Treatment Issues, Volume 12, Number 12 - December 1998
Derek Link
The 105th Congress went home in December, ending one of the most intensely partisan and confusing Congresses in living memory, which included: historic increases in AIDS funding, inaction on major legislation, changes in leadership and committee membership, and the impeachment of President Clinton by the House of Repre
Treatment Issues, Volume 12, Number 12 - December 1998
Linda Grinberg
Last August, news leaked that DuPont Pharmaceuticals and Glaxo Wellcome were about to set unparalleled prices for their new drugs, efavirenz (brand name Sustiva ) and
Treatment Issues, Volume 12, Number 12 - December 1998
Michael Norton, P.A.
Prior to 1989, what we now characterize as hepatitis C was called either non-A, non-B or transfusion-associated hepatitis. Approximately 4 million Americans are currently infected with HCV, and 8 to 10 thousand Americans die each year due to HCV complications. At current rates of disease progression, these numbers will
Treatment Issues, Volume 12, Number 11 - November 1998
Jill Cadman
In 1996, the Centers for Disease Control (CDC) announced the first declines in AIDS deaths among men since the beginning of the epidemic. During the same time period, AIDS deaths among women increased by 3%. The situation improved in 1997 when women experienced a 37% decline in AIDS-related deaths. This still was not e
Treatment Issues, Volume 12, Number 11 - November 1998
Dave Gilden
The coming of efavirenz and abacavir to market considerably expands the possibilities for simplifying the schedules of antiviral regimes. Efavirenz is taken as three pills once a day whereas abacavir dosing consists of one pill twice a day (see previous article). But these two agents are just the newest of many options
Treatment Issues, Volume 12, Number 11 - November 1998
Dave Gilden
The thirteenth HIV drug is about to enter the market: After a day s worth of agonized debate, the FDA Antiviral Advisory Committee recommended approval of Glaxo Wellcome s abacavir (brand name: Ziagen ) by a 7-2 vote. At Treatment Issues press time, official FDA approval was imminent.
Treatment Issues, Volume 12, Number 10 - October 1998
Luis Santiago
After years of debate among scientists on whether the current crop of candidate HIV/AIDS vaccines merits moving ahead into efficacy studies, the small biotechnology company VaxGen has launched the first ever large-scale efficacy trial of a potential preventive HIV vaccine in sites across the
Neuropathy is characterized by burning, aching, numbness and tingling, most commonly in the legs and feet. It is a result of damage to nerve fibers and is caused by either HIV itself or the toxic effects of certain antiretroviral drugs (usually d4T , ddI or
On September 18, Merck & Co. publicly warned against taking its protease inhibitor indinavir ( Crixivan ) on a twice-daily dosing schedule of 1200 mg every 12 hours. The standard schedule is 800 mg three times a day, but many doctor
Gilead Science has been developing a class of broad-spectrum antiviral agents called nucleotide analogs for over five years. To date, cidofovir ( Vistide ) has been approved for the treatment of AIDS-related CMV retinitis and adefovir (Preveon) is in an expanded access program for the t
Since protease inhibitors burst on the scene in 1995, they have overshadowed almost everything else, including the other relatively new class of antiretrovirals -- the non-nucleoside reverse transcriptase inhibitors (NNRTIs). During early clinical trials, the NNRTIs were used as monotherapy or in less than maximally su
With lightening speed, the FDA has reviewed the New Drug Application for efavirenz ( Sustiva ) and approved the drug without so much as an advisory committee hearing. The quick efavirenz review took a mere three months, but that only put the final punctuation point on the drug s rapid development: The first h
DuPont Pharmaceutical s new drug efavirenz ( Sustiva ) has enjoyed a favored position among treatment activists, offering both high levels of antiviral activity and a simplified dosing regimen. The company has worked to build a harmonious relationship with the communi
Treatment Issues, Volume 12, Number 7/8 - July/August 1998
Jill Cadman
On July 27, Abbott Laboratories arranged a last-minute conference call to announce that unforeseen ritonavir ( Norvir ) production problems had forced the company to discontinue manufacture of the capsule formulation. By mid-August, Abbott announced, all available capsules would be gone from pharmacy shel
Treatment Issues, Volume 12, Number 7/8 - July/August 1998
Jill Cadman
Research to eliminate mother-to-child HIV transmission (vertical transmission) was one of the highpoints at the 12th World AIDS Conference. Several very encouraging reports on the effectiveness of Cesarean sections (C-sections) were presented. Several studies also assessed the benefits and safety of
Treatment Issues, Volume 12, Number 7/8 - July/August 1998
Jill Cadman
Reports of multiple metabolic abnormalities in HIV-positive individuals on highly active antiretroviral therapy (HAART) continue to mount. At the 12th World AIDS Conference in Geneva, presentations from all parts of the world depicted a group of unusual and distressing symptoms. The syndrome of abnormal redistribution
Treatment Issues, Volume 12, Number 7/8 - July/August 1998
Luis Santiago
Several significant developments related to hydroxyurea (HU) were discussed at the 12th World AIDS Conference in Geneva. A new clinical trial confirmed the capacity of the triple-drug combination regimen of ddI/ d4T /HU to substantially reduce HIV viral loads in naïve patients. Two laboratory studies showed that HU enh
Treatment Issues, Volume 12, Number 7/8 - July/August 1998
Dave Gilden
The last International AIDS Conference was held two years ago, just after the first three protease inhibitors were approved. It was also a mere seven months after 3TC arrived at drugstores, marking the final demise of the era of
Last month s interview with Dr. Joseph Sonnabend concerning the risk of coronary heart disease in those on protease inhibitors , mentioned the protective benefits of cholesterol-lowering drugs but missed an important point. Most such drugs belong to the class known as statins. These drugs are metabolized by the same
Recycling HIV drugs - the practice of collecting and transferring unused drugs from one patient to another - is becoming increasingly prevalent. Individuals often act independently, but community-based organizations are also involved in sending drugs to developing countries. On April 29, 1998, GMHC, in collaboration wi
The Joint United Nations Programme on HIV/AIDS ( UNAIDS ) announced the pilot phase of its HIV Drug Access Initiative last November (see Treatment Issues, Winter 1997/1998, page 32). The program addresses the inadequacy of medical care and treatment in the developing world. Four nations were selected to participate in
The article by Sarah Palmer in this edition of Treatment Issues refers to the use of cell culture assays to determine what drugs a particular HIV isolate can resist. By comparing the isolate s activity in the presence or absence of a series of drugs, researchers can construct an accurate resistance profile for that iso
Sarah Palmer, Ph.D., Post-Doctoral Fellow, Center for AIDS Research, Stanford University Medical Center
Drug-resistant HIV strains are a major cause of treatment failure in the management of HIV infection. These resistant viral strains can evolve whenever the virus is not fully suppressed by a particular drug treatment regimen. Long-term therapy with suboptimal drug regimens, poor drug absorption, or noncompliance with e
Ligand Pharmaceuticals has filed a request for FDA approval of Panretin gel (9-cis retinoic acid) as a topical treatment for Kaposi s sarcoma. The submission is based on two 12-week phase III trials. In one conducted in North America, 35% of those applying Panretin gel showed some improvement in index KS skin lesions c
Everyone who uses Pfizer s new anti-impotence drug Viagra should know by now that it should not be used with poppers, or indeed any other nitrate compound (such as nitroglycerin, which is administered during heart attacks). Nitrates and Viagra have complementary effects, and when present together can lead to dangerous
While Upjohn moves to reduce its presence in the HIV arena, Glaxo just gets in deeper. The company already has two new antiretrovirals, abacavir and amprenavir , that will reach the market by the end of this year.
Rumors, partially confirmed by company officials, indicate that Pharmacia & Upjohn is considering selling its HIV drugs or at least finding a partner for their further development. The product line includes first of all the FDA-approved NNRTI delavirdine ( Rescriptor
DuPont Merck, which is soon to become simply DuPont Pharmaceuticals as the result of a recent buyout by DuPont, sent out a warning on May 21 concerning use of its new NNRTI (nonnucleoside reverse transcriptase inhibitor) efavirenz ( Sustiva ) along with the
About 12,000 people will be traveling to Geneva for the 12th World AIDS Conference in June-July, including many with HIV. Thousands of HIV-positive tourists will make other long-distance trips this summer. The time-zone changes they encounter will force adjustments in their medication schedules. The timing of taking
Evidence that post-exposure treatment (PEP) with zidovudine is associated with a significant (79%) decrease in the risk of occupational transmission of HIV (usually after a needlestick accident) has propelled many to consider post-sexual exposure prevention of HIV through antiretroviral therapy. There are many factors
While much attention has been focused on strange fat deposits in the abdomen and between the shoulder blades of some people receiving protease inhibitors , little has been said about the long-term effects of the high blood lipid levels also observed in those on protease inhibitors (see two reports on abnormal fat depos
Last December, Unimed Pharmaceuticals submitted a New Drug Application (NDA) for NTZ (brand name: Cryptaz). This was the first time a drug for treating cryptosporidiosis was brought to the FDA . Although NTZ is an antiparasitic, Unimed did not request that the FDA approve NTZ for treating the infection itself. The data
GMHC Treatment Issues, Vol. 12, No. 4; April, 1998
Gabriel Torres, M.D.
A study that could have global implications on the prevention of tuberculosis (TB) was presented as a late-breaker at the 5th Conference on Retroviruses and Opportunistic Illnesses held in Chicago in February (late breaker 5). Conducted in the United States , Brazil ,
GMHC Treatment Issues, Vol. 12, No. 4; April, 1998
Judith G. Rabkin, Ph.D., and Margaret A. Chesney, Ph.D.
Since the advent of antiretroviral combination therapy , adherence has become an extremely popular subject. The term appeared no less than seven times in the 1997 Federal Guidelines for the Use of Antiretroviral Agents in HIV-infected Adolescents and Adults.1 These days, adherence is a topic that is included in virtual
GMHC Treatment Issues, Vol. 12, No. 4; April, 1998
Dave Gilden
An experimental agent that promises to augment treatment strategies without running into cross-resistance with present antivirals is now entering phase II clinical trials. Trimeris Corporation s T-20 is a 36-amino acid peptide that forms part of the gp41 protein on HIV s outer coat. gp41 facilitates virus-cell fusion b
GMHC Treatment Issues, Vol. 12, No. 4; April, 1998
Jill Cadman
Estimates of the number of people on protease inhibitors who fail to achieve stable viral loads below quantifiable limits (less than 400 copies/ml by PCR) range as high as 70% in pretreated populations. Those who do not reach this plateau face the daunting prospect of either continuing on a regimen that allows viral br
Treatment Issues, Volume 12, Number 3 - March 1998
Jill Cadman
The Division of AIDS Services (DAIDS) has issued a pregnancy safety alert to its trial sites regarding efavirenz (also known as DMP 266 and Sustiva ) based on information provided by the drug s manufacturer, DuPont Merck. A study conducted by the company has found that severe birth defects occurred in 3 of 13 monkeys (
Treatment Issues, Volume 12, Number 3 - March 1998
Jill Cadman
In the last few years, medical breakthroughs have sharply reduced the rate of HIV transmission during pregnancy from about 25% to between 3-5%. The mechanism of mother-to-child ( vertical ) transmission is still not fully understood, though, and neither is the way in which drugs block that transmission. Research contin
Treatment Issues, Volume 12, Number 3 - March 1998
Dave Gilden
Glaxo Wellcome has finally announced the start of an expanded access program for its much heralded nucleoside analog abacavir. To qualify, they need only be failing or intolerant to standard therapy and, in the judgment of the physician, unable to construct a viable treatment regimen without abacavir. There are no C
Treatment Issues, Volume 12, Number 3 - March 1998
Jill Cadman
Aside from the new antiretroviral compounds that will, in all likelihood, be FDA-approved this year ( abacavir , amprenavir , efavirenz and adefovir -- for more information on these, see Treatm
Treatment Issues, Volume 12, Number 3 - March 1998
Dave Gilden
In February 1997, Treatment Issues commented that the 4th Conference on Retroviruses and Opportunistic Infections, reflected the gradual accretion of promising developments leading toward fulfilling the now years-long hope of making HIV infection a chronic manageable disease . This year s 5th Conference (held in Chicag
Treatment Issues, Volume 12, Number 2 - February 1998
Columbia University College of Physicians and Surgeons is performing a study of Kaposi s sarcoma-associated herpesvirus (KSHV/HHV-8). This recently discovered virus has been found to be associated with clinical forms of Kaposi s sarcoma, including the type that occurs in HIV-negative individuals. The laboratory of Drs.
Treatment Issues, Volume 12, Number 2 - February 1998
Tim Horn with Dave Gilden
A few years ago, about 9,000 cases a year of HIV-related Kaposi s sarcoma (KS) were diagnosed in the U.S. Potent anti-HIV therapies may now be decreasing the annual rate of new cases, but there are still 25,000 Americans living with AIDS KS today. This AIDS-defining condition, which consists of purplish tumors in the s
Treatment Issues, Volume 12, Number 2 - February 1998
Jill Cadman
Factors other than viral cross-resistance, such as pharmacological mechanisms, may also be important to take into consideration when planning a long-term strategy. The nucleoside analogs are actually prodrugs that must be converted into their active, triphosphate form by cellular enzymes in the human body. This is a th
Treatment Issues, Volume 12, Number 2 - February 1998
Jill Cadman
More and more people are embarking on the treatment merry-go-round following the aggressive stance outlined in the Public Health Service s antiretroviral treatment guidelines. There are numerous treatment options for antiretroviral-naive patients. The sequence in which these drugs are used could be an important conside
GMHC Treatment Issues; Vol 12, No. 1 December 1997/January 1998
Jill Cadman
The disparity between HIV haves and have-nots has become sharper and sharper with the growing list of new treatments. Only 10% of people infected with HIV live in countries where an adequate supply of HIV drugs is available, while limited resources make sophisticated HIV therapy beyond the reach of the other 90%. In re
GMHC Treatment Issues; Vol 12, No. 1 December 1997/January 1998
Jill Cadman
Since current anti- CMV drugs are so costly, toxic and difficult to administer, it would make a lot of sense to single out those most at risk for CMV disease for early, preemptive treatment. CMV PCR assays may turn out to be the way of identifying this population. At this year s Interscience Conference on Antimicrobial
GMHC Treatment Issues; Vol 12, No. 1 December 1997/January 1998
Jill Cadman
The current difficulties in enrolling CMV trials notwithstanding (see Treatment Issues, Sept. 1997, page 4), valuable new information on the disease is emerging, and investigations into new products and technologies are going forward. Reports from September s Interscience Conference on Antimicrobial Agents and Chemothe
GMHC Treatment Issues; Vol 12, No. 1 December 1997/January 1998
Alan Huff, D.C.
Ellen, a 42-year-old white female bookkeeper, has been on triple combination therapy for the last 12 months. During this time she has had an undetectable viral load. But, Ellen relates, The most unusual development has been breast enlargement. My breasts got round, full and plump and they stand out like the dancers in
GMHC Treatment Issues; Vol 12, No. 1 December 1997/January 1998
Dave Gilden
In this special double issue, Treatment Issues presents the results of its second survey of physicians practices. Our first survey, conducted in the spring of 1996 just as the first crop of potent antiviral agents was entering the market, revealed a wide range of improvisations by physicians. Doctors answered the class
Treatment Issues: Newsletter of Experimental AIDS Therapies - Volume 12, Number 1, December 1997-January 1998
Dave Gilden
Four new anti-HIV drugs will probably reach the U.S. market in the coming year, making a grand total of 15 such agents. At first glance, the new agents represent distinct improvements over existing drugs and should result in greater treatment options and more flexible therapeutic strategies. The big drawback is that th
This information is designed to support, not replace, the relationship that exists between you and your doctor.