published by We The People Living with AIDS/HIV of the Delaware Valley, Inc.
Crixivan, Norvir added to state drug list
FDA "reform", HOPWA move ahead in Congress
Herpes virus implicated in retinal infections
Research questions switch to ddI for AZT-intolerant patients
With the announcement, the state now pays for 58 HIV/AIDS drugs and treatments. Of this total, more than half were added by the Ridge administration.
Ridge's action follows an order from the Clinton administration that informed state Medicaid programs that they must cover the three newly approved protease inhibitors as part of regular prescription coverage. Some states have begun cutting back on funding for AIDS drugs because of declining federal support for state Medicaid and welfare programs.
The administration also cautioned states to be careful not to "excessively or unreasonably restrict" coverage of any HIV/AIDS therapies. Sally K. Richardson, director of the Medicaid Bureau at the Department of Health and Human Services, said that limiting access to drugs needed by HIV-infected patients can have "serious ramifications, including the emergence of resistance if such drugs are discontinued."
Crixivan (indinavir) and Norvir (ritonavir) are protease inhibitors, which are being touted for their significant clinical effects in combating HIV/AIDS. The drugs will be provided
through the Department of Public Welfare's Special Pharmaceutical Benefits Program, which helps moderate-income people with HIV and AIDS pay for the high cost of medications.
In February, the state also added the protease inhibitor Invirase to its list of drugs.
"With the addition of Crixivan and Norvir to our stockpile of drugs, we are excitedly optimistic that we can significantly prolong the quality of life for people with AIDS and their families," DPW Secretary Feather O. Houstoun said. "Clinical information suggests that these two drugs are highly effective in slowing the growth of HIV in infected individuals.
"This new ray of hope allows us to provide people who need our help the opportunity to live independent, productive lives."
Crixivan and Norvir have been reported to be more effective than Invirase in slowing the growth of HIV-infected cells, thus reducing opportunistic infections that are usually fatal. They have also been proven successful when used in combination with certain anti-viral drugs covered by the Special Pharmaceutical Benefits Program.
Currently, the state's $5.7 million drug assistance program serves nearly 2,000 people.
To be eligible, individuals must reside in Pennsylvania (but not in any institution where these medications are available); have an individual gross income of less than $30,000 or a family income of less than $30,000 with an allowance of $2,480 for additional family members; and have a medical need for the drug.
Applications are available from county assistance offices, AIDS service agencies, hospital social service departments, state health centers, hemophilia and renal dialysis centers, mental health centers, and some physicians and pharmacies.
For more information about the program, or applications, persons can call DPW's toll-free hotline at 1-800-922-9384 or write to: Department of Public Welfare, Special Pharmaceutical Benefits Program, P.O. Box 8021, Harrisburg, Pa. 17105.
3TC shines in Glaxo trial
Drug companies have announced that trials of a "cocktail" of AIDS drugs had been so successful they were giving one of the drugs, 3TC, to everyone in the trial.
Glaxo Wellcome Plc said a combination of its 3TC (Epivir) along with the standard HIV drug AZT, and sometimes with other drugs, caused a 54 percent drop in progression to AIDS or death.
An independent group of scientists set up by Glaxo, which licenses Epivir from the Canadian company BioChem Pharma Inc, recommended the move 16 months after the study started in March 1995. It was due to end in March 1997 but has now been stopped.
Glaxo said halting the trial would allow all the nearly 2,000 participants to benefit. Under the experiment, some were given the drug and others were not.
"Expectations for Epivir have been gradually rising as the idea of using it as one of the mainstays of these cocktails has become conventional wisdom," said SG Strauss Turnbull pharmaceuticals analyst Paul Diggle.
The study, known as Caesar, included 1,892 HIV patients from Canada, Australia, Europe and South Africa.
Cocktail therapy is the new treatment of choice for physicians treating people with HIV/AIDS. Scientists reported at the international conference on AIDS in Vancouver that combinations of three or more drugs may be able to wipe out all evidence of HIV.
Although they cannot tell how long the effects will last -- and AIDS can take more than a decade to develop -- they hope the combination therapies offer the first clues to a cure.
Nick Partridge of British AIDS charity the Terrence Higgins Trust welcomed the findings with some reservations. "Overall, this confirms the benefits of combination therapy," he said.
"However, what we don't know from this initial analysis is the impact of resistance and the development of resistance. One of the strong themes that came out of Vancouver is that just adding one drug to a combination is not necessarily the best way to maximize the impact of three-drug therapy."
He added: "This trial raises as many questions as it answers. It does not provide any clear, definitive answers as to what combinations people with HIV should take."
Glaxo's Caesar trial did not use any protease inhibitors. A spokesman said the 54 percent result was an average of patients given AZT plus 3TC, as well as those given AZT, 3TC and either ddC or DDI.
AIDS Ride benefits in dispute
The release of a preliminary report on the proceeds of the Philadelphia-to-Washington AIDS Ride last month, indicating that net proceeds of the event -- which raised close to $1.5 million -- might be little more than $100,000 after expenses, led to controversy this week.
Advocates said that the high overhead cost of the Ride diverted hundreds of thousands of dollars to promoters and logistical expenses, with little left over to actually help people living with HIV/AIDS. Proponents -- who said that the actual proceeds from the June event were more likely to be close to $500,00 -- said that the proceeds were appropriate for the first Ride and that it takes several Rides to build a firm constituency for the event.
Ride sponsors said that the actual totals of incomes and expenses for the Ride would not be available until the middle of August.
FDA "reform", HOPWA move ahead in Congress
While the House Commerce Committee is still engaged in redrafting their legislation to reform the Food and Drug Administration (FDA), the bill is moving rather swiftly in the Senate. The Senate FDA reform bill (S. 1477) is unacceptable to many AIDS and other advocacy groups because it will make it more difficult for the FDA to prioritize approvals for drugs that treat serious and life-threatening diseases; lower the FDA's standard for safety and effectiveness by making FDA prove that a drug or medical device is unsafe and ineffective rather than having the drug or device company prove it is safe and effective; and jeopardize the health of patients in clinical trials by limiting FDA's ability to stop a trial even when investigators are unqualified or sponsors have submitted misleading information to investigators. It will allow sponsor companies to keep information from reaching the FDA about deaths or withdrawals of participants from clinical trials.
The Administration is still attempting to negotiate important changes in the bill but it is crucial that AIDS and other patient advocates ask their senators to vote against S. 1477 in its current form.
HOPWA funding level to be set soon
Meanwhile, the Senate Labor/HHS appropriations subcommittee has postponed the mark up of its bill (the mark up sets funding levels for AIDS prevention, care and research programs) to the first week in September. The Senate is expected to provide a significant increase for all biomedical research at the National Institutes of Health and to include the consolidated AIDS research appropriation to the Office of AIDS Research (OAR).
Also, the Senate is expected to consider the FY 97 VA/HUD Appropriations by the week of July 29th. The Housing Opportunities for People with AIDS program is flat-funded at $171 million for FY 97 in both the House and Senate bills. However, the Senate bill is considered by AIDS advocates as much worse than the House version, because the HUD portion -- which includes HOPWA -- was funded at $202 million less than what the House bill provides. This makes it unlikely that funding for HOPWA can be increased on the Senate floor through an amendment because finding offsets (other accounts within the bill) for any additional funds for the program is virtually impossible.
However, there may still be a chance for increased funding when the bill is finalized in the House/Senate conference committee. The AIDS Action Council, the leading Washington AIDS lobbying group, says that it believes there is a willingness by Congress to increase funding for HOPWA. This can only happen if the Administration and enough senators demand an increase for HOPWA when the VA/HUD Appropriations bill reaches the conference process.
AIDS Action is encouraging people living with HIV/AIDS to call the Senate and the Administration to ensure that HOPWA remains a priority and gets a funding increase in conference.
Pennsylvania Republican Arlen Specter is a member of the VA/HUD appropriations committee. His Washington office can be reached at 202-224-3121. The White House telephone number is 202-456-1111.
Herpes virus implicated in retinal infections
University of California at San Francisco eye researchers, using a novel and highly specific DNA-analysis method, have identified the herpes simplex virus as the sole cause of retinal infections in two people with AIDS.
This is the first time that the herpes simplex virus (HSV) has been unquestionably described as the culprit causing viral retinitis -- a damaging inflammatory eye disease that sometimes leads to blindness -- in people with AIDS.
"HSV retinitis is extremely uncommon," says Todd Margolis, MD, Ph.D., UCSF associate professor of ophthalmology. "Eye infections in people with AIDS are typically thought to be the result of cytomegalovirus (CMV) retinitis -- a chronic, destructive eye infection that can cause blindness."
The finding is important, Margolis says, because knowing the cause of the inflammatory eye diseases in people with AIDS can help researchers develop more effective drugs and help clinicians apply more appropriate treatments.
The UCSF researchers developed a PCR test specifically to diagnose HSV retinitis. They found that in two retinitis cases, one tested positive for HSV-1 and the other tested positive for HSV-2. The other 90 tested negative for HSV retinitis and were eventually diagnosed with disorders caused by CMV or varicella-zoster virus, which account for most of the viral eye infections in people with AIDS.
"The development of a highly specific PCR-based assay to detect and distinguish HSV-1 and HSV-2 DNA offers the possibility for the rapid diagnosis of these infections," Margolis said.
Research questions switch to ddI for AZT-intolerant patients
A report from the Alpha International Coordinating Committee indicates that there are no clinical advantages for symptomatic HIV-positive patients who switch from AZT to didanosine (ddI) monotherapy because of AZT intolerance.
The Alpha trial was a multicenter, randomized study, in which 1,775 HIV-positive patients received one of two doses of ddI.
In the July issue of AIDS, Dr. Janet Darbyshire of the MRC HIV Clinical Trials Center in London and associates write that there was no significant difference between the two doses of didanosine under study in terms of mortality or disease progression in this patient population.
The trial was conducted primarily in Europe, and involved 145 clinical centers in 10 countries. The subjects, the majority of whom had AIDS (60%) at enrollment, were followed for a mean of 12.4 months while receiving ddI at 10.5 mg/kg per day or 3.3 mg/kg per day. All of the subjects were zidovudine-intolerant with no prior history of treatment with didanosine.
There was no significant difference in survival between the groups; 67% of patients in each group died, according to the researchers. And the average difference in survival time between the two groups was only about 0.5 months. There was also no significant difference in progression to AIDS or death, development of HIV encephalopathy or death, or development of new AIDS events or death.
Patients on the higher didanosine dose experienced more frequent side effects, which included pancreatitis, peripheral neuropathy, abnormal liver function and dry mouth.
The researchers call the Alpha trial the ...most powerful study of ddI monotherapy conducted in HIV disease to date that uses mortality as the primary endpoint. They also believe that ...it is unlikely that an important clinical difference was missed by the trial.
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