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Correspondence to: Paul H Naylor, Division of Gastroenterology, 603 Hudson Building, Harper University Hospital, 3990 John R, Detroit, MI 48201, USA.
AIM: In this paper, we review the results of the addition of a direct acting antiviral (DAA) to dual therapy [Pegylated-Interferon (Peg-IFN)+Ribavirin (Riba)] therapy in African Americans (AA) treated for chronic hepatitis C (CHC) in an urban GI clinic as compared to the licensing studies.
METHODS: Patients with genotype one (G1) CHC treated with dual therapy (n=341 naive patients), were compared to G1 patients (n=75 naive or previously treated with interferon based therapy) treated with triple therapy (telaprevir or boceprevir +Peg-IFN+Riba).
CONCLUSIONS: The data confirms previous reports from the licensing trials that adding a 1st generation DAA to dual therapy in the real world clinic setting provides a significant improvement in SVR in African Americans, regardless of whether the patients are naive or treatment experienced. More than 3.2 million people in the United States (1% of the population) are chronically infected with hepatitis C virus (HCV) and thus exposed to significant risk of developing HCV related morbidity and mortality[1-6]. Sustained viral response (SVR) to interferon based therapies is associated with decreased liver related morbidity and mortality in patients with HCV infection and the development of more effective treatments is a continuing clinical goal[13,14]. Based on medical records from 1995 to 2013, complete data on 416 CHC patients (AA=341; Cau=75) who were treated with interferon based therapy was collected. As shown in table 1, the majority of patients seen in the clinic were AA (dual=81% and triple=90%). Response to therapy was evaluated for both the overall and the racial sub groups since studies have suggested that AA were less likely to respond than Cau for both dual and triple therapy[10,15,16].
Dual therapy patients were all naive to treatment whereas triple therapy was approved for treatment-experienced patients as well as naive. As shown in figure 3, triple therapy in AA patients enhanced the viral elimination rate at all stages of fibrosis when compared to AA treated with dual therapy. As predicted from the literature and the FDA approved drug inserts, triple therapy appeared to increase the incidences of anemia as defined by low hemoglobin and neutropenia and added new side effects which included pruritus, dysgeusia and anal symptoms (Table 3). This study supports previous reports from the licensing studies that adding a DAA to peg-IFN and riba (triple therapy) increases the SVR for African American patients treated in an urban clinic as compared to peg-IFN and riba (dual therapy). Since many of the patients have been infected for a considerable period of time, they have an increasing risk of advanced fibrosis, cirrhosis and hepatocellular carcinoma[3,5]. In comparing the factors that biased patients towards enhanced response, we found that viral load was more of a factor with respect to failure for dual therapy than triple therapy.
The side effect profiles for both therapies were similar to those reported for the licensing trials.
This study is important due to the demonstration in a predominately African American population in a real world clinic population, that there is significant improvement in the response of African Americans to triple therapy as compared to dual therapy. While the response rates are better for AA patients treated with triple therapy as compared to dual therapy, it remains less than 50% for the majority of patients seen in our clinics. Kinzie JL, Naylor PH, Nathani MG, Peleman RR, Ehrinpreis M N, Lybik M, Turner J R, Janisse J J, Massanari M, Mutchnick M G.
Flamm SL, Muir AJ, Fried MW, Reddy K R, Nelson D R, Bzowej N H, Sullivan J C, Bengtsson L, DeMasi R, Wright C I, Kieffer TL, George S, Adda N, Dusheiko G. Dusheiko GM, Fried MW, Reddy R, Nelson DR, Bzowej N, Adda N, Wright CI, Bengtsson L, George S, Flamm SL.
Picchio G, De Meyer S, Dierynck I, Ghys A, Gritz L, Kieffer T L, Bartels D J, Witek J, Bengtsson L, Luo D, Kauffman R S, Adda N, Sarrazin C. Sherman KE, Flamm SL, Afdhal NH, Nelson D R, Sulkowski M S, Everson G T, Fried M W, Adler M, Reesink H W, Martin M, Sankoh AJ, Adda N, Kauffman RS, George S. Peer reviewer: Hamdy Sliem, professor of internal medicine, faculty of medicine, Suez canal university, Ismailia, Egypt. Herpes Zoster, often known as shingles, is a frequently painful skin rash localized to one region of the body.
Patients with zoster are contagious and should avoid immunosuppressed people, pregnant women, and people that have not had chicken pox.
Herpes zoster ophthalmicus occurs when VZV infects the first branch of the trigeminal nerve, V1. Herpes zoster oticus (Ramsay Hunt Syndrome) describes VZV affecting the V3 branch of the trigeminal nerve.
Herpes zoster usually begins as a one-sided tingling or burning pain, which may actually become quite severe before the rash appears.
Because shingles usually resolves itself, treatment is not absolutely required, but early treatment may reduce the likelihood of long term pain.
In extreme cases, shingles may also lead to blindness (if the shingles occur in the eyes), deafness, or secondary skin infection. All material on this website is protected by copyright, Copyright © 2009-2016 by DermDiagnosis LLC. Pemphigoid gestationis, also known as herpes gestationis, is a rare skin condition which affects pregnant women.
Pemphigoid gestationis is an autoimmune condition in which the immune system attacks the membrane between the dermis and epidermis (the midle and top layer of skin).
Pemphigoid gestation is is typically diagnosed based on the characteristic appearance of the affected area.


The primary goal in treating pemphigoid gestationis is the relief of symptoms and the prevention of secondary infection.
In interferon experienced patients, the SVR for triple therapy was better in patients who had relapsed as compared to non-responders or naive patients.
While treatment with these therapies are clearly beneficial for patients with advanced disease, the lower SVR rate for AA as compared to Cau presents a challenging situation and that waiting for more effective therapies may be a prudent option for the majority of patients. Interferon (IFN) Based Treatment of African Americans with Chronic Hepatitis C (CHC) in an Urban Clinic: Improving Response with Advances in Therapy. African Americans (AA) are twice as likely to be infected with HCV compared to the non-Hispanic- white US population (Cau) and in addition, have a lower response rate to approved IFN based therapies[7-12]. The mainstay of current therapies is pegylated-IFN-alpha (peg-IFN) which is given by injection and ribavirin (riba) which is an oral medication associated with significant anemia. The age was slightly higher in the patients treated with triple therapy, consistent with either the predicted “aging” of the infected population or selection of patients with more advanced disease for treatment. Comparison between previously treated and non treated patients could thus be assessed for triple therapy.
There was no statistically significant difference between the response rate of early fibrosis (0-2) vs late fibrosis (3-4) (27% vs 15% for dual and 62% vs 52% for triple). Although the number of Cau treated with triple therapy was small, anemia (34% vs 14%) and especially pruritus (60% vs 14%) appeared to be more prominent in AA than Cau. One reason these studies are important is that clinical trials often do not include large numbers of AA since they represent only 13% of the population.
Treating these patients with advanced fibrosis is critical, but responses were poor for dual therapy.
AA had lower responses for both therapies compared to Cau, and, in multivariate analysis, race was a factor in both dual and triple therapy. DAA addition enhanced the anemia know to be due to ribavirin and added the additional side effects of pruritus, dysgeusia and anal symptoms. A weakness in this study is that the clinic population is predominately African American and since few Caucasians are seen in the clinic, there were significantly fewer Caucasians in the triple therapy group as compared to the dual therapy group. Consistent with the observation that licensing trials may not predict the response of a difficult to treat minority population, this response is lower than predicted based on the small number of AA in the licensing trials. Global burden of hepatitis C: considerations for healthcare providers in the United States.
The hidden epidemic of hepatitis C virus infection in the United States: occult transmission and burden of disease. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Increasing prevalence of HCC and cirrhosis in patients with chronic hepatitis C virus infection.
African Americans with genotype 1 treated with interferon for chronic hepatitis C have a lower end of treatment response than Caucasians. Optimum Ribavirin Exposure Overcomes Racial Disparity in Efficacy of Peginterferon and Ribavirin Treatment for Hepatitis C Genotype 1.
Sustained Virologic Response Rates With Telaprevir-Based Therapy in Treatment-Naive Patients Evaluated by Race or Ethnicity. All-Cause Mortality and Liver-Related Outcomes Following Successful Antiviral Treatment for Chronic Hepatitis C.
A sustained viral response is associated with reduced liver-related morbidity and mortality in patients with hepatitis C virus. Interpreting discordant indirect and multiple treatment comparison meta-analyses: an evaluation of direct acting antivirals for chronic hepatitis C infection.
Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin Increased Sustained Virologic Response Rates in Treatment-Naive Patients Regardless of Race or Ethnicity. Melanoma is the leading cause of cancer death of women in their 20s and second only behind breast cancer among women in their 30s? When this occurs on the left side of the chest, it is sometimes mistaken for a heart attack. A skin biopsy will be performed to confirm the diagnosis and to rule out similar appearing conditions.
Topical corticosteroids are typically used to treat moderate cases, while systemic corticosteroids may be required in more severe cases. I have tried to use anti itch sprays and creams that say they help with dermatitis yet nothing helps.
Studies focusing on this population provide useful information with respect to the efficacy of new therapies and decisions to treat this historically low response rate group. Over the past three years, addition of direct acting antivirals (telaprevir and boceprevir) has enhanced the response rates, but the medications also increased the anemia associated with IFN and ribavirin and, brought additional side effects including dysgeusia, severe rash and anal symptoms[15-19]. The majority of patients (AA= 275 Cau=68) were treated with dual therapy (Peg-IFN+Ribavirin) while the more recent patients (AA=68 and Cau=7) were treated with triple therapy (telaprevir or boceprevir with Peg-IFN+Rib).
Body weight was similar and using current definitions, the majority was in the overweight to obese category.


Despite the challenges of increased side effects, patients in the triple therapy were less likely to discontinue than those in dual therapy (26% vs 17%). For example, pooling of the patients treated in phase 3 studies with telaprevir in combination with pegylated interferon alpha (peg-IFN) and ribavirin (riba) as compared to dual therapy (peg-IFN+riba) was required in order to generate sufficient number of AA for comparison (127 AA and 1,124 Cau)[11,12,18-20]. With respect to race, AA had higher rates of pruritus (65%) than Cau (14%) but the number of Cau in our study was low. Thus it is imperative that the AA population, many of whom have advanced liver disease, be afforded rapid access to the next generation therapies. Once an outbreak of chicken pox has resolved, the virus becomes dormant in the sensory nerve root along the spinal cord. However, the older the patient, the more severe the outbreak and the longer the delay in therapy, all increase the risk of post herpetic neuralgia. In the majority of cases, the condition resolves within a few days after giving birth, though flare-ups often occur around the time of delivery. Her hair on her backside falls out (included picture)and she gets bad sores around her head and neck. Despite the increase in side effects seen in patients with the addition of DAA, discontinuation rates were fewer for triple than for dual therapy. Such studies are of importance since many clinical trials overestimate the response of AA patients treated in community settings.
This study focuses on African Americans and compares the SVR, side effects and discontinuation rates seen with dual therapy (peg-IFN+ribavirin) vs first generation DAAs (telaprevir and boceprevir) given with triple therapy (peg-IFN+riba).
The objective of this IRB approved study was to compare the responses in patients treated with dual therapy to those given triple therapy.
The responses reported in the study for AA with triple therapy was higher than for dual therapy [(62% (n=99) vs 29% (n=28)].
While significant numbers of patients did experience side effects, they were generally mild and medically manageable.
These therapies will predictably increase the SVR in this previously difficult to treat group.
Once the blisters break, ulcers dry out and form crusts, which normally fall off in two to three weeks.
Other than the flea prevention meds and the anti itch meds I am at a loss on how to help her. The study presents data from both AA and Cau patients with chronic hepatitis C (CHC) who were seen in an urban clinic environment.
All patients included in this study were genotype 1 and received at least 1 treatment with interferon based therapy. In Cau the responses were also greater for triple vs dual therapy but were also greater than for AA [78% (n=791) vs 47% (n=333)]. This was especially true for the anemia which in triple therapy could be handled by reducing the ribivarin without having a negative impact on the impressive improvement in response compared to dual therapy. The rash usually occurs anywhere from the spine to the front of the belly, though it can involve the face, mouth, eyes, or ears.
In rare cases, complications such as premature delivery, temporary transient blisters affecting the infant, and secondary infection may occur as a result of the condition. In patients who had liver biopsy, fibrosis scores were also similar between the two treated groups although in the triple therapy groups, many of the biopsies were performed more than 2 years prior to initiating treatment. Thus while triple therapy was better than dual therapy for both races, the overall response rate for dual and triple therapy is biased by the large numbers of higher responding Caucasians and therefore misleading with respect to the response of individual African Americans. Although there were considerably more side effects associated with the triple therapy, discontinuation rates were lower. Additional symptoms may include abdominal pain, chills, fever, joint pain, taste and vision problems, headaches or even loss of eye motion or a drooping eye. I was told by the vet to put a cone on her but I think that is kind of cruel, have you ever had an itch you could'nt scratch?
Thus, the data in our study demonstrates that even in the harder to treat population (AA with genotype 1) who are the predominant population seen in our clinic, the overall protocol response rates of 51% vs 24% was a significant improvement in SVR. Whether this represents better management, greater incentive to continue due to the fast decline of viral load in the majority of patients or other factors is not known. Forehead or eyelid involvement especially with nasal tip blisters warrants immediate therapy and evaluation by ophthalmology. For patients on dual therapy SVR was defined as a non-detectable HCV RNA 6 months after EOT.
In the hardest to treat population, treatment experienced non-responding AA with genotype 1, the response rate was still 46%.



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