GSK and Pfizer to Merge HIV Drug Units in New Company, Sixteen States Inconsistent With CDC HIV Testing Recommendations

June 8, 2009
Ned E. Heltzer, RPh, MS
Ned E. Heltzer, RPh, MS

Volume 19, Issue 6

London-based GlaxoSmithKline (GSK) plc and New York–based Pfizer Inc have announced they will combine their HIV drug divisions into a new company (Kelley T. Bloomberg News. April 16, 2009). GSK will hold an 85% share of the joint venture; Pfizer will hold 15%. According to a filing with the US Securities and Exchange Commission, GSK Senior Vice President Dominique Limet, a physician, is CEO-designate of the new company.

GlaxoSmithKline, Pfizer to Merge HIV Drug Units in New Company
London-based GlaxoSmithKline (GSK) plc and New York–based Pfizer Inc have announced they will combine their HIV drug divisions into a new company (Kelley T. Bloomberg News. April 16, 2009). GSK will hold an 85% share of the joint venture; Pfizer will hold 15%. According to a filing with the US Securities and Exchange Commission, GSK Senior Vice President Dominique Limet, a physician, is CEO-designate of the new company. “With the strength of the companies’ current products, as well as the complementary fit of Pfizer’s pipeline and Glaxo’s global distribution capabilities, the new company is well-positioned to bring new and improved medicines to patients with more speed and efficiency,” said Pfizer CEO Jeff Kindler. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Thursday, April 16, 2009]

Sixteen States Inconsistent With CDC HIV Testing Recommendations for Health Care Settings
In an effort to improve screening for and diagnosis of HIV infection, the CDC released its “Revised Recommendations for HIV Testing of Adults, Adolescents and Pregnant Women in Healthcare Settings” in September 2006. These guidelines call for all patients aged 13 to 64 years in health care settings to be offered HIV screening on an opt-out basis, without separate written consent and prevention counseling. However, state laws that address HIV testing are widely assumed to be a barrier to the implementation of these recommendations.

In order to help policy makers and providers better understand their own legal context and to correct possible misunderstandings about statutory compatibility, researchers undertook a state-by-state review of all laws pertaining to HIV testing. Their review, which included Washington, DC, systematically assessed the consistency of the state laws with the 2006 recommendations. The state regulations were classified as neutral to or consistent or inconsistent with the new regulations. The study also examined the implications for implementation of the recommendations in theses various legal contexts.

The authors found that in 34 states and Washington, DC, statutory frameworks were either consistent with or neutral to the CDC guidelines, which would thus enable their full implementation. In 16 states, statutory frameworks were found to be inconsistent with the recommendations. Barring legislative change, this would preclude implementation of one or more of the novel provisions of the recommendations. In the 2 years since the CDC guidelines were published, 9 states have passed new laws to move from being inconsistent to being consistent with the guidelines.

“State statutory laws are evolving toward greater compliance with the CDC recommendations,” the authors concluded. “Policy makers, provider groups, consumer advocates, and other stakeholders should ensure that HIV screening practices comply with existing state law and work to amend inconsistent laws if they are interested in implementing the CDC recommendations,” the authors concluded. The study’s findings were published in the Annals of Internal Medicine (Mahajan AP, Stemple L, Shapiro MF, et al. Consistency of state statutes with the Centers for Disease Control and Prevention HIV testing recommendations for health care settings. Ann Intern Med. 2009;150:263-269). [CDC HIV/Hepatitis/STD/TB Prevention News Update, Tuesday, April 7, 2009]

Bayer Antibiotic May Shorten Treatment of TB
In a new study, a drug approved to treat pneumonia showed promise in improving tuberculosis (TB) treatment rates (Cortez MF. Bloomberg News. April 3, 2009). Mycobacterium tuberculosis infects roughly 8.8 million people and the infection kills 1.7 million annually. An uncomplicated case of the disease typically takes 6 months to treat, but many patients with uncomplicated TB fail to complete the 6-month treatment regimen. As a result, a half-million people contract drug-resistant TB each year.

Researchers led by Richard Chaisson of Johns Hopkins University School of Medicine studied 170 TB patients treated at a hospital in Rio de Janeiro. The study was funded by the NIH and the FDA’s Office of Orphan Products Development.

The study found that 80% of patients given the antibiotic moxifloxacin and the standard 3-drug TB treatment had no signs of M tuberculosis in their saliva after 8 weeks. That rate compares with around 63% of those given an older medication with the standard treatment. Moxifloxacin is sold under the trade name Avelox by German drug maker Bayer to treat pneumonia. “Moxifloxacin, in combination with other first-line antituberculosis drugs, could shorten the time needed to cure [TB] by several months,” the study team reported. “A reduction in the duration of [TB] therapy would substantially improve outcomes.”

In an accompanying editorial, Hans L. Rieder of the Switzerland-based International Union Against Tuberculosis and Lung Disease noted that moxifloxacin’s benefit was “surprisingly large.” “However, it remains to be seen” if newer antibiotics like Avelox will allow treatment to be shortened, he said. “What is needed, and perhaps in reach, is a regimen that is well-tolerated, of reasonably short duration, without an unacceptably high frequency of adverse drug effects, and thus an effective treatment,” said Rieder.

The results of the study were published in The Lancet (Conde MB, Efron A, Loredo C, et al. Moxifloxacin versus ethambutol in the initial treatment of tuberculosis: a double-blind, randomized, controlled phase II trial. Lancet. 2009;373:1183-1189; and Rieder HL. Fourth-generation fluoroquinolones in tuberculosis. Lancet. 2009;373:1148-1149). [CDC HIV/Hepatitis/STD/TB Prevention News Update, Wednesday, April 15, 2009]

Cepheid Unveils Fast TB Test to Aid Developing Countries
The California-based molecular diagnostics firm Cepheid announced in March that it has created a rapid tuberculosis (TB) test and will offer it at a reduced cost to developing countries (Tansey B. San FranciscoChronicle. March 25, 2009). The automated, DNA-based test also detects drug resistance, which will allow patients with drug-resistant TB to receive appropriate treatment immediately and reduce the chances of transmission, said Dr David Persing, Cepheid’s chief medical officer.

A traditional “smear test” looking for Mycobacterium tuberculosis in sputum on a slide under a microscope does not always detect disease, and it cannot distinguish between resistant M tuberculosis strains and strains vulnerable to frontline drugs, Persing said. Further tests for more complete information can take weeks, he said.

Cepheid’s TB test detects DNA sequences unique to M tuberculosis and to drug resistance. The firm’s Gene-Xpert System packs all the laboratory processes for the test into a cartridge, which is loaded into a machine that can read the results. The readers can be as small as a textbook, which can allow for mobile TB testing far from hospitals, Persing said. Cepheid will sell the test in sub-Saharan Africa and other developing regions for the cost of the equipment and other expenses, such as shipping, he said.

Cepheid will also seek FDA approval for its TB test for the US market by early 2010, Persing added. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Thursday, March 26, 2009]

Economic Crisis Threatens AIDS Fight
The executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria warned that disease-fighting efforts could be jeopardized by the worldwide financial crisis. Speaking during the International Harm Reduction Association (IHRA) conference in Bangkok, Thailand, in April 2009, Michel Kazatchkine worried that fund donors will be unable to meet their pledges (Kemp D. Agence France Presse. April 20, 2009).

“The financial crisis obviously is affecting the rich countries and therefore I am very concerned about their ability to keep up development aid commitments,” said Kazatchkine. “In global health, it is a slow slope to make progress, it takes you time to actually see the gains. If the efforts are not sustained we will lose a lot of gains that we have made in the last six to eight years.”

The Global Fund is expected to have a $4 billion budget deficit for the 2008 to 2010 period. This shortfall, Kazatchkine said, threatens HIV prevention and treatment programs in the developing world. “This is why, paradoxically, it is during a financial crisis that you need even more funding,” he said.

During his keynote speech to the IHRA, the Global Fund head called for decriminalizing drug use as a way to slow the spread of HIV/AIDS. “I am talking about decriminalization of drug users,” said Kazatchkine. “I am not talking about decriminalization of drug trafficking, there should not be any misunderstanding.”

“Drug users have been looked [upon] as criminals; they are arrested, harassed; they are imprisoned; they have no access to services; they are not respected in the very basic human rights perspective,” Kazatchkine added. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Monday, April 20, 2009]

Time to Overhaul Action for Children Hit by AIDS
Global efforts to help children affected by HIV have fallen short and should be retooled to focus on the family, according to a new report released Tuesday by the Joint Learning Initiative on Children and HIV/AIDS (JLICA) (Agence France Presse. February 10, 2009). The independent alliance of researchers, policymakers, and advocates compiled more than 2 years of research for the report, entitled “Home Truths.”

The successful campaign to provide antiretroviral drugs for HIV/AIDS patients in poor countries has eclipsed a cruel failure to help children who are infected and orphaned by HIV/AIDS, the report said. Children with HIV/AIDS are “significantly less likely” to have access to antiretrovirals and they face barriers to educational and social opportunities, the authors noted. “Families’ effectiveness in absorbing the shocks of HIV and AIDS and other afflictions points to a crucial lesson: strong, capable families must be the foundation of any long-term response to children affected by AIDS,” the report said.

Poor families need practical assistance, such as “income transfer” programs that offer poverty grants, child support grants, and food aid for families facing scarcity. These programs provide “efficient and direct” support, the JLICA said. Placing a child in an orphanage leads to worse outcomes and costs up to 10 times more than providing him or her a home in an extended family, the report found. “Families’ unique advantages in nurturing children can operate only if families have a basic level of material resources,” it observed.

The full report can be viewed at http://www.jlica.org/protected/pdf-feb09/Final%20JLICA%20Report-final.pdf. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Thursday, February 12, 2009]

A Policy Cocktail for Fighting HIVNote: The following are selected excerpts from an editorial by Anthony S. Fauci published in the Washington Post on April 16, 2009.

“In the absence of a vaccine, three bold new approaches to controlling the HIV/AIDS pandemic are being discussed by those working in medicine and public health. These approaches are still in the conceptual and testing phases, but if applied as a group, it’s possible they could have a dramatic effect.

“The first approach would provide a daily dose of antiretroviral medicines to people who are not infected with HIV but are at high risk of becoming infected. This strategy, known as preexposure prophylaxis, or PrEP, is based on the concept that blocking HIV’s replication immediately after exposure to the virus may prevent infection.

“The National Institutes of Health and other organizations are conducting clinical PrEP trials among various at-risk populations. Initial findings are expected later this year.

“The second approach would involve universally available, voluntary, annual testing for HIV infection and immediately providing antiretroviral therapy to those who test positive. The potent combinations of antiretroviral medicines available today can suppress the amount of HIV in an infected person’s body to extremely low levels, resulting in longer lives and better health.

“Plus, it has been clearly shown that those who have less HIV in their blood are less infectious to others. . . . New modeling research suggests that implementing a voluntary ‘test and treat’ approach could dramatically reduce new HIV cases beginning within a decade and ultimately halt the pandemic.

“. . . Before this approach can be implemented, however, we must pursue a research agenda that includes studies of feasibility, efficacy, the benefits to individual patients vs the benefits to society, and cost-effectiveness.

“The third approach . . . might entail purging all vestiges of the virus from a person’s body, a difficult challenge. Perhaps more likely, though still difficult, would be a ’functional cure’-therapies that suppress the virus to such low levels that an HIV-infected person would no longer need treatment because his or her immune system could keep the residual virus in check. The latter result would be more likely if therapy were initiated early in the course of infection, when significant immune function remains. The NIH plans soon to launch an initiative designed to solicit novel ideas for an HIV cure from the scientific community.”

The author is director of the National Institutes of Allergy and Infectious Diseases. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Monday, April 20, 2009]