A round-up of news about access to treatments with links to sources
6 September 2004. Related: Treatment access.
Graham McKerrow, HIV i-Base
Effects of generic FDC similar to other HAART regimens, says study
A clinical trial in field conditions of a fixed dose combination (FDC) of generic versions of nevirapine, stavudine and lamivudine – called Triomune and increasingly commonly prescribed in the developing world – shows that its effectiveness and tolerability are similar to that reported with other HAART regimens in patients with comparable baseline HIV disease status.
This research is of vital importance because although generic FDCs are widely accepted as assisting adherence and have been prequalified by the World Health Organisation for use in poor countries and are widely used, they are not accepted by some of the major donor agencies owing to scarcity of clinical data on effectiveness, safety and quality.
Researchers from France, Cameroon and Médecins Sans Frontières, followed 60 patients in an open label, 24-week multicentre trial in Cameroon. The patients received one tablet of the FDC twice daily. The primary outcome measure was the proportion of patients with viral load less than 400 copies/mL at the end of the study period.
At baseline, 92% of patients (n=55) had AIDS; median CD4 count was 118 cells/mm3 (IQR 78-167) and median plasma HIV-1 RNA was 104,000 copies/mL (~41,000-243,000). The proportion of patients with undetectable viral load (<400 copies/mL) after 24 weeks of treatment was 80% (95% CI 68-89). Median (IQR) changes in viral load and CD4 counts were -3·1 log10 copies per mL (-2·5 to -3·6) and +83 cells/mm3 (40-178) respectively. The probability of remaining alive or free of new AIDS-defining events was 0·85 (95% CI 0·73-0·92).
The researchers tested the seven batches of Triomune, produced by Cipla in India, and noted that the unit dose of every component was as claimed
The researchers write: “Our findings lend support to use and funding of a generic fixed-dose combination of nevirapine, stavudine, and lamivudine as first-line antiretroviral treatment in developing countries.”
Ref: Laurent C, Kouanfack C, Koulla-Shiro S,et al. Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavudine, and lamivudine in HIV-1-infected adults in Cameroon: open-label multicentre trial. Lancet 2004, Vol 364,No 942829-34
Tenofovir price reduced in Africa and LDCs – but not Latin America and Caribbean
Gilead has announced that tenofovir (Viread) will be available to private and public programmes in every country in Africa and in 15 additional least developed countries for $24.71 for a 30-days supply, one-third lower than its current ‘non-profit’ price.
The company intends to make the fixed-dose combination of tenofovir and FTC (emtricitabine) available through the programme now that it has received US regulatory approval. However, apart from Haiti, Latin America and the Caribbean are excluded from this programme -only Argentina is mentioned separately as a country where tenofovir is marketed. Despite having much weaker economies these countries must pay the full US price plus distribution and shipping.
Request forms can be submitted via the internet or by email, mail or fax. The company is prepared to ship tenofovir to qualifying programmes as soon as request forms are reviewed and approved.
Complete programme information and request forms are available at:
http://www.gileadaccess.org
Source: Gilead press release
http://www.aegis.org/news/bw/2004/BW040704.html
WHO removes three Ranbaxy generics from its prequalification list
The World Health Organisation has removed three generic antiretroviral medicines from its list of prequalified medicines following an inspection of a contracted laboratory that had carried out bioequivalence studies of the drugs. The laboratory was found to be “non-compliant with international standards of good clinical and laboratory practice”. The drugs will be removed from the list of approved drugs until the manufacturer, Ranbaxy, can submit data from new studies proving the products’ bioequivalence with the originator brand name medicines.
The three medicines affected are combinations pills: two containing lamivudine, stavudine and nevirapine in two different strengths, and one containing lamivudine and zidovudine (AZT). Ranbaxy will resubmit the medicines for new tests at a different laboratory. If and when the laboratory and the products are approved the WHO will reinstate them on the list of prequalified medicines.
A similar inspection in May of a laboratory contracted to Cipla resulted in the removal from the prequalified medicines list of two of Cipla’s products: Lamivudine and a combination of lamivudine and zidovudine.
The full WHO announcement is at:
http://www.who.int/mediacentre/releases/2004/pr53/en/
Ranbaxy to seek FDA approval for its generic ARVs
The generic drug manufacturer Ranbaxy Laboratories Limited of New Delhi will file its antiretroviral drugs with the US Food and Drug Administration under the expedited review process of the US FDA for the US President’s Emergency Plan for AIDS Relief (PEPFAR). The first filing is likely to take place before the end of the year. The first study for bio-equivalence is being planned at a contracted laboratory in North America. Only FDA approved drugs can be bought with the $15bn being made available through PEPFAR to tackle HIV in 15 countries.
Full company announcement:
http://www.ranbaxy.com/newsroom/pressrelease_det.asp?sno=166
South Africa withdraws approval of Cipla’s Duovir
The South African Medicines Control Council (MCC) has declared the use of the antiretroviral Duovir “undesirable” and has enforced a recall of all stocks of the medicine. Duovir combines zidovudine (AZT) and lamivudine in a combination similar to Combivir manufactured by GlaxoSmithKline.
Duovir has been withdrawn from the market because the MCC has concerns regarding the quality of the bioequivalence studies that formed the basis of the medicine’s registration. The problems around these studies do not imply that Duovir is not bioequivalent, but the onus is on Cipla to prove bioequivalence in order for the MCC to approve Duovir.
The Treatment Action Campaign and Médecins Sans Frontières have issued a joint statement calling on Cipla to act speedily to address the MCC’s concerns/
Source: TAC-MSF joint statement