These providers described an approach in which they lay out the potential benefits and costs of treatment, so that the patient can make an informed decision. Providers may be more likely to use this approach when they themselves feel ambivalent or unsure of the importance of treatment for the patient. . . . There are also providers 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 believed it was best to defer treatment and wait for better treatment to become available, and this preference can be detected in how they offer treatment to the patient. (pp. 996-997)

Osilla and colleagues conclude that

the patients in this study confirmed what had been reported by their providers, that stability of HIV disease, perceived need for HCV treatment, and treatment readiness with regard to motivation, preparedness to deal with side effects, absence of substance abuse, and stability of mental health and overall life circumstances are key factors influencing treatment decision-making. Providers play a critical role in the treatment decisions of their patients, not only by providing information and being trustworthy experts, but also through their partnership with the patient and the sequential interactions whereby both the patient and provider may influence the other's evaluation of the patient's readiness for treatment. Providers serve as key catalysts for evaluating treatment readiness, but also helping patients to address issues that impede readiness, whether through referrals, counseling, or simply ongoing support that fosters the patient's trust. (p. 998)

What Other Patients Say

Similar to Osilla and colleagues, Bova, Ogawa, and Sullivan-Bolyai (2010) set out "to describe the experiences of HIV-infected patients as they made decisions to begin or defer HCV treatment and to develop a model to guide the development of future interventions to support HCV treatment efforts in coinfected patients" (p. 65). "The study sample included 39 HIV/HCVcoinfected adults, 54% male, 51% minority, 36% without a high school diploma or GED (high school graduation equivalent), 87% with a history of mental illness, 95% with a history of substance abuse, and 59% with HCV subtype 1. The mean age of the study sample was 45.1 years (range, 34-56), and 36% had AIDS" (p. 66). Among these study participants, there were "16 in the HCV-treated cohort (who were interviewed a maximum of 3 times) and 23 in the HCV-nontreatment cohort" (p. 63).

"Analysis of qualitative data from the entire sample resulted in six major themes. These themes were further categorized into treatment barriers or treatment-facilitating factors. The two treatment barriers were (a) treatment fears (associated with side effects, liver biopsy, substance abuse relapse, and needle use) and (b) vicarious experiences. The four facilitating factors were (a) experience with illness management, (b) patient-provider relationships, (c) gaining sober time, and (d) facing treatment head-on" (pp. 66, 68). Bova and colleagues elaborate on these themes, all of which are "amenable to behavioral intervention" (p. 72), as follows:

Fears. The major concern discussed by most participants (n = 32, 82%) was fear of side effects of HCV treatment. . . . Fear of the liver biopsy was specifically mentioned by 14 (36%) participants. . . . It is also important to note that 7 participants (18%) had no major problems with the liver biopsy. . . . Many participants were aware of the potential risk of HCV treatment to their sobriety. . . . A total of 7 participants expressed concerns about the need to use needles to administer the interferon component of the HCV treatment regimen. Some were concerned about the "feeling of self-injecting," whereas others were more worried about having needles around the house. . . . (pp. 68-69)

Vicarious experiences. Many participants (n = 11) discussed seeing others going through HCV treatment or hearing the stories of others who had been treated. They said they formed their opinions about beginning treatment based on these vicarious experiences. . . . (p. 69)

Experience with illness management. Study participants (n = 7) discussed their experiences managing HIV and many other illnesses (including cancer, heart disease, diabetes, and asthma). They discussed using strategies developed over time to manage these chronic conditions as a way to manage HCV and subsequent treatment. . . . (pp. 69-70)

Patient-provider relationships. Participants also spoke about the importance of patient-provider relationships as a means to help them get through HCV treatment. They discussed the positive aspects of their relationships with various health care providers and how these relationships were integral to evaluation and treatment acceptance. . . . (p. 70)

Gaining sober time. An important concern mentioned by 6 study participants was gaining sober time. In addition, many participants discussed the role of substance use in making their treatment decisions. Participants agreed that a certain amount of sober time was needed before starting HCV treatment; the sober time mentioned ranged from 6 months to 2 years. . . . (p. 70)

Facing treatment head-on. The last theme involved facing treatment head-on. Participants described how they reframed all the negative issues associated with HCV treatment and established a mind-set that helped them move forward. (p. 70)

In discussing these findings, Bova and colleagues observe the irony that HIV-infected patients are dying from liver-related complications while having an undetectable HIV viral load. This knowledge creates a tremendous need to reduce the risk imposed by liver disease in HIV-infected patients. . . . Results of this study highlight three important issues. First, patients who accept HCV treatment differ in some way from those who refuse or defer treatment. Patients who begin treatment do reasonably well when significant supports are put in place. They tend to use strategies that help them prepare and begin treatment on the basis of earlier illness experiences. The authors' data are consistent with other reports that state that preexisting psychiatric illness was not a major barrier to HCV treatment. . . . Effective preevaluation and support strategies were in place that helped facilitate HCV treatment.

In contrast, those who do not begin treatment tend to be fearful and use other patients' negative experiences as a reason to hold off on HCV treatment. (p. 71)

From Theory to Practice

Bova and colleagues (2010) believe that these findings

shed light on possible theoretical orientations that might be useful for developing HCV-treatment interventions. For example, the result that participants used vicarious experiences to make decisions about moving forward with HCV treatment implies that Bandura's social learning theory (Bandura, 1986) might be useful for intervention development. Bandura . . . indicated that different types of information could influence a person's self-efficacy to perform certain behaviors (e.g., deciding to be treated for HCV infection). Vicarious experience is a form of learning that occurs when patients watch those similar to themselves take part in a certain behavior or activity. If HIV-infected patients have the opportunity to watch others master HCV treatment, they may be more likely to decide to move forward with HCV treatment. Likewise, an appraisal-centered theoretical orientation may be useful for intervention development. The cognitive appraisal model, for example . . . (Lazarus & Folkman, 1984)[,] focuses on the appraisal or meaning of an event (i.e., HCV infection) to one's personal well-being. An intervention that helps patients reframe the negative meaning associated with HCV treatment may be useful for helping them make HCV treatment decisions. Other models that focus on the evaluation of perceived risks and benefits (e.g., health belief model, self-regulation) may also be useful for guiding HCV intervention development. (pp. 71-72)

To conclude their discussion, Bova and colleagues reference an ethical consideration about treatment for patients living with HCV in a letter written by Rifai (2006), who "suggested that for patients to make a truly informed treatment decision, primary care providers, specialty care providers (e.g., hepatology, psychiatry), patients, and their families need to engage in a dynamic dialogue. . . . The authors concur and believe that interventions with the best chance of success in helping coinfected patients make this complicated treatment decision will be theoretically based, intense enough, and will include interprofessional involvement" (p. 72).

----Compiled by Abraham Feingold, Psy.D.


Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ: Prentice-Hall.

Bova, C., Ogawa, L.F., & Sullivan-Bolyai, S. (2010). Hepatitis C treatment experiences and decision making among patients living with HIV infection. Journal of the Association of Nurses in AIDS Care, 21(1), 63-74. Lazarus, R.S., & Folkman, S. (1984). Stress, appraisal and coping. New York: Springer.

Osilla, K.C., Ryan, G., Bhatti, L., Goetz, M., Witt, M., & Wagner, G. (2009). Factors that influence an HIV coinfected patient's decision to start hepatitis C treatment. AIDS Patient Care & STDs, 23(12), 993-999.

Rifai, M.A. (2006). Ethical impasses in the care of patients with hepatitis C [Letter]. Psychosomatics, 47(6), 540-541.

Wagner, G., Ryan, G., Osilla, K.C., Bhatti, L., Goetz, M., & Witt, M. (2009). Treat early or wait and monitor? A qualitative analysis of provider hepatitis C virus treatment decision-making in the context of HIV coinfection. AIDS Patient Care & STDs, 23(9), 715-725.
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Blood Transfusion Leads to 8 Children with HIV+, in Jodhpur

Submitted by Jason Ramsey on Mon, 07/12/2010 - 14:38

Declaring eight children as HIV positive in Jodhpur, Rajasthan, the medical reports have detected them as suffering from Thalassemia. It was reported that they had been subjected to transfusion of contaminated blood.

Plus, this blood transfusion in the city has led to 43 more kids being diagnosed with Hepatitis C. It was at the Ummed Hospital in Jodhpur, that 51 patients had got infected because of the blood transfusion that took place. This was revealed in a study conducted by the Thalassemia Society.

However, the blame has been put by the authorities on the lack of critical medical facilities that did not succeed in spotting the infected strains in the blood. The lab tests that have caused these ailments were conducted on 28 December, 2008.

Secretary Vipin Gupta said, “The blood that is being transfused into the children may contain HIV strains. This is why when the blood tests were conducted on December 28, 2008, only five cases of HIV positive and 29 cases of Hepatitis C were identified among the kids. When the tests were conducted again, in May, by the SN Medical College, the numbers increased from five to eight HIV positive cases and from 28 to 46 Hepatitis C cases”.


Thalassaemic kids in a bloody mess

Ajay Parmar, TNN, Jul 12, 2010, 04.34am IST

JODHPUR: For the children in Jodhpur, who are suffering from thalassaemia, things could not get worse.

Courtesy apathy and neglect of the authorities, these kids are allegedly subjected to infected blood. There are reports of HIV positive and hepatitis C cases pouring in everyday.

After five HIV positive cases were reported in December 2008 from here, three more kids were reported infected on May 8 after their blood samples were tested at the microbiology laboratory of the S N Medical College.

The Marwar Thalassaemia Society has issued memos to the principal of the S N Medical College demanding the setting up of nucleic acid test (NAT) technique and an updated thalassaemia ward. Earlier, the state government had constituted a committee headed by the director of the State AIDS Control Society R N D Purohit, who in his report, had suggested the need of adopting more advanced technique of blood donation but no action was taken. The secretary of the society, Vipin Gupta, said the recent cases could have been avoided if the report was taken seriously.

However, the principal of S N Medical College R K Aseri said the proposal to set up NAT technique has already been sent to the state government. But no action has been taken. Aseri, however, ruled out any method to ensure zero window period, which is the time taken for seroconversion after exposure to the HIV virus. Seroconversion is the development of detectable antibodies in the blood directed against an infectious agent. It normally takes some time for antibodies to develop after the initial exposure to the agent.

Following seroconversion, a person tests positive in tests based on the presence of antibodies.

According to Gupta, the present technique used in testing blood during donation is enzyme-linked immunosorbent assay (ELISA).

"When we've the NAT technology, which has a window period of three to seven days, why allow children to be infected with HIV and HCV," he asked.

But former associate professor (pathology), N M Mehta, said, "When we cannot do away with the window period, why not to be more cautious while drawing blood from the donor by adhering to the blood donation protocol, in which the entire history of the donor is tested." He said the donor with suspicious credentials like a drug addict, alcoholic or frequent visitor to redlight areas should be avoided. Regarding the NAT technology, Mehta said this technique requires fully trained staff, which is hardly available.

Though, Gupta claimed that all those infected had taken blood from the Umaid Hospital, Mehta said that there is a possibility of these children getting blood from some unreliable source

New ANA President Shares Her Vision

By Jennifer Thew, RN, BSN, MSJ
Monday July 12, 2010
In July 1998, the course of Karen Daley’s life, and the practice of nursing nationally, was changed forever. While disposing of a needle after drawing blood from a patient in the ED, the Massachusetts native was stuck by a needle protruding from the sharps box. A few months later, she began experiencing unexplained fatigue, weight loss and abdominal pain.

Around Christmas of that year, the source of Daley’s symptoms was discovered. She had contracted hepatitis C and HIV from the needlestick.

In 1999, the effects of the needlestick injury forced Daley, RN, PhD, MPH, FAAN, to walk away from direct-care nursing. “Because it was such a difficult course, particularly in the first few years, I didn’t know initially if I’d survive it,” Daley says of the diagnosis. “I wasn’t sure what my quality of life would be.”

Daley’s decision to leave the ED was not an easy one. “I was committed to being in direct care,” she says. “I loved direct care and I loved emergency nursing. It totally took me off what I thought was a pretty clear career path in terms of my practice.”

With the future of her health and career uncertain, Daley began to focus on advocating for needlestick safety and prevention. “The purpose I found in this work kind of kept me going,” she recalls. “And I really was committed to trying to prevent these injuries from happening to other nurses and other healthcare providers.”

Along with shifting nursing practice by helping to get the Needlestick Safety and Prevention Act passed, Daley’s passion for advocacy laid the groundwork for her to become the new president of the American Nurses Association.

In June, Daley was elected ANA president, taking the reins from outgoing president Rebecca Patton, RN.

“I became engaged in the policy arena around this issue [needlestick prevention],” Daley says. “ANA played a pivotal role in that.”

Using the resources and support of her state association, she was able to get a needlestick safety and prevention bill passed in Massachusetts. After that success, she and her fellow members galvanized ANA and state nursing organizations to advocate for needlestick prevention legislation on a national level. Through their efforts, the Federal Needlestick Safety and Prevention Act was passed Nov. 6, 2000.

Daley says her experience working with the ANA on needlestick advocacy opened her eyes to the power the organization has to make a difference. As ANA president, she says she hopes to harness that power to benefit the nursing profession.

“I think this time is a very special time for nursing, and the healthcare reform legislation creates some of the opportunities,” Daley says. “If we don’t take advantage of those opportunities, nursing is going to lose out.”

Among those opportunities, Daley says, is the chance to be involved in designing healthcare delivery models, focus on preventive care and move away from the disease-driven model of care.

“Nurses know about health and they know about health maintenance,” she says, “but we often don’t have the time within the current system, as it’s structured, to do the teaching and follow-up and to spend the time with the patients that we need to optimize their care.”

Daley sees healthcare reform as a chance to achieve milestones, such as improving patient access to primary care and advanced practice nurses, but she reminds RNs that they must be engaged in the change process to see results.

“It’s a critical time to build on the relationships Becky has fostered,” Daley says, “and I think more than any other time in the recent past, we [ANA] have a chance to bring nursing together around these issues.”

In addition to healthcare reform, Daley says the ANA will continue to address professional issues that affect nurses, such as scope and standards, ethics and policy.

She also hopes to grow membership in the ANA by educating nurses around the country on how the organization can affect nursing practice and policy.

“I feel so proud to be a part of the association,” she says. “I’ve seen up-close-and-personal how good the work is and how expert our staff is on things like policy.”

Daley stresses that ANA membership and professional participation is important in making changes to the profession.

“I’m hoping nurses will want to be a part of this organization in greater numbers,” she says, “because the reality of it is we need resources to do the work. We need members to bring what they know in terms of their experience in practice.”

Jennifer Thew, RN, BSN, MSJ, is national nurse editor.


Radiology: Perfusion CT may aid in liver disease staging

Perfusion CT scans of a 53-year-old man with minimal fibrosis
show ROIs in the aorta, portal vein and liver.
Image Source: Radiology

Perfusion CT may help discriminate between minimal and intermediate stages of fibrosis in patients with chronic liver disease, according to a study in the July issue of Radiology.

Maxime Ronot, MD, from the unit for training and research in medicine at Université Paris in Paris, and colleagues sought to prospectively assess the utility of perfusion CT for differentiating minimal from intermediate fibrosis in treatment-naïve patients with chronic hepatitis C virus infection.

For the study, 52 patients with treatment-naïve HCV infection underwent perfusion CT and percutaneous liver biopsy on the same day. The researchers measured portal vein, arterial and total liver perfusion; mean transit time; and distribution volumes for the right and left liver lobes. Liver samples were scored for fibrosis, and fibrosis area was determined. They then tested the differences in quantitative perfusion parameters between patients with minimal fibrosis (score of F1) and those with intermediate fibrosis (score of F2 or F3).

In patients with intermediate fibrosis (F2 and F3) compared with those with minimal fibrosis (F1), the portal venous perfusion (87 mL vs. 138 mL) and total liver perfusion (107 mL vs. 169 mL) were significantly decreased, and the mean transit time was significantly increased (16 seconds vs. 13 seconds), according to Ronot and colleagues.

At multivariate analysis, the researchers wrote that only the mean transit time was an independent factor. Receiver operating characteristic curve analysis showed that a mean transit time threshold of 13.4 seconds allowed discrimination between minimal and intermediate fibrosis with a sensitivity of 71 percent and a specificity of 65 percent.

Based on the study, the investigators found that perfusion changes occur early during fibrosis in chronic hepatitis C virus infection and can be detected with perfusion CT.

Ronot and colleagues did not find any correlations between fibrosis stage and immunohistochemical markers or between perfusion parameters and immunohistochemical markers. The researchers said they “expected to at least find a relationship between the stage of fibrosis and vascular changes.”

“Perfusion CT may help to discriminate minimal from intermediate fibrosis,” the authors wrote. “Mean transit time appears to be the most promising perfusion parameter for differentiating between fibrosis stages, although the large amount of overlap in the measured parameters limits the clinical utility of this test at present.”

Last updated on July 11, 2010 at 9:14 pm EST

Medivir Announces Phase 2b 24-week Interim Results of TMC435 in Treatment-niave Patients Chronically Infected with Genotype-1 Hepatitis C Virus

BusinessWire · Monday, Jul. 12, 2010

Potent and consistent antiviral efficacy was demonstrated at 24-week end-of-treatment and in interim SVR4 and SVR12 results. There were no clinically relevant differences between TMC435 treatment groups and placebo for adverse events.

Medivir (STO:MVIRB) announced today 24-week end-of-treatment interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naïve patients with hepatitis C virus (HCV) genotype-1 (TMC435-C205).

TMC435 is a protease inhibitor jointly developed by Medivir and Tibotec Pharmaceuticals, dosed as one pill once daily (q.d.) to treat hepatitis C virus infections (HCV).

In the PILLAR study, 75mg or 150mg TMC435 was given for either 12 weeks or 24 weeks in combination with 24 weeks of ribavirin and pegIFNalpha-2A, the current standard of care (SOC). Patients stopped all treatment at week 24 when HCV RNA levels at week 4 were < 25 log10 IU/mL detectable or undetectable and HCV RNA levels at week 12, week 16 and week 20 were < 25 log10 IU/mL undetectable. Patients who did not meet the above response-guided criteria continued with SOC until week 48. The results showed that in the TMC435 treatment groups 83% of patients were able to stop all therapy at Week 24.

Potent and consistent antiviral efficacy was demonstrated at 24-week end-of-treatment and in interim SVR4 and SVR12 rates with no major differences between TMC435 doses or length of triple therapy. 92% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels at week 4 and 92% at week 12 after cessation of treatment, i.e. SVR4 and SVR12. SVR4 and SVR12 data were available for 82% and 42% of the TMC435-treated patients respectively who had stopped all therapy before or at Week 24 and had completed the follow-up visits. Both the viral breakthrough rate (4.9%) and relapse rate (1.6%) were low in the TMC435 treatment groups.

TMC435 was generally safe and well tolerated with no relevant differences in adverse events (AEs) between placebo and TMC435 treatment groups. Most AEs were mild to moderate in severity and the discontinuation rate due to AEs was low and not different from placebo.

When looking at particular adverse events of interest, the incidence of rash, pruritis, GI side effects and anemia were similar in TMC435 groups and placebo and were generally mild to moderate in nature. Use of erythropoetin-stimulating agents (ESAs) was not allowed during the trial.

In laboratory parameters, there were no clinically relevant differences between any TMC435 groups and placebo except for mild bilirubin elevations. Significant decreases in transaminases (ALT and AST) were observed in all treatment groups.

Further safety and efficacy data will be presented at future scientific meetings later in 2010.

"We are extremely encouraged and excited by the efficacy and safety demonstrating that TMC435 is truly a second-generation HCV protease inhibitor," stated Bertil Samuelsson, CSO of Medivir. "We also are looking forward to the top-line data coming up from the phase 2b trial C206 (ASPIRE) in treatment-experienced patients later this year as well as start of phase 3 clinical trials in treatment-naïve patients early next year.”

Frequency of Undetectable* HCV RNA Levels During and After Treatment

About TMC435 clinical trial programs
TMC435 is a protease inhibitor jointly developed by Medivir and Tibotec Pharmaceuticals to treat hepatitis C virus infections (HCV).

TMC435 is currently being developed in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naïve and in G1 patients that failed previous IFN-based treatment. Safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2010.

TMC435-C205 is a global phase 2b study in 386 genotype-1 treatment-naïve patients. It is a once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.

TMC435-C215 is a Japan phase 2b study in 92 genotype-1 treatment-naïve patients. It is a once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.

TMC435-C206 is a global phase 2b study in 463 genotype-1 treatment-experienced patients. It is a once daily treatment of TMC435 in with different doses of given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.

About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.

Invitation to a Press Conference
Medivir will host a teleconference today at 15:00 (Central European summer time) focusing on the phase 2b 24-week interim results.

To participate in the teleconference, please call +46 8 619 75 30 using the participant code 195272#.

For more information on Medivir, please see the company website: http://www.medivir.se/ (http://www.medivir.se/)

This information was brought to you by Cision http://www.cisionwire.com/

Rein Piir, CFO & VP Investor Relations
Tel: +46 8 54683123 or +46 708 537 292.