Progress toward solving the AIDS crisis seems to move at a torturously slow pace, and it is a bright day when new developments in HIV therapies appear. In 1996, the impact of triple combination antiretrovirals seemed miraculous, and the dramatic decline in U.S. AIDS death statistics that soon became evident continues to this day. AIDS was not eradicated and HIV-related deaths did not cease, but the daily devastation was brought under control wherever the drugs were available. Unfortunately, the miracle is denied to most people living with AIDS in the world because their governments are not yet willing or able to provide the drugs. Although the number receiving antiretroviral treatment continues to rise, at nearly 8,000 per day, the
global AIDS death rate remains out of control.
The Conference on Retroviruses and Opportunistic Infections (CROI) is the most important AIDS science meeting of the year. The conference organizers run a tight ship, with attendance generally limited to working scientists and a sprinkling of community members involved with treatment advocacy and education.
A large multicenter study, conducted in Honduras and Brazil, has shown that a new and relatively simple technique to detect active tuberculosis (TB), the microscopic observation drug susceptibility (MODS) test, is just as sensitive but about three times faster than conventional solid culture, the gold standard for confirming a diagnosis of active TB—yielding clear results in a median of seven days, compared to three weeks for solid culture. In addition, in a smaller subset of patients, MODS performance was similar to that of the automated liquid culture system, the MGIT 960, which is now widely used in industrialized countries. However, MODS' "low cost, relative to other liquid culture methods, may make it feasible for
use in resource-limited countries," wrote the authors of the study, published in the March 1st edition of Clinical Infectious Diseases.
There are a large number of experimental drugs now being developed to treat hepatitis C virus (HCV) infection. A race is on to find new HCV drugs because millions of people may one day require treatment, and the current generation of drugs are difficult to tolerate and do not reliably cure the potentially deadly liver infection (unlike HIV, HCV infection can sometimes be cured). The outcome for untreated HCV can be decompensated cirrhosis requiring transplantation—or if no donor liver is available, death. The outlook for people infected with both HIV and HCV is worse and, in the US, blacks typically have poorer treatment outcomes than whites.
The DART trial is a 6 year randomized trial of ART monitoring strategies in adults with symptomatic HIV and CD4 <200 cells/mm3 initiating ART in Kampala and Entebbe (Uganda) and Harare (Zimbabwe). Of the 3316 DART participants, 1867 are women of child-bearing age <45 years. At the 14th Retrovirus Conference in Los Angeles, a poster authored by Letitia Namale from Uganda and coworkers presented findings from an evaluation of pregnancy and pregnancy outcomes among women participating in the DART trial at a median of 2.8-years of follow-up.
Recent outbreaks of acute hepatitis C virus (HCV) among HIV-positive men who have sex with men (MSM) have been reported in England, France, Germany, Holland, and the United States. Many of these cases were sexually transmitted, which is unusual because HCV is typically transmitted via injection drug use. Furthermore, many of these men were HIV-positive before they got acute HCV.
GMHC Treatment Issues: April / July - Volume 20, Numbers 4, 5, 6, 7
The greatest unmet medical need in HIV medicine worldwide is for better treatments for people starting treatment for the first time (treatment-naïve patients). With 40 million people infected worldwide and perhaps a quarter of them in immediate need of treatment, the world has made great progress in the past few years in bringing antiretroviral (ARV) drugs to more than a million people in Africa and elsewhere in the developing world. Yet a huge gap remains in the availability of treatment, and over 7,000 people with HIV continue to die everyday.
In parts of the developing world, particularly in Africa, the price of antiretroviral drugs has come down dramatically over the past four or five years. A generic combination of nevirapine, lamivudine and stavudine used for first-line therapy can be had for under $150 per year. While this is an effective and lifesaving combination that has enabled a half-million people to begin therapy, there are side effects associated with stavudine, and resistance to nevirapine can arise quickly if adherence is not near perfect. This means that, as the number of people going on first line therapy grows, the number of people who are failing or intolerant of those drugs is also growing, which, in turn, creates a growing need for second-line therapy.
In July 2006, members of the International Treatment Preparedness Coalition's (ITPC) World CAB met with Gilead Sciences, the makers of Viread (tenofovir) and Truvada (tenofovir/emtricitabine) to discuss the company's plans for making their drugs available at affordable prices to ARV treatment programs in the developing world.
Antiretroviral therapy (ART) may delay liver disease progression in people coinfected with viral hepatitis by preserving immune function. Conversely, viral hepatitis coinfection complicates HIV treatment, because it increases the risk for treatment-associated hepatotoxicity (liver injury) and discontinuation of antiretroviral therapy.
With a wave of new HIV drug approvals expected over the next year or so, we may finally see a dramatic reduction in the number of people with HIV who find themselves "unable to construct a viable regimen"; the classic definition of the so-called "salvage" patient who has developed resistance to nearly every available antiretroviral treatment option.
GMHC Treatment Issues: January / March - Volume 20, Numbers 1, 2, 3
In the bad old days—before effective combinations of HIV medications dramatically rolled back the tide of suffering and death from AIDS in this country—informed patients-turned-activists helped institute a revolution in drug development that allowed people with no hope to obtain promising new antiretroviral (ARV) drugs before the FDA had approved them. Initially called "parallel track"—because it was a separate way to simultaneously access drugs outside of ongoing clinical trials—early or expanded access programs (EAPs) became an expectation with every new drug.
The need for ethical, well-designed trials that provide clear, quick answers has never been more pressing. Some have suggested that validation of new therapies takes so long as to be virtually useless. However, we cannot allow this crisis to eliminate requirements for sound efficacy evaluation. It is grossly unethical to require PWAs to make treatment decisions in an informational vacuum any longer than is absolutely necessary.
Clinical research sites typically get little if any funding from drug companies to run expanded access programs for investigational HIV drugs, yet these projects probably consume more site staff time than most conventional research studies. A few busy research sites, particularly those associated with large universities, have recently refused to open expanded access programs due to the uncompensated burdens of administration. If this trend continues, then in the future there will be fewer opportunities for patients to obtain access to desperately needed new treatment options.
HIV clinical trials, like other studies that test medical hypotheses in humans, embody a fundamental ethical tension. The immediate well-being of clinical trial participants, even those who might benefit greatly from certain experimental regimens, is implicitly being weighed against the future well-being of other unknown people.
Rebecca Pointer, Rene Loewenson, Gregg Gonsalves From EQUINET, June Newsletter
When the United Nations General Assembly met in June to review progress in tackling the AIDS epidemic it was reminded by civil society globally of the commitment made to ensure universal access to treatment for AIDS by 2010. This commitment has greatest resonance in sub-Saharan Africa where AIDS-related mortality is highest.
Previous studies investigating the pharmacokinetics (PK) of protease inhibitors (PIs) show reduced exposure during pregnancy. M. Regazzi and coworkers from a multicenter cohort in Italy evaluated nelfinavir and lopinavir plasma levels in a group of HIV-positive pregnant women after receiving multiple doses.
We are a group of women and men living with HIV who are concerned about the limited amount of information available on the effects of HIV drugs on women. We believe that research on women should be a high priority but that too many barriers prevent women from joining research studies.
This information is designed to support, not replace, the relationship that exists between you and your doctor.