September 15, 2013

FDA blows alarm on fake Hepatitis B herbal medicine

Health News of Monday, 9 September 2013

The Food and Drugs Authority (FDA) has raised alarm on the distribution and sale of a fake herbal medicine called HEPTA 3.

According to the FDA, it has not registered HEPTA 3 as claimed by the manufacturer.
The manufacturers of HEPTA 3, Dr. Akosua Adu-Ayaa and Akomea Sakyi, who operate a herbal clinic/manufacturing facility at Chirapatre in Kumasi, called Power Specialist Clinic / Power Health Products Limited. HEPTA 3 is supposed to treat Hepatitis B, Typhoid fever and other immune-compromised conditions.

Meanwhile, Dr. Akosua Adu-Ayaa and Akomea Sakyi, manufacturers and distributors of HEPTA 3, have been arrested by the police in Kumasi.

A press statement signed by Dr. Stephen K. Opuni, Chief Executive Officer (CEO) of the FDA, advised the general public not to patronize HEPTA 3, because it cannot treat Hepatitis B infection.

Moreover, Hepatitis B infection is a viral disease whilst Typhoid fever is caused by salmonella bacteria. One product cannot, therefore, treat the two disease conditions.

Dr. Opuni’s statement explained that Hepatitis B infection can lead to life-threatening complications, like impairment of the liver (reduced ability of the liver to function), liver failure and an increased risk of developing liver cancer. Hepatitis B infection can also cause kidney problems that may lead eventually to kidney failure.

In view of the seriousness of the above complications, it is unacceptable for anyone to mislead the public that he/she has a cure for Hepatitis B, when actually that is not true.

The FDA entreated the public to report anyone found selling HEPTA 3 to the nearest FDA office or the Police.

Additionally, information from the general public on persons in any practice possible of endangering public health and safety with respect to FDA’s mandate is most welcomed, through any of the following contact numbers; 0244337235, 0544338829, 0246809509 or 0544863418.


Cheat Sheet for ABBV/ENTA Phase-3 HCV Program

Provided by Investors Hub

Saturday, September 14, 2013 9:47:22 PM


Re: DewDiligence post# 164591

ABBV/ENTA have 9 global phase-3 trials testing an all-oral regimen in HCV genotype-1a/1b : 6 trials that comprise the initial NDA/MAA submissions in 2Q14, and 3 trials for subsequent use.
(MALACHITE-1 and MALACHITE-2 are essentially phase-4 trials
that have been listed as phase-3.)

All 9 of these global phase-3 trials include the 3-DAA combination of the protease inhibitor, ABT-450/r (licensed by ABBV from ENTA); the NS5A inhibitor, ABT-267 (from ABBV’s pipeline); and the non-nucleoside polymerase inhibitor, ABT-333 (from ABBV’s pipeline).  Some of these trials also include ribavirin in one or both trial arms. SAPHIRE-1 and SAPHIRE-2 are essentially safety studies, as explained in #msg-91739317.

(ABBV/ENTA are testing the 2-DAA regimen of ABT-450/r + ABT-267 in a phase-3 trial for genotype-1b patients in Japan [#msg-91870291] and in various phase-2 trials globally.)

Six phase-3 trials comprising initial NDA/MAA submissions:

SAPPHIRE-1—(see #msg-91739317 for discussion)—treatment-naïve GT1a/1b w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w vs. identical regimen delayed by 12 weeks of placebo use; 600 patients; expected completion Sep 2013:

SAPPHIRE-2—(see #msg-91739317 for discussion)—treatment-experienced GT1a/1b w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w vs. identical regimen delayed by 12 weeks of placebo use; 400 patients; expected completion Sep 2013:

PEARL-2—treatment-experienced GT1b w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 ± ribavirin for 12w; 210 patients; expected completion Mar 2014:

PEARL-3—treatment-naïve GT1b w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 ±ribavirin for 12w; 400 patients; expected completion Dec 2013:

PEARL-4—treatment-naïve GT1a w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 ±ribavirin for 12w; 300 patients; expected completion Dec 2013:

TURQUOISE-2—DAA-naïve GT1a/1b with cirrhosis; ABT-450/r + ABT-267 + ABT333 + ribavirin for 12w vs. identical regimen for 24w; 380 patients; expected completion Dec 2013:

Three phase-3 trials not part of initial NDA/MAA submissions:

TURQUOSE-1—DAA-naïve GT1a/1b with HIV co-infection; ABT-450/r + ABT-267 + ABT333 + ribavirin for 12w vs. identical regimen for 24w; 300 patients; expected completion Dec 2014:

MALACHITE-1—5-arm trial including 3 DAA arms and 2 control arms—treatment-naïve GT1a/1b; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w vs. Incivek + peg-IFN + ribavirin for 12w plus an additional 12w or 36w of peg-IFN/ribavirin on a response-guided basis; separate DAA and control arms for GT1a and GT1b; additional DAA arm for GT1b without ribavirin; 314 patients; expected completion Jul 2015:
(Note: This is essentially a phase-4 trial.)

MALACHITE-2—treatment-experienced GT1a/1b; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w: vs. Incivek + peg-IFN + ribavirin for 12w plus an additional 12w or 36w of peg-IFN/ribavirin on a response-guided basis; 150 patients; expected completion Jul 2015:
(Note: This is essentially a phase-4 trial.)


Is 3 the new 1: perspectives on virology, natural history and treatment for hepatitis C genotype 3

Journal of Viral Hepatitis

Volume 20, Issue 10, pages 669–677, October 2013


E. B. Tapper1,2, N. H. Afdhal2,3,*

Article first published online: 8 SEP 2013

DOI: 10.1111/jvh.12168

© 2013 John Wiley & Sons Ltd


Keywords: alisporivir; cirrhosis; hepatic steatosis; interferon; ribavirin; sofosbuvir


Affecting 2–3% of the world's population, hepatitis C is a common viral infection which is a significant cause of morbidity and mortality. Hepatitis C genotype 1 is the dominant viral genotype among Western patients. For the last 20 years, in the era of interferon-based therapy, it was far more difficult to treat relative to genotypes 2 and 3. Accordingly, a significant focus of research was on new antiviral agents for the dominant genotype 1 patient. Now, as promising specific treatments are being introduced for genotype 1, the attention of clinicians and researchers has turned back to the 50–70 million patients infected with a nongenotype 1 hepatitis C. Furthermore, after recent, larger randomized trials, we have realized that genotype 2 is truly interferon sensitive while genotype 3 patients are far less successful with therapy. In this fundamentally altered landscape, genotype 3 is now potentially the most difficult to treat genotype and an area of intense research for new drug development. Herein we review the virology, natural history and the treatment of genotype 3 hepatitis C.


All-oral therapy with nucleotide inhibitors sofosbuvir and GS-0938 for 14 days in treatment-naive genotype 1 hepatitis C (NUCLEAR)

Journal of Viral Hepatitis

Volume 20, Issue 10, pages 699–707, October 2013

Original Article

E. J. Lawitz1,*, M. Rodriguez-Torres2, J. Denning3, A. Mathias3, H. Mo3, B. Gao3, M. T. Cornpropst4, M. M. Berrey5, W. T. Symonds3

Article first published online: 31 MAR 2013

DOI: 10.1111/jvh.12091

© 2013 Blackwell Publishing Ltd


Keywords: antiviral agents; direct-acting antiviral agents; nucleotide analogue; viral drug resistance


Sofosbuvir and GS-0938 are distinct nucleotide analogues with activity against hepatitis C virus (HCV) in vitro. We evaluated the antiviral activity and safety of sofosbuvir and GS-0938 alone and in combination in HCV genotype 1 patients. In this double-blind study, 40 treatment-naïve patients were randomly assigned to 4 treatment cohorts: (i) GS-0938 for 14 days, (ii) GS-0938 for 7 days followed by GS-0938 plus sofosbuvir for 7 days, (iii) sofosbuvir for 7 days followed by GS-0938 plus sofosbuvir for 7 days and (iv) GS-0938 plus sofosbuvir for 14 days. In each arm, 8 patients received active drug and 2 placebo. After 7 days of dosing, patients in all 4 dose groups experienced substantial reductions in HCV RNA, with median declines (Q1, Q3) of −4.50 (−4.66, −4.24) in Cohort 1, −4.55 (−4.97, −4.13) in Cohort 2, −4.65 (−4.78, −4.17) in Cohort 3 and −4.43 (−4.81, −4.13) in Cohort 4; patients receiving placebo had essentially no change in HCV RNA (+0.07 log10 IU/mL). Seven days after the end of treatment, the proportions of patients with HCV RNA <15 IU/mL were 4 (50%), 8 (100%), 7 (88%) and 5 (63%) for Cohorts 1–4, respectively, vs 0 for placebo. No viral breakthrough or resistance mutations were observed. No serious adverse events or Grade 3 or 4 adverse events were reported. Sofosbuvir and GS-0938—alone and in combination—were well tolerated and led to substantial reductions in viral load. Sofosbuvir is undergoing further investigation as a possible backbone of an all-oral regimen for chronic HCV.


Knowledge and attitudes about hepatitis C virus (HCV) infection and its treatment in HCV mono-infected and HCV/HIV co-infected adults

Journal of Viral Hepatitis

Volume 20, Issue 10, pages 708–714, October 2013

Original Article

E. Y. Chen1, C. S. North2, O. Fatunde3, I. Bernstein4, S. Salari3, B. Day3, M. K. Jain1,3,*

Article first published online: 1 APR 2013

DOI: 10.1111/jvh.12095

© 2013 Blackwell Publishing Ltd


Keywords: attitude; health beliefs; hepatitis C virus; human immunodeficiency virus; intervention research; knowledge


Hepatitis C virus (HCV) treatment is rapidly changing but little is known about patients' attitudes and knowledge about HCV. This study used a cross-sectional survey to examine the relationship between HCV knowledge and attitudes towards HCV in patients with HCV mono-infection and HIV/HCV co-infection. Subsequently, an education intervention was developed with an abridged version of the cross-sectional survey administered before and after the education session to assess changes in knowledge and attitudes. 292 people participated in the cross-sectional survey, and 87 people participated in the education intervention. In the cross-sectional survey, the mean knowledge score regarding HCV was low (<50% of the total possible score). Mono-infected and co-infected individuals shared similar knowledge deficits and attitudes towards HCV despite having distinct demographic differences. Attitudes endorsed by patients included the following: 57% feared the consequences of HCV on their life, 37% felt HCV was not fatal, 27% did not believe they needed HCV medication, 21% felt ashamed of having HCV and 16% felt HCV treatment was not important. Attitudes that reflected indifference and shame towards HCV were associated with lower knowledge scores (HCV knowledge score of 15.1 vs. 17.5, P < 0.01 for indifference and 15.3 vs. 17.2 for shame, P = 0.02). The education intervention improved knowledge scores but did not modify the assessed attitudes. Intervention studies are needed to effectively change attitudes towards HCV infection and treatment.


Single HIV Pill More Likely to Foster Adherence

Published: Sep 14, 2013

By Cole Petrochko, Staff Writer, MedPage Today

Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania

Action Points

  • This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
  • This observational study demonstrated increased adherence and decreased hospitalizations among veterans taking a "combination" HIV pill compared to those taking multiple pills.
  • Be aware that significant baseline differences existed between these groups, including the fact that the single-pill group was more likely to be treatment-naïve.

DENVER -- Veterans receiving highly active antiretroviral therapy (HAART) were more likely to adhere to treatment and less likely to be hospitalized when taking a single versus multiple tablets, researchers reported here.

Compared with veterans with a multiple-pill treatment burden, single-pill therapy was associated with a nearly two-fold odds of adherence (odds ratio 1.98, P<0.001) and a 31% lower risk of hospitalization (hazard ratio 0.69, P<0.001) at follow-up, according to Scott Sutton, PharmD, of the Dorn Veterans Affairs Medical Center in Columbia, S.C., and colleagues.

Among hospitalizations, single-pill therapy was associated with "a reduced risk of hospitalizations, fewer hospitalizations, and a longer time to hospitalization," Sutton said during an oral session at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

Past research has shown that patients taking single-pill multidrugs were as likely as those taking multipill regimens to switch therapies, though single-pill therapy with the combination efavirenz, tenofovir, and emtricitabine (Atripla) had better odds of controlling HIV, according to data presented at the AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention July 2013.

Sutton noted that other research has shown that once-daily dosing regimens are preferred by patients and that commercial and Medicaid patient populations receiving single- versus multidrug therapy saw a 24% and 25% respective reduction in risk of hospitalization.

The authors studied the impact of a single-tablet regimen on adherence to HAART versus a multi-tablet regimen, as well as risk and frequency of hospitalization, and differences in viral load between the two treatment groups. The study population consisted of 15,602 veterans (6,191 in the single-ill group and 9,411 in the multi-pill group) receiving care through the VA healthcare system.

Participants received a diagnosis or had past medical history of HIV/AIDS and received a HAART regimen over the course of the study, which contained two nucleoside/nucleotide reverse transcriptase inhibitors and a third agent from another drug class, including non-nucleoside/nucleotide reverse transcriptase inhibitor, protease inhibitor, another nucleoside/nucleotide reverse transcriptase inhibitor, chemokine receptor 5 antagonist, or integrase inhibitor.

Those in the single-tablet group received a complete HAART regimen of a single pill daily over the study period, regardless of prior or subsequent use of different regimens, while those in the multi-pill group received two or more tablets daily and did not receive a regimen of a single tablet daily over the study period.

Participants were followed-up one or more times in the clinic and one or more times in the laboratory 6 months before the index day and had a minimum of 60 days of follow-up after the enrollment date.

Pharmacy fill dates were used to determine adherence to treatment. Additionally, authors recorded data on hospitalizations and whether or not participants had an undetectable viral load.

Mean patient age was 51.6 in the single-tablet group and 52.4 in the multi-tablet group. Each sample was predominantly male (97% versus 98%) and most had a mental health disorder (64% versus 66.5%). Participants were mostly black (49.3% versus 45.4%) or white (40.4% versus 43.7%) and nearly 40% of each group had a drug or alcohol abuse disorder (38.6% versus 39.7%).

More patients in the single-pill group were treatment-naïve(27.5% versus 12.7%), and slightly fewer had an undetectable viral load during the pre-index period (42.1% versus 46.3%). Mean CD4 cell counts were 432.2 cells/mm3 versus 419.3 cells/mm3.

At adherence thresholds of 80% and 95%, those in the single-pill group were significantly more likely to adhere to their treatment regimen. They were also less likely to be hospitalized and the average number of hospitalizations was significantly lower among patients with one or more hospitalizations who had received one pill daily (2.2 versus 2.7, P<0.001).

The proportion of patients with an undetectable viral load from index date to follow also varied significantly at both dates, favoring those in the multi-drug group (P<0.001) at the index date, and the single-drug group at follow-up (63.9% versus 59.6%, P<0.001).

Session co-moderator Joseph Eron Jr., MD, of the University of North Carolina in Chapel Hill, was not sure if the data were conclusive. He noted that adherence from VA patients was extremely high.

"I think if they actually show...when you control for adherence, that the hospitalizations come together, that would impress me," he told MedPage Today, adding that "when they control for adherence [and] there's still a difference between the two groups, then I would worry that there's some channeling bias we're not measuring."

Sutton noted that their study was limited by generalizability, adherence measurements based on pharmacy records, and variance of reporting between clinicians and sites.

The study was supported by Gilead Sciences and the authors received support from the company.

Primary source: ICAAC
Source reference: Stutton SS, et al. "Impact of highly active antiretroviral therapy regimen on adherence and risk of hospitalization in veterans with HIV/AIDS" ICAAC 2013;abstract H-1464.


Signature Campaign on Hep-C begins

Our Correspondent Kohima | September 14

‘Be informed about the disease, go for counseling, avail treatment and monitor your steps’

“Hepatitis-C is curable. People are dying of a curable disease,” lamented Abou Mere, President Indian Drugs Users Forum (IDUF), while declaring open the sixty days Signature Campaign today on Hepatitis-C organized by the Kohima Users’ Network (KUN) in collaboration with Hepatitis Coalition of Nagaland (HepCoN) at the KUN office at Red Cross Complex here. The signature campaign also aims to provide hard facts about Hep-C to the masses, especially to People who Use Drugs (PUDs) through group sessions and one-to-one interactions.

“There is very less or no awareness of Hep-C in Naga society. Through the society’s support, the sixty days signature campaign will surely bring changes in our society,” said Kevinguto Khamo, President, KUN. The inauguration program was chaired by Ketho Angami while the methodology of the campaign was highlighted by Ato, Joint Secretary KUN.

Dr. Dietho Koza, Medical Officer, Kripa Foundation, while speaking on ‘What is Viral Hepatitis,’ emphasized on the six types of Hepatitis virus, i.e., A, B, C, D, E and G. These viruses get transmitted fecally, through lack of hygiene, transfusion of blood, contamination of food, sharing of needles and syringes and even raw salads. Alcoholics have higher chances of developing the Hepatitis-C. “The silver lining is that the Hep-C virus clears itself in 40 percent of cases. In the long run, the disease can lead to liver cancer. So get information about the disease, go for counseling, avail treatment and monitor your steps,” said Dr. Dietho. He further hoped that the campaign will pave way in the future for the availability of free treatment for Hep-C.

A short testimony was also given by Nikhil, member of KUN, who shared about his lack of awareness during the initial stage of being infected with Hep-C.
“Drug users have often being looked down on and treated as useless by the society. But we have become productive today,” said Abou Mere who also emphasized on the need to further advocate on Hep-C. Citing the Constitution on the Right to Health, Mere also said that the government has not been responsible because it has patented drugs which further leaves the poor people untreated due to the skyrocketing prices of medicines.

The campaign focuses to educate PUDs by reaching out to them at the various Injecting Drug Users (IDU) intervention projects of Nagaland SACS. The campaign has been divided into 3 teams to reach out to eight sites in Kohima. A team will focus on the main town (Razhü Point), P R Hill, Tinpati and High School areas, another on the southern part that is Jakhama and Viswema areas and the other on the extreme north that is Tseminyu and Chunlikha block.

Recent data from the Department of Microbiology Naga Hospital Authority Kohima (NHAK) shows that the prevalence rate of Hep-C stands at 1.8 percent from 2006-2012 which is an alarming indication and a concern to the whole society.