January 3, 2011

By: DENISE NAPOLI, Internal Medicine News Digital Network

01/03/11

Although percutaneous radiofrequency ablation and surgical resection for small hepatocellular carcinomas have similar survival rates, ablation patients have a higher rate of cancer recurrence, compared with surgical resection patients, reported Dr. Hung-Hsu Hung and colleagues in the January issue of Clinical Gastroenterology and Hepatology.

Dr. Hung, of Taipei (Taiwan) Veterans General Hospital and the National Yang-Ming University, also in Taipei, looked at 419 consecutive patients who underwent radiofrequency ablation (RFA) or surgical resection (SR) at the hospital in 2002-2007. All patients had no more than three small (5 cm or less) liver tumors without extrahepatic metastasis (Clin. Gastroenterol. Hepatol. 2011 January [doi:10.1016/j.cgh.2010.08.018]).

In all, 190 patients underwent RFA and the remaining 229 underwent SR to treat their liver cancer. Patients who chose SR were on average slightly younger (60 years vs. 67 years; P less than .001). This was expected, given the invasive nature of the surgery.

Additionally, the authors found that there was a higher proportion of patients with chronic hepatitis B in the SR group than in the RFA group (59.8% vs. 46.3%; P = .004), whereas chronic hepatitis C was more common in the RFA group (44.7% vs. 26.6%; P less than .001).

This was also an expected finding, because in chronic HBV infection, hepatocellular carcinomas tend to occur at a younger age, the researchers wrote.

Regarding survival, 83 patients had died after a median follow-up of more than 42 months. "Among the 190 patients [who] underwent RFA, 41 (21.6%) died during the follow-up period; 97 (51.1%) were alive with regular visits" until Jan. 31, 2010, and the remaining 52 (27.4%) were lost to follow-up sometime before 2010.

In comparison, there were 42 deaths (18.3%) among the SR group, with 120 patients known to be alive through Jan. 31, 2010 (52.4%), and the remaining 67 patients (29.3%) lost to follow-up.

"The cumulative overall survival rates at 1, 2, 3, and 5 years were 97.3%, 92.2%, 88.2%, and 79.3% in the SR group and 96.6%, 86.7%, 77.3%, and 67.4% in the RFA group, respectively," a significant difference in univariate analysis (P less than 0.009), wrote the authors.

However, after controlling for the older age and comorbidities of the RFA group in multivariate analysis, the authors found that RFA was not an independent risk factor associated with poor survival.

Next, the authors looked at factors associated with cancer recurrence. Overall, 244 patients had experienced tumor recurrence at a median of 14.5 months following RFA or SR.

"The cumulative recurrence rates at 1, 2, 3, and 5 years were 17.4%, 30.5%, 43.9%, and 59.1% in the SR group and 37.4%, 54.1%, 71.0%, and 79.5% in the RFA group, respectively (P less than .001)," they reported.

As with survival, that translated to a significantly higher univariate risk of recurrence among RFA patients (hazard ratio, 2.05; 95% confidence interval, 1.58-2.65). When assessed in a multivariate analysis, RFA was still significantly associated with cancer recurrence (HR, 1.95; 95% CI, 1.48-2.57; P less than .001).

The finding of equal survival but greater recurrence among RFA patients persisted in a third propensity analysis, which employed nearest-neighbor one-to-one matching of 84 patients in each group in terms of age, sex, tumor size, tumor number, platelet counts, hepatitis status, and several other parameters.

The only subgroup for which RFA was equal to SR in terms of both survival and tumor recurrence was patients with solitary hepatocellular carcinoma less than 2 cm in size, known as "very early small HCC (Barcelona Clinic Liver Cancer stage 0)" tumors.

According to the authors, their study "highlights the importance of close surveillance after local ablation therapy." Additionally, the authors concluded that RFA may be a good alternative to surgical resection for BCLC stage 0 HCC, although prospective study is needed.

Dr. Hung and colleagues disclosed no conflicts of interest related to this study.

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The CDC HIV/Hepatitis/STD/TB Prevention News Update

Beacon NewsFlashes – January 3, 2011 (The AIDS Beacon)

By Courtney McQueen
Published: Jan 3, 2011 3:05 pm

ViiV Healthcare Opens Its Patient Assistance Program For People With HIV – On January 1, ViiV Healthcare, a joint venture by pharmaceutical companies Pfizer and GlaxoSmithKline, opened its patient assistance program to help low-income people with HIV obtain their medications. The program will cover the medications Combivir (zidovudine/lamivudine), Epivir (lamivudine), Epzicom (abacavir/lamivudine), Lexiva (fosamprenavir), Rescriptor (delavirdine), Retrovir (zidovudine), Selzentry (maraviroc), Trizivir (zidovudine/lamivudine/abacavir), Viracept (nelfinavir), and Ziagen (abacavir). Eligible participants must have an annual household income of no more than 500 percent of the federal poverty level ($72,850 for a family of two) and no prescription drug coverage for brand-name drugs. Patients on Medicaid are eligible if they meet income requirements and have spent $600 or more out of pocket for their HIV medications. For more information or to apply for the program, please see the ViiV Healthcare website.

AIDS Healthcare Foundation Offers Free HIV Drugs To People On Florida ADAP Waiting Lists – The AIDS Healthcare Foundation (AHF), a California-based treatment and advocacy group for people with HIV and AIDS, announced today that it will provide up to $1 million in free HIV drugs to people who have been placed on an AIDS Drug Assistance Program (ADAP) waiting list in Florida or have been removed from the program due to new, stricter eligibility requirements. ADAPs are programs that provide anti-HIV medications to low-income people with HIV. The offer from AHF is expected to benefit about 2,850 people and is intended to allow time for them to transition to private patient assistance programs without interrupting treatment. The HIV drugs will be distributed by AHF’s pharmacies throughout the state. For more information, please see the AHF press release.

Maine Now Requires Registration Cards For Medical Marijuana Use – A new state law that went into effect January 1 now requires registration for people in Maine who wish to use medical marijuana. Previously, the state only required a doctor’s permission for marijuana use. Applications for a registration card can be found on the Maine Department of Health and Human Services website; cards cost $100 ($75 for patients in the state’s Medicaid program, MaineCare). The new law also restricts the amount of marijuana a person can carry to 2.5 ounces and limits the number of marijuana plants a patient or their caregiver is allowed to grow. In addition, it provides for new medical marijuana dispensaries, which are expected to open in March or April. Medical marijuana has been legal in Maine since 1999 for treatment of symptoms related to specific conditions, including HIV and AIDS. For more information, please see the article at the Portland Press Herald.

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Study Suggests Genetic Tests Could Predict HIV Drug Side Effects

January 3, 2011

A new study published in the January 15 issue of The Journal of Infectious Diseases suggests genetic testing might help predict whether a person will have side effects from some HIV drugs. This could allow people to avoid those drugs or at least take them with greater caution.

Previous studies have found that side effects can result in switching meds or discontinuing treatment in up to 45 percent of people starting HIV therapy for the first time. Thus far, however, researchers have found only one form of a gene (an allele) conclusively responsible for side effects: The HLA-B5701 allele, which causes people to have a hypersensitivity reaction to abacavir (found in Ziagen and Epzicom).

Other alleles have been linked to changes in drug blood levels or increased side effect risks for other HIV medications, but the influence of these alleles isn’t as predictable as that of the HLA-B5701 allele.

To determine whether other alleles might predict poor tolerability to drugs other than abacavir, Rubin Lubomirov, MD, PhD, from the University of Lausanne in Switzerland, and his colleagues analyzed data from 577 people enrolled in the Swiss HIV Cohort study. All of the people were starting HIV treatment for the first time.

The specific drugs they studied were abacavir, tenofovir (found in Viread, Truvada and Atripla), efavirenz (found in Sustiva and Atripla), Kaletra (which contains lopinavir and ritonavir) and Norvir (ritonavir)–boosted Reyataz (atazanavir).

Based on data linking alleles to side effects or drug level changes in previous studies, Lubomirov and his colleagues tested collected blood samples for 23 alleles in 15 genes.

The only significant genetic switch not included was the HLA-B5701 allele, because all people who took abacavir had already been tested for the allele and only those without it were allowed to take abacavir. With some drugs, the researchers looked at whether a single allele affected a drug’s tolerability, and with other drugs, Lubomirov’s team looked at the combined effect of several alleles.

The team did not directly assess the effect of certain alleles on specific side effects. They focused only on whether the alleles predicted dose adjustments or treatment discontinuation (though the most common reason for switching treatment in the study was side effects).

The team found that the presence of drug-specific alleles was highly predictive of a switch from efavirenz or Reyataz, but not for the other drugs.

Lubomirov’s group found that 71 percent of people with alleles in the CYP2B6 gene combined with secondary alleles to other genes had to switch off efavirenz or change the dose of the drug compared with only 28 percent of those who did not have the alleles. The risk was even higher in women.

Likewise, Lubomirov and his colleagues found that 62 percent of people with a double substitution in the UGT1A1 gene had to change or discontinue Reyataz, compared with 24 percent with a single substitution and only 15 percent with no substitutions.

“The study suggests that assessment of the genetic markers could lead to improved prescription of atazanavir and efavirenz,” the authors state. They conclude that “a prospective clinical trial should ideally formalize the analysis and provide the basis for measuring the cost effectiveness of this approach.”

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